Archive for the ‘Genetic Testing’ Category

Wilmington, Delaware, United States: Continuous developments in the biopharmaceutical field are projected to create profitable business opportunities in the global sterility testing market in the forthcoming years. Moreover, increase in the number of sterility testing performed by companies operating in the medical device manufacturing is estimated to play important role in market expansion.

Sterility testing refers to a set of activities that are performed to confirm that the products are microorganism-free. While performing these tests, aseptic conditions are maintained. Over the period of past few years, the healthcare and medicine industries have experienced substantial advancements. Moreover, a notable growth in the launches of new kits, reagents, and medical devices is observed in the recent past. These factors are estimated to create lucrative prospects in the global sterility test market.

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The global sterility testing market is being driven by several factors such as rise in the use of automated products, introduction of latest software that help in rapid analysis of data, and increasing participation of research institutes. Moreover, a surge in global population, increase in supportive healthcare insurance coverage, improved healthcare expenditure, and increasing cases of rare and chronic diseases are several key factors bolstering market growth.

Several key market players such as Sartorius AG, Merck KGaA, bioMrieux, Inc, and Thermo Fisher Scientific Inc. are increasing investments in R&D projects, which are focused on the development of products that offer improved sterility testing techniques. Moreover, several companies are increasing efforts to introduce innovations in their existing products. At the same time, companies are also indulging in merger and acquisition activities. These factors are likely to propel the sterility testing market in the years ahead.

North America is one of the prominent regions in the sterility testing market owing to several factors such as launch of new biopharmaceutical firms, surge in the demand for sterility testing, and early adoption for advanced technology in the region.

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Sterility Testing Market: Snapshot

The sterility testing market is rising with increasing number of dental visits across the globe. The sterility testing market was valued over US$ 750.0 Mn in 2016 and is projected to witness cumulative annual growth rate (CAGR) of over 7.0 % from 2017 to 2025 to surpass the value of US$ 1500.0 Bn by 2025. The global market growth is attributed to increase in the demand for automated products, development of software to support rapid data analyses and growing involvement of research institutes etc.

Growth of the sterility testing market is attributed to rising population, technological advancements in rapid sterility test, increase in healthcare expenditure, favorable healthcare insurance coverage, rising prevalence of chronic and rare diseases. According to U.S. Department of Commerce the percentage of people covered by any type of health insurance increased by 1.3 percentage to 90.9 percent in 2015, up from 89.6 percent in 2014.

New product innovation, merger and acquisition for product development, government support for research and development are another factors which will fuel the global sterility testing market. Advances in technology in the past few years have enabled the development of new sterility test methods that yield accurate and reliable test results in less time and with less operator intervention than the currently prescribed methods. Strategic acquisitions have strengthened the market position of key players, leading to market consolidation. This is a major trend observed in the global sterility testing market. Moreover, collaborations among key market players enable them to expand their global reach.

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Sterility Testing Market: Segment outlook

The sterility testing market is broadly segmented into four categories based on product type, by application, by test type and by region. In terms of product type, the global market is categorized into kits and reagents, instruments and others. The kits and reagent segment accounted for the largest share of the global sterility testing market in 2016, and is expected to dominate the market in term of revenue during the forecast period from 2017 to 2025. Factors such as increase involvement of institute for research and development activity, requirement for repetitive purchase of kits and reagents and easy product affordability etc. are the accelerating the kits and reagent market.

The instrument segment is likely to register strong growth during the forecast period. In terms of application, the global market is categorized into biopharmaceutical manufacturing, medical devices manufacturing and others. Pharmaceutical manufacturing segment is dominating and highly growing segment. In terms of test type, the sterility testing is segmented into traditional sterility tests and rapid sterility tests. Traditional sterility testing is the most lucrative test type segment. Advantages such as low initial set up cost, time to return on investment is short to several month are the key factors accelerating the traditional sterility testing segment.

Sterility Testing Market: Regional outlook

Geographically, the sterility testing market is segmented into North America, Europe, Asia Pacific, Latin America and Middle East & Africa. North America dominated the global market and is projected to gain its market share by the end of 2025. This is due to establishment of new biopharmaceutical companies, rising demand for sterility testing, early adoption for advanced technology will fuel the North America sterility testing market. However, the market in Asia Pacific is projected to register a significant growth rate by 2025 due to growing R&D investment, increasing number of pharmaceutical and biopharmaceutical companies and rising demand for drug products in the region.

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The Asia Pacific market is expected to expand at a highest CAGR in the forecast period from 2017 to 2025 due to rising demand for drug products in the region. The rapidly growing pharmaceutical industry has also attracted the focus of public and private groups toward the safety profile of products, leading to increase in demand for sterility testing.

The companies like Merck KGaA, bioMrieux, Inc, Sartorius AG, Thermo Fisher Scientific Inc., accounted for the major share in global sterility testing market in 2016. bioMrieux SA is increasing investments in the industrial application segment to scale up the production capacity of its Craponne (France) and Lombard (the U.S.) facilities. Other global players operating in the market include Sartorius AG, Becton, Dickinson and Company and Rapid Micro Biosystems, Inc. Focus on research and development for expansion of product portfolio is the key strategy adopted by leading players.

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Sterility Testing Market: The Kits and Reagent Segment is Expected to Dominate the Market During the Forecast Period - BioSpace

TAMPA, Fla., June 7, 2022 /PRNewswire/ -- Pinnacle Fertility (Pinnacle), the fastest-growing network of physician-centered fertility practices representing more than seven clinics and 20 locations nationwide, has partnered with Igenomix as their exclusive preimplantation genetics testing (PGT) laboratory and provider for genetic counseling services. Continuing Pinnacle's commitment to collaborative medical leadership and patient-first care, this strategic partnership was the result of the Medical Council's collective determination and offers patients an increased opportunity to find success in their family-building journey.

"Our Medical Director Council extensively studied the science behind major genetic labs to determine which would provide us with the best possible data to make key decisions. Bringing Igenomix on as our exclusive genetics provider for Pinnacle Fertility clinics continues to ensure that we meet our single guiding principle which is to provide the best patient outcomes possible," shares Dr. Richard Marrs, Chief Medical Director for Pinnacle Fertility.

With more than 15 years of experience, Igenomix is the global leader in reproductive genetics and focuses on quality, safety, and science to help healthcare professionals and patients detect genetic abnormalities before treatment, avoid implantation failure, and ensure patients achieve a healthy pregnancy.

"Pinnacle Fertility continues to set the standard in fertility care by bringing leading technology, integration and innovation to its suite of family building services. Partnerships with companies like Igenomix, who are committed though-leaders like we are, benefit our patients and those seeking to grow their families with the help world-class reproductive genetic testing and counseling services," says Andrew Mintz, CEO at Pinnacle Fertility.

PGT is an elective treatment option that can be used to identify embryos at risk of having a specific genetic or chromosomal condition and is available for patients at all fertility clinics within the Pinnacle network. Igenomix offers the most comprehensive portfolio of infertility treatments for genetics and was the first organization to launch non-invasive PGT-A services. Patients who choose to use PGT as part of their treatment plan receive complementary pre- and post-test genetic counseling to help guide and educate them on their options and results.

"Bringing Igenomix onboard is an exciting opportunity for our patients to seamlessly have access to genetic testing and counseling services, such as PGT at our fertility clinics," shares Dr. Dr. Priya Maseelallfrom Reproductive Gynecology and Infertility "The genetic counselors are perfectly integrated into our programs and champion our patients' success like we do."

Patients electing to use PGT, undergo in vitro fertilization (IVF) to create embryos, and then cells are removed from each embryo for genetic testing. Embryos with normal results are selected to be transferred into the uterus in hopes of achieving a pregnancy and delivering a child without a genetic condition. By utilizing PGT, genetic diseases can be prevented. In addition, studies have shown that PGT can not only improve success rates but also provide optimism and peace of mind during pregnancy and after birth.

About Pinnacle Fertility

Pinnacle Fertility is the nation's fastest-growing physician-centric fertility care platform, supporting high-performing fertility clinics and comprehensive fertility service providers nationwide. Under a united mission of fulfilling dreams by building families, Pinnacle clinics offer innovative technology and processes, compassionate patient care, and comprehensive fertility treatment services, ensuring families receive a high-touch experience on their path to parenthood.

For more information about Pinnacle Fertility, visit pinnaclefertility.com

About Igenomix

Igenomix is a global leader in reproductive genetic testing with laboratories in 23 countries and assisting hundreds of thousands of patients per year worldwide. As part of Vitrolife Group, the company is recognized for its R&D expertise and quality of service. In the US, Igenomix has proven to be the best-in-class when comes to credibility, consistency on their results, automatization of their laboratories and the most important, patient care.

Learn more about Igenomix at Igenomix.com

Contact:Walt Conrad[emailprotected]

SOURCE Pinnacle Fertility

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PINNACLE FERTILITY PARTNERS WITH IGENOMIX AS THEIR EXCLUSIVE GENETICS LABORATORY AND GENETIC COUNSELING PROVIDER - PR Newswire

Abbott Nutrition has resumed formula production in its Michigan plant to address the nationwide formula shortage; 2 distinct strains of monkeypox may indicate rapid, undetected spread nationwide; the overturn of Roe v Wade could have an effect on in vitro fertilization and genetic testing.

Abbott Nutrition resumed production of baby formula on Saturday in order to address the nationwide shortage after getting the green light from the FDA. Production of EleCare and other specialty and metabolic formulas will be the first to restart production, with a product release of June 20 as the target date, according to CNBC. Abbott Nutrition was initially closed in February due to contamination. The FDA has said in a statement that it is working diligently to ensure safe resumption of infant formula production. The FDA also said that it hopes that this measure will put more baby formula on the shelves nationwide.

A recent genetic analysis of monkeypox cases indicated that there are 2 distinct strains in the United States, which could mean that the virus has been circulating in the country for some time, according to AP News. There are many monkeypox cases with the same strain as the recent cases in Europe; however, the recent analysis showed a different strain as well and both strains were in the United States last year. More analysis will need to be done to determine how long monkeypox has been in the United States. These findings could mean that the virus will be difficult to contain in the future.

The overturning of Roe v Wade could have effects on reproductive medicine at large as state policies could determine how birth control is provided or in vitro fertilization (IVF), according to STAT News. In the states that are expected to ban or limit abortion, lab-made embryos would also have legal protections, which could make IVF more complicated. Preimplantation genetic testing could also come under scrutiny as embryos that arent implanted may not be able to be frozen if they are considered people with legal rights. Alabamas anti-abortion law only applies to embryos in the womb, which would allow IVF; however, experts are still figuring out whether Oklahomas anti-abortion law will also extend to IVF.

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What We're Reading: Abbott to Resume Formula Production; 2 Strains of Monkeypox; Impact of SCOTUS Decision on IVF, Embryo Genetic Testing - AJMC.com...

From left, Farah Khan, Tracy Ismail, Sophia Ahmed, Amara Ismail and Durrah Khan

Three siblings have already had their stomachs removed after testing positive for a faulty cancer gene following the deaths of their mother and sister from the disease.

Now further members of the family have been found to carry the faulty gene, with several children, who are too young to be tested, under threat of inheriting it.

Walsall siblings Sophia Ahmed, 42, Tahir Khan, 48, and Omar Khan,31 underwent the surgery after a series of tests at Addenbrooke's Hospital in Cambridge.

The family joined Cancer Research UKs Familial Gastric Cancer study after losing their mum and sister to hereditary stomach cancer.

Determined to give back to the charity that has given them hope, Sophia, who has recently had her breasts removed as well as her stomach, is joining with four other female relatives to help launch Cancer Research UKs Race for Life Pretty Muddy events across the region.

Sophia and her two brothers took their radical decision to have their stomachs removed after genetic testing showed they had the CDH1 gene and were at high risk of the same cancer that killed their mother, Pearl Khan, in 2002 at the age of 49, and their sister, Yasmin Khan, in 2012 at the age of 32.

The family team named Little Hooligans Get Dirty for Cancer - is being led by Amara Ismail, 32, manager of the Little Hooligans soft play centre in Walsall, and her mum Tracy Ismail, 51, the only one of the five siblings unaffected by the gene. Joining Amara is her cousin, Farah Khan, 23, whose father Tahir had preventive surgery to remove his stomach.

Youngest of the team is 14-year-old Durrah Khan, whose mum, Yasmin Khan, passed away from stomach cancer in 2012. It was Yasmins death that spurred the rest of the family to find out about research being done in the area, and led to them joining the Familial Gastric Cancer study.

Farah has also tested positive for the faulty gene and is taking part in the same Cancer Research UK research study as her father. She is regularly monitored at Addenbrookes hospital in Cambridge and may also be offered the opportunity to have preventative surgery.

Sophia said: Having your stomach removed is a fairly drastic thing to do, but after I had the surgery they told me that the cancer had already started in my stomach and I would have been dead within a year if it hadnt been removed. I was at very high risk of breast cancer too, so a double mastectomy was the best way to prevent it.

Research is so important. Its thanks to research that Im alive, and that other members of my family are still here too. I truly believe that more research could lead to the complete eradication of this genetic form of cancer.

The team has signed up for Pretty Muddy Sandwell - a mud-splattered obstacle course that raises money for life-saving research - which takes place at Sandwell Valley Country Park on Saturday, June 25. There is also the chance for boys and girls aged five to 12 to take part in Pretty Muddy Kids - their own version of the fun event.

Amara said: Cancer research UK is a very close charity to me and my family. My aunt Yasmin was the same age as I am now when she passed away. My surviving auntie and two uncles have all had preventative surgery at Addenbrookes hospital with the help of Cancer Research UK. Their very high risk of cancer was discovered after they had genetic testing which showed they had the CDH1 gene.

I am very fortunate in that my mum was the only one of five siblings not to have the faulty gene, so it hasnt been passed onto me either. But the impact on my wider family has been huge and has affected every generation.

My cousin's genetic tested showed she also had the faulty gene and she is now waiting to find out how it is going to affect her life. We have a further six children, including Durrah who is part of the Pretty Muddy team, who are yet to reach the age where they can be tested.

Were so grateful for this research study that is helping all of us stay healthy and avoid cancer. But also, as a family we're invested in helping our future generations.

Farah, who inherited the genetic fault from her father, Tahir, is regularly screened for the disease. She said: Its good to know that screening will pick up early signs of any problems and that, like my dad, I can take steps to prevent cancer in the future.

Jane Redman,Cancer Research UKs spokesperson in the West Midlands, said: We are incredibly grateful to all the wonderful ladies from this special family their support. Their story speaks volumes about how important research is and why we need to keep funding it.

Our Race for Life eventsareopen to all. For some people, the Race for Life is literally a walk in the park. For others, its a jog. Some may opt to push themselves harder, taking up the challenge of Pretty Muddy or even pushing for a new personal best time.

Were looking forward to welcoming people of all ages and abilities. Race for LifePretty Muddy in Sandwellwill be a fun, emotional, colourful, uplifting and unforgettable event this year.

To enter, visitraceforlife.org. To sponsor the team, go to fundraise.cancerresearchuk.org/team/little-hooligans-gets-dirty

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Black County family affected by genetic cancer in action plea - Express & Star

Includes oral presentation onProspera test's two-threshold algorithm, showing the combination of donor quantity and donor fraction outperformsdonor fraction alone

AUSTIN, Texas, June 8, 2022 /PRNewswire/ -- Natera, Inc.(NASDAQ: NTRA), a global leader in cell-free DNA (cfDNA) testing, today announced that ithas presented data on the clinical utility of the company's Prospera and Renasight tests in 14 sessions at the American Transplant Congress (ATC) 2022 meeting. This expands on the thirteen peer-reviewed papers that have been published over the last twelve months, demonstrating the strong performance of both assays.

Phil Halloran, M.D., Ph.D., director of the Alberta Transplant Applied Genomics Centre, presented new data on the latest findings of the global, multisite, prospectiveTrifecta study, "Combining fraction and estimated amount of dd-cfDNA to assess kidney transplant rejection using molecular diagnoses and histology." The study demonstrates that the new two-threshold algorithm for the Prospera test - includingboth dd-cfDNA fraction and quantity -performed better than dd-cfDNA percentage alone in detecting active rejection, with an AUC of 0.88 when compared against molecular biopsy assessment and 0.82 when compared against histological biopsy assessment. This analysis in the Trifecta study features 367 fully-biopsy-matched samples from the 22 participating clinics in the U.S. and Europe.

"The data presented at ATC, combined with other important studies, highlight Natera's dedication to innovation and continued leadership in testing for transplant rejection and genetic risks for kidney disease," said Sangeeta Bhorade, M.D., chief medical officer for organ health at Natera. "The evidence continues to support the use of Natera technology for aiding clinicians in making major care decisions for transplant patients."

Data from theTrifecta study was also presented inthree other ATCsessions, and a full listing of Natera's scientific sessions and presence can be found at https://www.natera.com/events/prospera-conference/

About the Prospera test

The ProsperaTM test leverages Natera's core single-nucleotide (SNP)-based massively multiplexed PCR (mmPCR) technology to identify allograft rejection non-invasively and with high precision and accuracy, without the need for prior donor or recipient genotyping. The test works by measuring the fraction of donor-derived cell-free DNA (dd-cfDNA) in the recipient's blood. It may be used by physicians considering the diagnosis of active rejection, helping to rule in or out this condition when evaluating the need for diagnostic testing or the results of an invasive biopsy. The Prospera test has been clinically and analytically validated for performance regardless of donor relatedness, rejection type, and clinical presentation. It has been developed and its performance characteristics determined by Natera, the CLIA-certified laboratory performing the test. The test has not been cleared or approved by the US Food and Drug Administration (FDA). CAP accredited, ISO 13485 certified, and CLIA certified.

About the Renasight test

The RenasightTM test is a germline genetic test that screens for hereditary causes of kidney disease. It is indicated for patients with diagnosed kidney disease and is run from a patient's blood or saliva sample. Providers can use the Renasight test to identify a genetic predisposition, clarify a clinical diagnosis, or identify the etiology of an unknown kidney disease to help inform medical management. Additionally, genetic counseling and familial testing can be offered based on the test result. The test has been developed and its performance characteristics determined by the CLIA-certified laboratory performing the test. The test has not been cleared or approved by the U.S. Food and Drug Administration (FDA). CAP accredited, ISO 13485 certified, and CLIA certified.

About Natera

NateraTM is a global leader in cell-free DNA testing, dedicated to oncology, women's health, and organ health. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that help lead to longer, healthier lives. Natera's tests are validated by more than 100 peer-reviewed publications that demonstrate high accuracy. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas and San Carlos, California. For more information, visit http://www.natera.com.

Forward-Looking Statements

All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera's plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera's expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to whether the results of clinical or other studies will support the use of our product offerings, our expectations of the reliability, accuracy and performance of our screening tests, or of the benefits of our screening tests and product offerings to patients, providers and payers. Additional risks and uncertainties are discussed in greater detail in "Risk Factors" in Natera's recent filings on Forms 10-K and 10-Q and in other filings Natera makes with the SEC from time to time. These documents are available at http://www.natera.com/investors and http://www.sec.gov.

Contacts

Investor Relations: Mike Brophy, CFO, Natera, Inc., 510-826-2350

Media: Kate Stabrawa, Communications, Natera, Inc., 720-318-4080 pr@natera.com

View original content to download multimedia:https://www.prnewswire.com/news-releases/natera-showcases-leadership-in-transplantation-at-atc-2022-with-new-data-on-its-prospera-and-renasight-tests-301563616.html

SOURCE Natera, Inc.

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Natera Showcases Leadership in Transplantation at ATC 2022 with New Data on its Prospera and Renasight Tests - BioSpace

Quenton Tompkins family tree is deeply rooted in rural McCormick County, South Carolina.

His grandfather was a sharecropper in McCormick. His mother, who turns 88 this month, grew up as the youngest of 24 children. Branches of aunts, uncles, and cousins now stretch from Florida to Chicago.

And although 48-year-old Tompkins has heard plenty of stories, his family holds its secrets, too.

He didnt know until he was an adult that his grandfather died of leukemia. And hes still unsure if his fathers bout with prostate cancer runs in the family. Tompkins mother and her siblings have dealt with a range of health issues, including diabetes, heart attacks, and strokes, but he still doesnt know what killed his grandmother more than 70 years ago.

Those are questions I go through personally, said Tompkins, a lobbyist for the Medical University of South Carolina. Theres another side to knowing where you come from.

Twenty-two years ago, President Bill Clinton announced the completion of a draft version of the Human Genome Project, a breakthrough he described as the language in which God created life. He predicted that scientists, armed with genetic discoveries, would find cures for Alzheimers disease, cancer, Parkinsons disease, and diabetes in the coming years.

Clintons prediction, of course, hasnt yet come to pass. But researchers in Charleston are hopeful that a large genetics research project underway across South Carolina may help scientists address some of the states persistent health disparities, which disproportionately impact its Black residents and regularly rank among the nations worst.

The university health system intends to enroll 100,000 of South Carolinas 5 million residents in genetic testing over the next four years in hopes of better understanding how DNA influences health. Researchers also want to recruit participants who reflect the diversity of the states population.

Its an ambitious goal. With nearly 27% of South Carolina residents identifying as Black or African American, the MUSC genetics research project, called In Our DNA SC, would if successful accomplish something most other genetics research projects have failed to do. Historically, diverse participation in this type of research has been very low.

Theres a trust factor. Its plain and simple, said Tompkins, who is developing an outreach program for the project.

He referenced Henrietta Lacks, a Black woman in Baltimore whose cells were used without her or her familys knowledge for research purposes by doctors at Johns Hopkins University in the 1950s, and the Tuskegee syphilis study, conducted over nearly 40 years starting in the 1930s. Researchers deceived hundreds of Black men enrolled in the study, telling them they were being treated for syphilis when, in fact, they were left untreated, even after penicillin became widely available.

Those are still fresh in many peoples minds, Tompkins said. Weve come a long way from those stories it doesnt dismiss what happened but there are a lot more controls and oversight in place to ward those things off from happening again.

But its not only history feeding this distrust. Bias and racism evident in medicine today contribute to the problem.

Diversity in genetics research is so low that approximately 90% of participants in projects launched since the first sequencing of the human genome have been individuals of European descent or those who identify as white, said Dr. Shoa Clarke, a pediatric cardiologist and geneticist at Stanford University.

These numbers affect real-life health care. Clarke and others published research last year showing that a DNA-based tool used to assess a patients risk of developing high cholesterol works reliably well only when administered to those of Northern European descent. Thats because the tool was developed using information from genetic bio-banks largely made up of DNA from white people. And aside from a large DNA bank compiled by the Department of Veterans Affairs, this is generally the norm.

Human beings, regardless of race, are more than 99% genetically identical, but small variations and mutations passed down through generations can influence health outcomes in huge ways, Clarke explained.

Genetics is not the cause of health disparities, he said. But as we move toward using genetics in clinical settings, its very possible they could create new disparities.

In South Carolina, health disparities between Black and white patients are already acute, said Marvella Ford, a researcher at MUSCs Hollings Cancer Center in Charleston.

South Carolina compared to the rest of the country were usually in the bottom tier, Ford said. The prostate cancer mortality rate in South Carolina, for example, is 2 times higher for Black men than white men, she said.

When you look at most other chronic conditions, she said, you see the same thing.

She called the genetics project at MUSC a great opportunity to open the doors. Even so, the topic of recruiting Black research participants for genetics studies is complex.

Theres debate on how we should be doing this work, said Shawneequa Callier, an attorney and an associate professor of bioethics at George Washington University. Theres just so much diversity in Africa. Its the cradle of humanity.

Men and women transported to Charleston and other American port cities during the transatlantic slave trade came from a wide region of Africa mostly from West Central Africa, but in large numbers from regions farther north, too. Once in America, they were often separated and forced hundreds of miles apart. This explains why someone whose ancestors lived on one of South Carolinas barrier islands may have inherited different genetic variants than someone from a multigenerational Black family inland in McCormick County, just north of Augusta, Georgia.

Thats also why categorizing genetics research participants simply as Black or African American, without more context, may not yield particularly useful research insights, Callier said.

If you dont study the data and study it well, thats a real dereliction of ethical duty, Callier said.

Those who choose to participate in the MUSC project stand to benefit from it directly, its organizers said. After submitting a saliva sample, each participant will receive a report indicating if they have one or more of three genetic conditions that may put them at a higher risk for heart disease and certain cancers such as one of the BRCA mutations linked to breast cancer. If they test positive for one of these conditions, they will be connected at no cost to a genetics counselor, who can assist with information and treatment options related to a patients inherited risks. Participants will also learn where their ancestors likely lived.

The de-identified DNA data will then be used by researchers at MUSC, as well as those at Helix, a private California-based genomics company, which will process the saliva samples and extract the genetic information from each participants sample. Researchers at MUSC and Helix have indicated they hope to use the results to better figure out how DNA affects population health. Heather Woolwine, an MUSC spokesperson, said the project will cost $15 million, some of which will be paid to Helix. Hospital revenue will fund the research, she said.

Tompkins expects to receive a lot of questions about how it all will work. But hes used to questions. He said he encountered much of the same hesitancy when he helped set up MUSC covid testing and vaccine sites across the state. Many people regardless of race worried microchips or tracking technology had been embedded into the covid vaccines, he said.

Tompkins found that the key to persuading residents in rural parts of the state to consider the covid vaccine was to seek out invitations from trusted, local leaders, then set up events with them. South Carolinas covid vaccination rate remains lower than the national average, but Tompkins said some skeptics have been more receptive to MUSCs message because the hospital system has focused on building relationships with organizers outside Charleston. He hopes to use those relationships to spread word about the new genetics research project.

You have to build those relationships and find community champions that can help you open doors and gather people, he said. Then, its about letting them choose.

Lauren Sausser: lsausser@kff.org,@laurenmsausser

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Addressing the Trust Factor: South Carolina Researchers Tackle Health Disparities Using Genetics - Kaiser Health News

CARMEL, Ind. The founder of the Safe Haven Baby Boxes claims the Department of Child Services is giving a surrendered infant back to his parent without doing a DNA test first.

We cannot be just pretty sure that this is the bio parent, their words, not mine, Monica Kelsey, founder of the Safe Haven Baby Boxes, said in a popular video posted to social media.

Kelsey said she has spoken with a relative of the woman claiming to be the mother of an infant surrendered in a Carmel Safe Haven Baby Box in mid-May. She said the family member says a DNA test has not been done yet the reunification process has started.

Kelsey said the anonymity of these boxes is crucial to this service, and in all cases makes it impossible to figure out who the biological mother is without DNA testing.

No cameras are around these boxes and so, mother or a father places this child inside this box, there is no way for us to know who that parent is, Kelsey said.

The baby boxes are located at fire stations and hospitals around the state. Kelsey said once a baby is placed in the box, they are given medical care and then taken to the states Department of Child Services.

If theyre not going to do a DNA test or a drug test, or vet this family, we know has not happened, Kelsey explained. We have contact with the family. We know this has not happened yet. I have a problem with that. I have to be this little guys voice.

We investigated these claims, and reached out to DCS. The agency said the safe haven law prevents them from discussing a particular case, but they gave us this statement:

A social media post has raised questions regarding the steps the Indiana Department of Child Services takes after a baby is surrendered under theIndiana Safe Havenlaw.

It is common for children to come into DCS care without the identity of one or both parents being immediately known. DCS would never, under any circumstance, send a child home with someone claiming to be their parent without first confirming with certainty that persons relationship to the child. This may include genetic testing, along with many other steps to ensure safe reunification if it is in the best interest of the child. If an individual comes forward claiming parentage, DCS works hand in hand with the juvenile court to determine whether the child was surrendered with the knowing consent of both parents.

Information regarding Safe Haven surrenders is sealed under Indiana law as part of confidential juvenile records, and, with few statutory exceptions, only parties to the case are privy to those details.

Indiana law does not address this specific situation. We know it has captured the attention of State Senator Travis Holdman is aware of this situation and is in communication with DCS.

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Baby Box founder claims infant will be given back to parent without DNA test - FOX 59 Indianapolis

NEW YORK Based on findings from a small pilot study in a relatively well-off patient population in London, a UK team has suggested that a combination of whole-genome sequencing, panel sequencing, and comprehensive medical testing and imaging is feasible in a family practice setting and may benefit patients and their families.

Ros Eeles, a researcher with the Institute of Cancer Research and the Royal Marsden NHS Foundation Trust shared early findings from the study at the American Society of Clinical Oncology's annual meeting in Chicago on Friday. Together with Michael Sandberg, a general practitioner and medical director at the private healthcare center 90 Sloane Street, she co-led the 90S Study, named in a nod to that central London center.

"We had a group of specialists who wanted to look at what would happen if you brought whole-genome sequencing into primary care," Eeles said, noting that the 90 Sloane Street center has built in electrocardiogram, echocardiogram, abdominal and pelvic ultrasound, and routine blood test capabilities.

In the context of cancer, for example, germline and somatic mutations can impact everything from disease screening to treatment strategies, for example. Indeed, large-scale clinical and population sequencing studies looking at germline genetic variation and their ties to human traits or disease are increasingly common, as are efforts to characterize germline and somatic mutations in cancer patients.

But studies on the potential for sequencing individuals in a family medicine setting are much rarer, and it remains to be seen whether the approach is feasible, scalable, cost-effective, and/or beneficial for patients with or without an existing diagnosis.

"What we wanted to ask was, 'Should you use whole-genome screening in next-generation health screening in primary care?'" Eeles said.

For the pilot stage of the study, the team had thirtyfold average whole-genome germline sequencing done commercially on 104 seemingly healthy individuals ranging in age from 29 to 82 years old, who were recruited between 2020 and 2022. The participants tended to have high socioeconomic status and more than 94 percent had a family history of cancer or cardiac disease in a first- or second-degree relative.

All but one of the participants was symptom-free, and 13 had a history of cancer. European ancestry was reported for more than 95 percent of those enrolled.

Since researchers had their sights set on finding as many informative variants as possible, they rounded out short-read genome sequence data with targeted panel sequence data to try to avoid missing deletions. They profiled pharmacogenomics-related variants, polygenic risk contributors, and other genetic features using whole-genome sequence data, which provided insights on up to 566 genes, and used targeted sequence data to search for actionable changes in dozens of cancer- or cardiac-related genes.

The team also considered participants' personal and family health histories, as well as results from a full medical with the same general practitioner. For that medical, participants were profiled with a variety of clinical screens ranging from blood tests to organ imaging.

The team opted to report only variants that could prompt actionable changes to a patient's care, she added, but they established a system for returning to suspicious variants in the genomes as the definition of actionable mutations continues to expand or evolve in the future and new drug targets turn up.

All told, the newly generated genome sequences led investigators to relatively rare, clinically actionable germline mutations in 27 study participants. They flagged cancer-related genetic risk variants in genes in 10 of the participants, for example, while two more individuals carried actionable cardiac rhythm disorder-associated variants, and still other patients had variants in genes involved in clotting, lipid metabolism, or other processes.

Far more individuals around 80 percent of individuals in the study were identified as carriers of variants implicated in autosomal recessive conditions, the team reported, including conditions that are relevant to reproductive screening programs. A significant proportion of sequenced individuals had at least one variant linked to pharmacogenomic responses.

The kinds of risky germline variants detected sometimes tracked with the new diagnoses made or with an individual's personal or family health history, but not always.

The medicals alone led to new heart disease or prostate cancer diagnoses in several study participants. On the other hand, 70 percent of individuals who ended up having cancer susceptibility-linked variants in their germline would not have been found without the genetics program, Eeles said.

"Clearly we are picking up mutations in those without a family history, and that's where geneticists giving advice is going to be important," she explained.

"The majority of patients had a significant change in management for themselves or their families," Eeles and her co-authors wrote in an abstract accompanying the ASCO presentation. "Whole-genome sequencing as part of health screening in family practice is feasible and is likely to have significant beneficial health management implications."

The team tapped into the common variant data collected from participants for a research arm of the study, which looked at polygenic risk for conditions such as colorectal cancer or prostate cancer.

While the research was done within a private clinic setting, the investigators also looked at what aspects of the program might be retained, jettisoned, or tweaked if attempting to apply it through a public health system such as NHS.

Speaking remotely at the ASCO meeting, Fergus Couch, a laboratory medicine and pathology researcher at the Mayo Clinic in Rochester, Minnesota, who was not involved in the study, noted that the 90S Study is "a really nice model for evaluating how exome sequencing, genome sequencing, or panel sequencing might actually be useful in the clinical setting."

For example, he noted that the program picked up risky variants that would have been missed by following current family- or personal medical history-based genetic testing guidelines in the UK.

Still, Couch questioned whether the patient population for the 90S Study was representative of the broader population, since family histories of disease and rates of clinically actionable changes in cancer-related genes such as BRCA1 were higher than that described in the past.

He also noted that care is needed in general when incorporating sequencing into clinical care for symptom-free individuals, not only when it comes to defining actionability or implementing information on specific variants or risk scores but also when selecting the sequencing strategy used and setting up appropriate referrals for patients with actionable variants or recessive disease carrier status.

"Could this type of sequencing and the data that comes from it actually be handled by general medicine, family medicine, or community practices around the country? Is this really just too much?" he wondered, noting that "in the absence of a very strong referral network, this could be really quite challenging for the vast majority of non-tertiary medical centers."

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UK Team Tests Whole-Genome, Targeted Sequencing in Family Practice Setting - GenomeWeb

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2022-06-08 14:56

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June 8, 2022

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Almost 20 years ago, Italy tested what it would look like if embryos were given the same rights as a living person. The country put stringent limits on in vitro fertilization treatments (IVF), banning embryo preservation, limiting the number of embryos created a time to three and mandating that they all be transferred to the uterus.

In the years the law was in place, before it was ultimately repealed in full, more IVF treatments failed, more pregnancies resulted in no live births or more multiple births, and IVF became more difficult to access and more expensive. Italian patients who could afford it traveled to other countries across Europe to receive treatment. Success rates at IVF clinics dropped, high-risk pregnancies increased and doctors had to risk transferring embryos that could lead to medical complications for the pregnant person. Single parents and many LGBTQ+ parents couldnt access IVF at all because surrogacy and sperm donation were also banned.

To doctors in the United States, Italy was an extreme example of what could happen if embryos were treated as people, even though in most cases both in the lab and in nature a large portion of embryos never become babies. Now, theyre worried that the increased barriers and cost that doctors saw in Italy is a preview of what could happen in the United States.

Any day now, the Supreme Court is likely to overturn its 1973 Roe v. Wade decision, according to a draft of the decision leaked in May, leaving the choice of how to limit abortion access up to states. The impact is expected to trickle down to fertility treatments. States including Louisiana, Nebraska and Oklahoma have tried to pass abortion restrictions that revise the definition of life to begin at fertilization and that limit or ban discarding embryos, creating the standard that led Italy to impose its IVF restrictions in 2004. While those efforts have so far failed, states are expected to try again if Roe is overturned.

Not only could a decision like that impact patients health, but it could take a procedure that is already prohibitively expensive for many families and make it even less accessible, reproductive endocrinologists told The 19th.

Already, one cycle of IVF in the United States runs patients about $23,000 on average. Most patients will go through two or more cycles before they have a successful pregnancy, a cost of about $50,000, according to FertilityIQ, which collects IVF cost data.

In a typical cycle here, IVF involves extracting 10 to 15 eggs for fertilization and testing the embryos before choosing typically one for transfer to the uterus. The rest are often frozen, donated or discarded. That approach has led to high success rates for IVF, fewer transfers, and fewer high-risk pregnancies and losses.

Limiting the number of eggs that can be extracted in a cycle, limiting genetic testing or banning embryo preservation means the likelihood that IVF treatments are successful will decrease. That means patients will have to endure and pay for more IVF transfers, and doctors will have to assume potential risks if faced with decisions about eliminating embryos.

The issue is also one of racial justice.

The fertility industry is one where the typical patient is somebody who has money, typically White, a little bit older. [It] has already been catering to a narrow population, said Kimberly Mutcherson, the dean of Rutgers Law School and a reproductive justice scholar. The majority of low-income workers are women of color, and low-income women are also most likely to have Medicaid coverage, which is prohibited from covering abortion care and does not cover IVF. Mutcherson points out that while they wont pay for IVF, most state Medicaid programs do cover some form of sterilization.

According to a survey of nearly 1,500 fertility patients published in 2020, more than 75 percent of IVF patients are White and more than 80 percent have annual household incomes higher than $100,000. Black women are the most likely to report facing barriers to fertility treatment, and Black and Latina women traveled twice as far as White and Asian women for treatment.

Low-wage people of color, who already have the least access to fertility care, are the same people who have the least access to abortion care.

That limited access is now under siege on both ends, said reproductive endocrinologists and IVF experts, if treatments become more costly.

Patients with the means to do so may move to states with more expansive laws for IVF, and doctors in states that might restrict IVF will move to states where they can continue to practice, said Dr. Lora Shahine, a reproductive endocrinologist at Pacific NW Fertility in Seattle and host of the Baby or Bust Podcast. That will result in further limiting access to patients, particularly in states in the South where the majority of low-wage women of color are concentrated and where most of these personhood bills have been introduced.

Dr. Robert K. Hunter II, the practice director at Kentucky Fertility Institute in Louisville, said the fear of losing his job and having to potentially move to another state is very real for him. Kentucky has tried to pass a personhood bill in the past, and its one of 13 states with a trigger law that would ban abortion immediately if Roe is overturned.

If doctors are limited in the number of eggs they can fertilize, whether or not they can perform genetic testing or whether they can cryopreserve eggs the same limitations Italy imposed that could increase the number of IVF cycles patients have to undergo to have a successful pregnancy, and it can increase risk for doctors, he said.

The cost of continuing to do business will increase for providers, and that will absolutely get passed down to patients, Hunter said. And not to mention if we cant do genetic testing and cryopreservation thats a lot of added cost and disappointment and emotional cost with that, as well.

Hunter said that if that happened, he would become only one piece in a complex IVF process that could see patients seeking care in multiple states.

For me to become someone that is just making embryos to ship them to Illinois or wherever the closest women-friendly state is Is that a sustainable business for me? If I just become a monitoring center for a practice that can still perform IVF for another state? I dont know that thats a viable practice model for me, he said. I dont know what is coming down the pike. I will certainly do my best to fight for my patients, but at the same time, in all my years of medical school, residency training, fellowship training, I never thought Id be affected. That wasnt part of the gig.

IVF is still protected, doctors stressed, but they have also started to think about what could happen in a world where its not.

In Nebraska, Dr. Stephanie Gustin knows it could become a reality. In April, the state tried to pass an abortion bill that redefined life as beginning at fertilization. It lost by two votes. Republican Gov. Pete Ricketts has indicated that if Roe v. Wade is overturned, he will call a special session this summer to reintroduce the legislation. Gustin is part of a coalition of doctors working to inform legislators about the implications such a bill would have for fertility care.

Gustin, who is the medical director of the Heartland Center for Reproductive Medicine in Omaha, one of only two fertility clinics in the state, is conflicted about what to do if it passes.

I made this promise to do no harm. Why would I provide my patient with substandard care that, if they could drive to Colorado or Minnesota they could get the standard care of IVF, just to keep my business alive? I wouldnt be able to sleep at night, Gustin said. The problem is that by not having a fertility clinic here, there will be many people who cant seek IVF care, period. Those people may be like, We would rather have something than nothing. She hasnt yet figured out how she would navigate that.

Programs that provide grants and loans to families seeking IVF treatment are also teasing out how it could impact them and the people they serve. Many of those programs were born of former IVF patients who have faced the challenges of cost firsthand.

Teresa Barbosa, the CEO of Gift of Parenthood, a program that awards quarterly IVF grants to families in financial need, said she created the program in 2019 after spending more than $60,000 her life savings on ultimately unsuccessful IVF treatments.

Gift of Parenthood awards grants as high as $20,000 four times a year; more than 15 babies have been born as a result of the treatments they helped facilitate. Many of those who come seeking help are women of color, like her, who are running out of options, Barbosa said.

They dont have the access its really scary, she said. Gift of Parenthood this year added a fundraising feature on its site to help families raise funds for their procedures, as well as a response to the degree of need.

She feels in limbo, Barbosa said, facing the possibility that even more people will need help paying for IVF and she will be able to help an even smaller slice.

Fertility loan providers like EggFund, which helps streamline the application process for IVF patients, already makes accessing loans easier for patients through one application that ensures the money goes to them and not a clinic. That could help in the case that a clinic closes in a state with changing IVF laws, said founder Carmela Rea. EggFund also allows participants to apply with other people, including siblings and parents, to help reach the requirements for a loan. But higher IVF costs will likely mean higher loans and more debt.

Rea created EggFund in 2017 after spending $80,000 of her savings on her own IVF treatments.

I felt it was wrong that only the wealthy could procreate, and I think its a human right if you want to have a family to be able to have it and not to have money be the consideration that decides whether you can have a family if you want it or whether you can end a pregnancy if you dont want it, Rea said. It shouldnt come down to your wealth.

Already insurance coverage for IVF is limited at best and nonexistent at worst. Few employers cover it, and those that do are typically larger companies that employ higher-paid workers, like major tech companies.

At the Baby Quest Foundation, one of the most well-known IVF grant programs in the country, founder Pamela Hirsch said she is working to get more employers to cover IVF. Hirsch has helped give 200 grants since launching in 2012 after her own daughter underwent four unsuccessful IVF cycles before welcoming two babies via surrogates.

Abortion restrictions could make it less likely for employers to include IVF coverage in their insurance plans, experts said.

Its almost like a collision course: Which direction is fertility moving in? More access to care because people will be lucky to have insurance coverage from their work or the whole industry closing down? Hirsch said.

Currently, New York requires that large-group insurance policies cover three rounds of IVF. That law leaves out Medicaid patients and those who work for employers with fewer than 100 employees, an estimated 2 million New Yorkers, said Risa Levine, an infertility advocate and former member of the board of directors at RESOLVE: The National Infertility Association, who helped pass the legislation in New York.

She spent $270,000 on fertility treatments.

As a White Jewish woman whose parents wanted her to have a kid, I was able to borrow money from my parents, Levine said. But, it absolutely impacted my financial security. It put me in a precarious financial situation.

Low-income women wouldnt even have that choice, she said. And insurance providers are going to reflect the new risk brought on by changes that redefine how IVF can be performed.

What insurance company is going to cover a clinic and a doctor for malpractice or for criminal behavior if they define life as beginning at conception outside of the womb? Levine said.

For providers, the entire discussion puts into question all the advancements IVF has made scientifically and politically in recent years.

There are numerous questions and few answers. What will happen to the pace of scientific discovery if fertility clinics close and IVF becomes a niche service? What will happen to patients, if companies are less willing to cover IVF and conversations about insurance covering the procedure die out?

We are so far from one another, Shahine said, and I feel like any restrictions are going to make those gains weve already made fall backward.

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Many low-income people are already shut out of IVF. Could abortion bans make it even more expensive? - The 19th*

With a history of breast cancer in her family, Andrea Cronin has been careful to get annual mammograms since she was in her early 30s.

Like a lot of women, though, she skipped the test in 2020 due to the pandemic. She was relieved when her 2021 test came back negative, but she wanted more reassurance. Cronins mother was diagnosed with breast cancer 28 years ago, and the cancer has since metastasized to her stomach and bones. Cronin also has dense breasts, which can make reading a mammogram more difficult.

With my mothers history, I just wanted to be proactive, recalled Cronin, 47, who is from Haddonfield. My doctor suggested alternating mammograms and MRIs every six months.

This past January, Cronins MRI showed a tumor, which was confirmed by an ultrasound. She was diagnosed with stage II invasive ductal carcinoma.

Cronins hunch that she needed further testing paid off. Not waiting another year to find the cancer means her prognosis is good, said Zonera Ali, Cronins oncologist at the Lankenau Institute for Medical Research.

But her situation is unusual, her doctor and experts stressed.

Most patients cancers are picked up on the mammogram, but about twice a year I see a patient whose cancer is found through the MRI, said Ali. When cancers are detected earlier, chances of cure are much higher.

For Cronin, getting additional testing made sense, given her mothers bouts with breast cancer. But that is not advised for women without a family history of cancer. The increased sensitivity that MRIs offer can show something that looks like a problem but may not actually be a problem, said Richard Bleicher, leader of the Breast Cancer Program and professor of surgical oncology at Fox Chase Cancer Center.

MRIs can result in three times more unnecessary biopsies than mammograms, he noted.

We end up doing a lot of biopsies, more testing and interval testing, and sometimes unnecessary surgeries that cause pain and discomfort for women, not to mention costs and anxiety, he said.

When Cronins cancer was detected, she was given the option of having a lumpectomy, in which just the lump and surrounding tissue would be removed, but opted to have both breasts removed in a double mastectomy, given her mothers history of recurrence.

This would require only one surgery and get me back into my life of dentistry quicker, Cronin said.

Her mother, Joyce Makarczyk, was first diagnosed with breast cancer through a routine mammogram in 1993, at the age of 46.

I was going to go for a second opinion but the doctor said it was an aggressive cancer so I shouldnt waste any time, recalled Makarczyk, who lives in Mays Landing. Cancer was also discovered in her lymph nodes, so she had one breast removed, followed by chemotherapy and radiation.

About 10 years later, the cancer returned in her right breast. She had a lumpectomy and radiation and was cancer-free for five years. But then she started having stomach problems. The cancer had metastasized into her stomach and bones.

READ MORE: Maria Quiones-Snchez went public after being diagnosed with breast cancer. Now she begins the next chapter of her story. | Helen Ubias

Makarczyk, now 75, has taken the targeted therapy Ibrance ever since and has PET scans every six months. A couple of times, the scan showed cancer cells in her stomach, which were surgically removed.

Im feeling OK, she said. The cancer doesnt cause me any trouble at all.

During Cronins double mastectomy in March, cancer was found in one of the 11 lymph nodes tested. In late April, she started eight sessions of chemotherapy over four months, which will be followed by one month of radiation.

Once cancer escapes into the lymph nodes, the chance of that cancer going somewhere else is higher, said Ali. Especially in women below the age of 50, we recommend chemotherapy and post-mastectomy radiation.

After Cronins cancer diagnosis, her older sister Erica Toffenetti also is seeking additional screening.

The fact that my sister showed no symptoms, it wouldnt hurt to have these tests done for a baseline, said Toffenetti, 51, from Buena, N.J. Im feeling a little nervous but also more relieved. With my mother Ive been dealing with breast cancer more than half my life.

Toffenetti, who has two children, had genetic testing done in 2012 and again in 2019 as the testing became more advanced. Like her sister, she doesnt have the BRCA gene associated with higher risks of cancer.

Both sisters have dense breasts, as do nearly half of all women age 40 and older who get mammograms, according to the NIH. Dense breasts have relatively high amounts of glandular tissue and fibrous connective tissue, which make it more difficult to see potential tumors.

The American Cancer Society recommends mammograms as a choice for women aged 40 to 44. Women aged 45 to 54 should get a mammogram every year; and women 55 and older should switch to a mammogram every two years, or can continue yearly screening.

At this time, experts do not agree what other tests, if any, should be conducted in addition to mammograms in women with dense breasts, according to the American Cancer Society website.

ACS recommends mammograms for dense breasts without any other high-risk factors, said Karen E. Knudsen, chief executive officer of the American Cancer Society and former enterprise director of the Sidney Kimmel Cancer Center at Jefferson Health.

When Renee Anderson, Cronins ob/gyn at Pennsylvania Hospital, sends mammogram results to patients with dense breasts, she includes an explanation of what it means.

In those cases, Anderson gives her patients the option for more testing, and about half, most often those with a family history of cancer, choose to have an MRI or ultrasound.

When you get a discrepancy like what you have with Andrea, it could have been missed because of dense breasts, she said. Or whats more worrisome is that you could have a very aggressive form of cancer that started quickly and is growing quickly.

READ MORE: The war on cancer at 50: How a socialite citizen-lobbyist started a movement

Cronin, whose cancer is slow growing, was fortunate that her insurance covered the MRI. Thats not the case for every woman. In 2020, Pennsylvania Gov. Tom Wolf signed into law legislation requiring insurers to cover breast MRIs or ultrasounds for women at increased risk of breast cancer. But the patient still may be responsible for co-pays and deductibles, which can be costly.

Anderson stressed that the most important form of self-care is seeing your gynecologist and having a mammogram annually, especially for older women. The ACS guidelines say screening should continue as long as a woman is in good health and is expected to live 10 more years or longer.

For some women as they get older, 50 and above, they dont think they need to come to a gynecologist, so nobody is doing an exam, she said.

Breast cancer is associated with the BRCA1 and BRCA2 genes, but just 0.25% of the general population who have breast cancer have the BRCA gene, said Ali, Cronins oncologist. That number jumps to 2.5% among Ashkenazi Jewish women.

With an 11-year-old daughter, Cronin was eager to have genetic testing. She was tested for 35 different genes related to an increased risk for certain cancers and was negative for all of them, including the BRCA genes.

Unfortunately, I feel that I still have to worry about her, because I dont have the gene but still got cancer, she said.

Cronin shared her experience in an email to her dental patients, alerting them to the fine print disclaimer at the bottom of some mammogram reports that says extreme breast density decreases the sensitivity of mammograms. Please discuss family history and any concerns with your provider.

So many patients have thanked me directly for being so transparent with them, Cronin said. Specifically, two patients told me that after sharing my emails, their mothers demanded more testing after first being told no. Its so important to be your own patient advocate.

Visit link:
An MRI detected breast cancer in this Haddonfield woman. Should you consider having one? - The Philadelphia Inquirer

Four years ago, Annik Greenhill discovered she had an inherited mutation of the BRCA1 gene, which predisposes her to breast cancer.

While discovering the gene potentially saved her life, it led to challenges with insurance that have left her in a difficult position.

Insurance companies were concerned the BRCA1 gene made her high risk, and she had to be on a premium health insurance plan to be covered, she said.

In New Zealand insurance companies are allowed to ask to see the results of genetic tests, which has led to accusations of discrimination.

READ MORE:* Beware of DNA health tests by ancestry companies* Preventative double mastectomy worth it for mum-of-two living with the BRCA gene mutation* I tried to ignore genetic warnings about cancer, and that could have been fatal

After returning to New Zealand, Greenhill struggled to find an insurance company willing to cover the gene. Her insurance broker told her most insurers would exclude any treatment relating to the gene, or only cover her after prophylactic surgeries were undertaken.

Abigail Dougherty/Stuff

Annik Greenhill is a BRCA1 carrier and has been affected by genetic discrimination as a result.

I thought the fact I know I am a carrier should in some ways reduce my overall risk to an insurance company because I am in an early detection programme, I was a carrier whether I knew it or not.

Breast Cancer Foundation NZ chief executive Ah-Leen Rayner said insurance discrimination around the BRCA gene was a serious problem, and a law change was needed.

So long as New Zealand insurers are able to ask about genetic test result, people with the BRCA gene will be discriminated against, even though they might not get breast cancer.

Greenhill eventually took out an UltraCare policy with Southern Cross, the only insurer who would offer coverage related to the gene, she said.

However, had to be on the second-highest plan, and only after a three-year stand down period would she be eligible for BRCA related covershe said.

Health insurance cost the family $580 a month, a significant expense, she said.

Southern Cross said that it would cover cancer treatment without a stand down period. But because she already knew she had BRCA1, she would not be covered for monitoring the gene or for prophylactic treatment for three years.

She also applied for additional chemotherapy cover of $300,000 a year, but was capped at $60,000.

Southern Cross said while Greenhill would not be excluded from taking out a Chemo 300 plan, she would need to meet the terms and conditions, which included possible exclusions for family history.

ROSA WOODS/STUFF

Ashleigh Stallard has the BRCA gene and was faced with a strong risk of developing breast cancer. She chose to have a preventive mastectomy at age 23. (Video first published in October 2019)

While grateful Southern Cross offered some cover, she said it still felt like she was being punished for gaining a better understanding of her health.

Greenhill did not regret her decision to get tested, but was concerned others in her position would be discouraged because of the genetic discrimination she encountered.

Its a conundrum that Georgia Eve, a 22-year-old social support worker, is grappling with.

She was planning to donate one of her eggs to a fertility organisation, until she heard it could lead to genetic discrimination from insurers.

Egg donors are required to take a genetic test as part of predonation health checks. But potential donors are told the results of that test can be legally asked for and used by insurers in underwriting decisions.

Despite having wanted to donate an egg for some time, the potential for genetic discrimination in later life was a dealbreaker, Eve said.

Its a bit of a risk to take. I am someone who wants to travel, so I am concerned about affording access to travel insurance later in life. I am thinking it might be better not to do it, she said.

Eve said insurers position on genetic testing was affecting broader public health.

If people are being dissuaded by insurance companies not to get genetic testing, they are losing an opportunity to live healthier lives. But as it stands many people are choosing not to know.

Abigail Dougherty/Stuff

Georgia Eve had been considering donating an egg to a fertility service. But to do so she would have had to undergo a genetic test, and in New Zealand an insurance company can ask to see the results.

A United States survey found 28% of participants declined genomic testing because of concerns about insurance discrimination, the New Zealand Medical Journal reported recently.

But Australia and Canada are legislating to protect individuals from genetic discrimination by insurance companies.

Canada, in 2017, introduced a complete ban on the use of genetic test results to discriminate, including for insurance and employment.

The Australian life insurance industry, in 2019, introduced a five-year ban on the use of genetic tests in underwriting.

New Zealand insurance companies have not followed suit.

Auckland University Centre for Cancer Research acting director Professor Andrew Shelling said New Zealand was a significant disparity from other first-world countries in the way it handled genetic information.

People should be very concerned about insurers using genomic information, and the patient advocacy group Against Genetic Discrimination Aotearoa, was calling for a complete ban, Shelling said.

Genetic testing allowed people to make informed health care decisions, and people were refusing to undergo testing because of the potential insurance consequences, he said.

For people who are at risk of genetic conditions, choosing not to be tested may have serious health impacts.

While there was no New Zealand data to draw from, he believed it would be similar to the rest of the world, where between 10% and 30% of people were declining testing.

Thats an extraordinary number of people and is likely to be having a significant impact on people at risk of serious genetic disease.

Southern Cross chief sales and marketing officer Kerry Boielle said it did not add a pre-existing condition exclusion as a result of a genetic abnormality, and typically would not increase premiums or refuse to issue a policy based on that information.

However, it may exclude any consultations, further tests, or treatment required in its policy as a result of an abnormality.

Southern Cross said that in the past five years, 51 members had disclosed a genetic abnormality or mutation, and 51 people had exclusions applied to their policy as a result of genetic abnormalities.

Three other insurance companies said they were members of the Financial Services Council (FSC) and complied with the councils code of conduct and guidelines around genetic tests.

FSC chief executive Richard Klipin said the issue of genetic testing was complex.

To ensure that insurance remains sustainable and fair for all customers, some insurers may ask customers to disclose known information about the results of their genetic tests, Kiplin said.

But, insurers were never asked to carry out genetic testing, he said.

CORRECTION: An earlier version of this article stated Southern Cross required a stand down period of three years before it would cover cancer related to the BRCA1 gene. However, the stand down period relates to prophylactic treatment. (Amended at 12.54pm on June 8, 2022)

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Kiwis should be 'very concerned' about genetic discrimination - Stuff

Case Overview:

Initial Presentation (Jan 2017)

A 64-year-old man is found to have a firm bilateral prostate nodule of 1.8 mm on his routine physical exam

Clinical workup

PSA 109.1 ng/mL

Family history of prostate cancer (father, uncle)

Transrectal ultrasound (TRUS)-guided biopsy of the prostate confirms advanced adenocarcinoma of the prostate and Gleason score of 8 (4 + 4)/Grade Group 4

MRI is negative for pelvic LN involvement but positive for one 1.1-cm mediastinal supraclavicular LN (T2bN0M1a)

His ECOG PS is 1

Germline multigene testing of biopsy specimen revealed a BRCA2 mutation

Initial Treatment (starting Feb 2017)

Patient was started on leuprolide and abiraterone; scheduled for physical exam, PSA assessment, and imaging every 3 months.

By the second follow-up visit (6 months after initiating treatment; August 2017), PSA levels declined to 2.1 ng/mL and prostate nodule size was 1.4 mm.

Patients disease remained stable through August 2018 (18 months of treatment).

21- and 24-month Follow-up Notes (November 2018, February 2019)

Patients PSA levels increased to 46.9 ng/mL in 11/2018 and 73.7 ng/mL in 2/2019.

MRI revealed that the size of the existing positive LN increased to 1.3 cm, and revealed a new, faintly positive 0.9-cm para-aortic LN.

Given the recent findings and the patients known BRCA2 mutation status, the patient and clinician decide to initiate olaparib 300 mg BID.

Neal Shore, MD, FACS: Lets review the utility of genetic testing in patients with prostate cancer. This is a really important topic. Lets talk about the guidelines for testing. I think most would agree that the NCCN [National Comprehensive Cancer Network] has done a good job in evolving their recommendations for both germline and somatic testing. Right now, in 2022, its really not who do you test, whos newly diagnosed, its who dont you test for germline alterations. The answer is, if youre in grade group 1 or grade group 2, so Gleason score 6, or 3 plus 4, and you have no significant family history of cancer, the NCCN says dont get germline testing. Everyone else, grade group 1 and 2 with a significant family history of cancerbreast, ovarian, colorectal, prostate, male breast, upper tract, urothelial, melanoma, skin cancer, pancreatic canceryou would get germline testing. Certainly, anybody whos high-risk localized, you get germline testing. And anyone who has metastatic disease, de novo or recurrent, you get germline testing.

We presented some data, we had a podium presentation of 1000 patients studied prospectively. We presented it at ASCO [American Society of Clinical Oncology annual meeting] 2021 and at AUA [American Urological Association meeting] 2021. We basically came to the conclusion that we think all patients should be tested regardless of their grade group or their family history, because oftentimes family history is not reliable. Its important to get when it is reliable, but it can be unreliable. And some patients and their caregivers and their partners just dont know their family history. Some people are adopted. Then theres always the chance that the histopathology report can have variable or different interpretations, so a 3 plus 4 might actually be a 4 plus 3. I even see second opinions where a 3 plus 3 has turned into a 4 plus 3. Or a 3 plus 4 can become a 4 plus 4. Im a believer in democratizing germline testing to make it simpler. Its gotten less expensive. Thats subjective, but it used to be in the thousands-of-dollars range. Now its only a few hundred dollars, so I think anyone diagnosed with localized prostate cancer, my personal opinion is they should get germline testing.

Now, somatic testing per the NCCN recommendation is to get it when you are resistant, so when you are castration resistant. Its important because if youre germline negative, you might pick up another 50% of patients with HRR [homologous recombination repair] mutations. We saw that about 28%, 30% in some centers have HRR mutations, and we saw that in the PROfound trial. Other trials and studies have corroborated that. For newly diagnosed, youre probably going to see positive germline alterations in the HRR category of about 10% to 12%. So its important if youre germline negative that you dont stop there once the patient develops resistance, that you get either the archival tissue, prostate biopsy tissue, the prostatectomy specimen. Or you can get metastasis-directed biopsies. If you cant get tissue or you cant do a biopsy, then you can what we describe as a liquid biopsy, and you look for circulating DNA alterations.

This then opens up a field of opportunity of clinical utility because we now have level 1 evidence for the use of PARP inhibitors. We also have level 1 evidence for the use of a checkpoint inhibitor when theres MSI [microsatellite instability]-high. We also have multiple trials ongoing with other alterations, such as ATM, PTEN loss, other alterations where were looking in a clinical trial landscape to come up with additional therapeutics. Then theres the importance of cascade family testing. If theres a germline alteration, youd want to certainly know to inform the patients children, siblings, nieces and nephews. It would be great to be able to pick up a very early ovarian, breast or prostate cancer, pancreatic cancer, colorectal cancer, and cure that patient at its earliest stages.

How do the test results impact patient management? Well, exactly, if you have an alteration, its a pathogenic variant as opposed to a variant of uncertain significance. It can lead to approved therapies as Ive described. It could lead to more vigilant surveillance or possibly an active intervention for localized disease. Or it certainly could lead to an approved indication of a therapy when the patient reaches that point in their journey.

Transcript edited for clarity.

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The Utility of Genetic Testing in Patients with Prostate Cancer - Urology Times

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Prenatal TestingNew Born ScreeningPredictive and Presymptomatic TestingPharmacogenomic TestingOthers

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Genetic Testing Services Market Size 2022 With 5.99% CAGR : Recent Industry Developments With Top Players and Forecast Up to 2031 - Taiwan News

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Key Players Mentioned in the Global Preimplantation Genetic Testing for Aneuploidy Kits Market Research Report: PerkinElmerIlluminaThermo Fisher ScientificBASECAREPeking Jabrehoo Med Tech

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Table of Content

1 Preimplantation Genetic Testing for Aneuploidy Kits Market Overview1.1 Preimplantation Genetic Testing for Aneuploidy Kits Product Overview1.2 Preimplantation Genetic Testing for Aneuploidy Kits Market Segment by Type1.2.1 Reversible End Termination Sequencing1.2.2 Iron Semiconductor Sequencing1.3 Global Preimplantation Genetic Testing for Aneuploidy Kits Market Size by Type1.3.1 Global Preimplantation Genetic Testing for Aneuploidy Kits Market Size Overview by Type (2017-2028)1.3.2 Global Preimplantation Genetic Testing for Aneuploidy Kits Historic Market Size Review by Type (2017-2022)1.3.2.1 Global Preimplantation Genetic Testing for Aneuploidy Kits Sales Breakdown in Volume by Type (2017-2022)1.3.2.2 Global Preimplantation Genetic Testing for Aneuploidy Kits Sales Breakdown in Value by Type (2017-2022)1.3.2.3 Global Preimplantation Genetic Testing for Aneuploidy Kits Average Selling Price (ASP) by Type (2017-2022)1.3.3 Global Preimplantation Genetic Testing for Aneuploidy Kits Forecasted Market Size by Type (2023-2028)1.3.3.1 Global Preimplantation Genetic Testing for Aneuploidy Kits Sales Breakdown in Volume by Type (2023-2028)1.3.3.2 Global Preimplantation Genetic Testing for Aneuploidy Kits Sales Breakdown in Value by Type (2023-2028)1.3.3.3 Global Preimplantation Genetic Testing for Aneuploidy Kits Average Selling Price (ASP) by Type (2023-2028)1.4 Key Regions Market Size Segment by Type1.4.1 North America Preimplantation Genetic Testing for Aneuploidy Kits Sales Breakdown by Type (2017-2022)1.4.2 Europe Preimplantation Genetic Testing for Aneuploidy Kits Sales Breakdown by Type (2017-2022)1.4.3 Asia-Pacific Preimplantation Genetic Testing for Aneuploidy Kits Sales Breakdown by Type (2017-2022)1.4.4 Latin America Preimplantation Genetic Testing for Aneuploidy Kits Sales Breakdown by Type (2017-2022)1.4.5 Middle East and Africa Preimplantation Genetic Testing for Aneuploidy Kits Sales Breakdown by Type (2017-2022)2 Global Preimplantation Genetic Testing for Aneuploidy Kits Market Competition by Company2.1 Global Top Players by Preimplantation Genetic Testing for Aneuploidy Kits Sales (2017-2022)2.2 Global Top Players by Preimplantation Genetic Testing for Aneuploidy Kits Revenue (2017-2022)2.3 Global Top Players Preimplantation Genetic Testing for Aneuploidy Kits Price (2017-2022)2.4 Global Top Manufacturers Preimplantation Genetic Testing for Aneuploidy Kits Manufacturing Base Distribution, Sales Area, Product Type2.5 Preimplantation Genetic Testing for Aneuploidy Kits Market Competitive Situation and Trends2.5.1 Preimplantation Genetic Testing for Aneuploidy Kits Market Concentration Rate (2017-2022)2.5.2 Global 5 and 10 Largest Manufacturers by Preimplantation Genetic Testing for Aneuploidy Kits Sales and Revenue in 20212.6 Global Top Manufacturers by Company Type (Tier 1, Tier 2 and Tier 3) & (based on the Revenue in Preimplantation Genetic Testing for Aneuploidy Kits as of 2021)2.7 Date of Key Manufacturers Enter into Preimplantation Genetic Testing for Aneuploidy Kits Market2.8 Key Manufacturers Preimplantation Genetic Testing for Aneuploidy Kits Product Offered2.9 Mergers & Acquisitions, Expansion3 Preimplantation Genetic Testing for Aneuploidy Kits Status and Outlook by Region3.1 Global Preimplantation Genetic Testing for Aneuploidy Kits Market Size and CAGR by Region: 2017 VS 2021 VS 20283.2 Global Preimplantation Genetic Testing for Aneuploidy Kits Historic Market Size by Region3.2.1 Global Preimplantation Genetic Testing for Aneuploidy Kits Sales in Volume by Region (2017-2022)3.2.2 Global Preimplantation Genetic Testing for Aneuploidy Kits Sales in Value by Region (2017-2022)3.2.3 Global Preimplantation Genetic Testing for Aneuploidy Kits Sales (Volume & Value) Price and Gross Margin (2017-2022)3.3 Global Preimplantation Genetic Testing for Aneuploidy Kits Forecasted Market Size by Region3.3.1 Global Preimplantation Genetic Testing for Aneuploidy Kits Sales in Volume by Region (2023-2028)3.3.2 Global Preimplantation Genetic Testing for Aneuploidy Kits Sales in Value by Region (2023-2028)3.3.3 Global Preimplantation Genetic Testing for Aneuploidy Kits Sales (Volume & Value), Price and Gross Margin (2023-2028)4 Global Preimplantation Genetic Testing for Aneuploidy Kits by Application4.1 Preimplantation Genetic Testing for Aneuploidy Kits Market Segment by Application4.1.1 Public Hospital4.1.2 Private Hospital4.2 Global Preimplantation Genetic Testing for Aneuploidy Kits Market Size by Application4.2.1 Global Preimplantation Genetic Testing for Aneuploidy Kits Market Size Overview by Application (2017-2028)4.2.2 Global Preimplantation Genetic Testing for Aneuploidy Kits Historic Market Size Review by Application (2017-2022)4.2.2.1 Global Preimplantation Genetic Testing for Aneuploidy Kits Sales Breakdown in Volume, by Application (2017-2022)4.2.2.2 Global Preimplantation Genetic Testing for Aneuploidy Kits Sales Breakdown in Value, by Application (2017-2022)4.2.2.3 Global Preimplantation Genetic Testing for Aneuploidy Kits Average Selling Price (ASP) by Application (2017-2022)4.2.3 Global Preimplantation Genetic Testing for Aneuploidy Kits Forecasted Market Size by Application (2023-2028)4.2.3.1 Global Preimplantation Genetic Testing for Aneuploidy Kits Sales Breakdown in Volume, by Application (2023-2028)4.2.3.2 Global Preimplantation Genetic Testing for Aneuploidy Kits Sales Breakdown in Value, by Application (2023-2028)4.2.3.3 Global Preimplantation Genetic Testing for Aneuploidy Kits Average Selling Price (ASP) by Application (2023-2028)4.3 Key Regions Market Size Segment by Application4.3.1 North America Preimplantation Genetic Testing for Aneuploidy Kits Sales Breakdown by Application (2017-2022)4.3.2 Europe Preimplantation Genetic Testing for Aneuploidy Kits Sales Breakdown by Application (2017-2022)4.3.3 Asia-Pacific Preimplantation Genetic Testing for Aneuploidy Kits Sales Breakdown by Application (2017-2022)4.3.4 Latin America Preimplantation Genetic Testing for Aneuploidy Kits Sales Breakdown by Application (2017-2022)4.3.5 Middle East and Africa Preimplantation Genetic Testing for Aneuploidy Kits Sales Breakdown by Application (2017-2022)5 North America Preimplantation Genetic Testing for Aneuploidy Kits by Country5.1 North America Preimplantation Genetic Testing for Aneuploidy Kits Historic Market Size by Country5.1.1 North America Preimplantation Genetic Testing for Aneuploidy Kits Sales in Volume by Country (2017-2022)5.1.2 North America Preimplantation Genetic Testing for Aneuploidy Kits Sales in Value by Country (2017-2022)5.2 North America Preimplantation Genetic Testing for Aneuploidy Kits Forecasted Market Size by Country5.2.1 North America Preimplantation Genetic Testing for Aneuploidy Kits Sales in Volume by Country (2023-2028)5.2.2 North America Preimplantation Genetic Testing for Aneuploidy Kits Sales in Value by Country (2023-2028)6 Europe Preimplantation Genetic Testing for Aneuploidy Kits by Country6.1 Europe Preimplantation Genetic Testing for Aneuploidy Kits Historic Market Size by Country6.1.1 Europe Preimplantation Genetic Testing for Aneuploidy Kits Sales in Volume by Country (2017-2022)6.1.2 Europe Preimplantation Genetic Testing for Aneuploidy Kits Sales in Value by Country (2017-2022)6.2 Europe Preimplantation Genetic Testing for Aneuploidy Kits Forecasted Market Size by Country6.2.1 Europe Preimplantation Genetic Testing for Aneuploidy Kits Sales in Volume by Country (2023-2028)6.2.2 Europe Preimplantation Genetic Testing for Aneuploidy Kits Sales in Value by Country (2023-2028)7 Asia-Pacific Preimplantation Genetic Testing for Aneuploidy Kits by Region7.1 Asia-Pacific Preimplantation Genetic Testing for Aneuploidy Kits Historic Market Size by Region7.1.1 Asia-Pacific Preimplantation Genetic Testing for Aneuploidy Kits Sales in Volume by Region (2017-2022)7.1.2 Asia-Pacific Preimplantation Genetic Testing for Aneuploidy Kits Sales in Value by Region (2017-2022)7.2 Asia-Pacific Preimplantation Genetic Testing for Aneuploidy Kits Forecasted Market Size by Region7.2.1 Asia-Pacific Preimplantation Genetic Testing for Aneuploidy Kits Sales in Volume by Region (2023-2028)7.2.2 Asia-Pacific Preimplantation Genetic Testing for Aneuploidy Kits Sales in Value by Region (2023-2028)8 Latin America Preimplantation Genetic Testing for Aneuploidy Kits by Country8.1 Latin America Preimplantation Genetic Testing for Aneuploidy Kits Historic Market Size by Country8.1.1 Latin America Preimplantation Genetic Testing for Aneuploidy Kits Sales in Volume by Country (2017-2022)8.1.2 Latin America Preimplantation Genetic Testing for Aneuploidy Kits Sales in Value by Country (2017-2022)8.2 Latin America Preimplantation Genetic Testing for Aneuploidy Kits Forecasted Market Size by Country8.2.1 Latin America Preimplantation Genetic Testing for Aneuploidy Kits Sales in Volume by Country (2023-2028)8.2.2 Latin America Preimplantation Genetic Testing for Aneuploidy Kits Sales in Value by Country (2023-2028)9 Middle East and Africa Preimplantation Genetic Testing for Aneuploidy Kits by Country9.1 Middle East and Africa Preimplantation Genetic Testing for Aneuploidy Kits Historic Market Size by Country9.1.1 Middle East and Africa Preimplantation Genetic Testing for Aneuploidy Kits Sales in Volume by Country (2017-2022)9.1.2 Middle East and Africa Preimplantation Genetic Testing for Aneuploidy Kits Sales in Value by Country (2017-2022)9.2 Middle East and Africa Preimplantation Genetic Testing for Aneuploidy Kits Forecasted Market Size by Country9.2.1 Middle East and Africa Preimplantation Genetic Testing for Aneuploidy Kits Sales in Volume by Country (2023-2028)9.2.2 Middle East and Africa Preimplantation Genetic Testing for Aneuploidy Kits Sales in Value by Country (2023-2028)10 Company Profiles and Key Figures in Preimplantation Genetic Testing for Aneuploidy Kits Business10.1 PerkinElmer10.1.1 PerkinElmer Corporation Information10.1.2 PerkinElmer Introduction and Business Overview10.1.3 PerkinElmer Preimplantation Genetic Testing for Aneuploidy Kits Sales, Revenue and Gross Margin (2017-2022)10.1.4 PerkinElmer Preimplantation Genetic Testing for Aneuploidy Kits Products Offered10.1.5 PerkinElmer Recent Development10.2 Illumina10.2.1 Illumina Corporation Information10.2.2 Illumina Introduction and Business Overview10.2.3 Illumina Preimplantation Genetic Testing for Aneuploidy Kits Sales, Revenue and Gross Margin (2017-2022)10.2.4 Illumina Preimplantation Genetic Testing for Aneuploidy Kits Products Offered10.2.5 Illumina Recent Development10.3 Thermo Fisher Scientific10.3.1 Thermo Fisher Scientific Corporation Information10.3.2 Thermo Fisher Scientific Introduction and Business Overview10.3.3 Thermo Fisher Scientific Preimplantation Genetic Testing for Aneuploidy Kits Sales, Revenue and Gross Margin (2017-2022)10.3.4 Thermo Fisher Scientific Preimplantation Genetic Testing for Aneuploidy Kits Products Offered10.3.5 Thermo Fisher Scientific Recent Development10.4 BASECARE10.4.1 BASECARE Corporation Information10.4.2 BASECARE Introduction and Business Overview10.4.3 BASECARE Preimplantation Genetic Testing for Aneuploidy Kits Sales, Revenue and Gross Margin (2017-2022)10.4.4 BASECARE Preimplantation Genetic Testing for Aneuploidy Kits Products Offered10.4.5 BASECARE Recent Development10.5 Peking Jabrehoo Med Tech10.5.1 Peking Jabrehoo Med Tech Corporation Information10.5.2 Peking Jabrehoo Med Tech Introduction and Business Overview10.5.3 Peking Jabrehoo Med Tech Preimplantation Genetic Testing for Aneuploidy Kits Sales, Revenue and Gross Margin (2017-2022)10.5.4 Peking Jabrehoo Med Tech Preimplantation Genetic Testing for Aneuploidy Kits Products Offered10.5.5 Peking Jabrehoo Med Tech Recent Development11 Upstream, Opportunities, Challenges, Risks and Influences Factors Analysis11.1 Preimplantation Genetic Testing for Aneuploidy Kits Key Raw Materials11.1.1 Key Raw Materials11.1.2 Key Raw Materials Price11.1.3 Raw Materials Key Suppliers11.2 Manufacturing Cost Structure11.2.1 Raw Materials11.2.2 Labor Cost11.2.3 Manufacturing Expenses11.3 Preimplantation Genetic Testing for Aneuploidy Kits Industrial Chain Analysis11.4 Preimplantation Genetic Testing for Aneuploidy Kits Market Dynamics11.4.1 Preimplantation Genetic Testing for Aneuploidy Kits Industry Trends11.4.2 Preimplantation Genetic Testing for Aneuploidy Kits Market Drivers11.4.3 Preimplantation Genetic Testing for Aneuploidy Kits Market Challenges11.4.4 Preimplantation Genetic Testing for Aneuploidy Kits Market Restraints12 Market Strategy Analysis, Distributors12.1 Sales Channel12.2 Preimplantation Genetic Testing for Aneuploidy Kits Distributors12.3 Preimplantation Genetic Testing for Aneuploidy Kits Downstream Customers13 Research Findings and Conclusion14 Appendix14.1 Research Methodology14.1.1 Methodology/Research Approach14.1.1.1 Research Programs/Design14.1.1.2 Market Size Estimation14.1.1.3 Market Breakdown and Data Triangulation14.1.2 Data Source14.1.2.1 Secondary Sources14.1.2.2 Primary Sources14.2 Author Details14.3 Disclaimer

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Preimplantation Genetic Testing for Aneuploidy Kits Market 2022 by industry trends, statistics, key companies Growth and Regional Forecast2028 |...

Quadintel published a new report on the Preimplantation Genetic Testing Market. The research report consists of thorough information about demand, growth, opportunities, challenges, and restraints. In addition, it delivers an in-depth analysis of the structure and possibility of global and regional industries.

Global Preimplantation Genetic Testing Market is valued approximately USD 492.53 million in 2021 and is anticipated to grow with a healthy growth rate of more than 10.0% over the forecast period 2022-2028.

Pre-implantation genetic testing is the method that is used for the genetic analysis of embryos before implantation. It is a significant procedure because of rising cases of genetically imbalanced structures found in newborns and children. This method tests an embryo prior to implants for a particular, acknowledged genetic disorder.

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The increasing number of fertility clinics worldwide, technological advancements in the field of genetic analysis, and the growing public-private investments in the field of preimplantation genetic testing are the primary factors that are augmenting the market growth. In addition, the declining fertility rate, coupled with the rising incidences of chromosomal abnormalities with proceeding maternal age is the further factor that is surging the market demand across the globe. For instance, according to the World Bank, the fertility rate per total birth worldwide was accounted with 2.445 in 2016 and the amount is declined to 2.402 in 2019. Therefore, decreasing fertility rate is anticipated to fuels the preimplantation genetic testing demand, which, in turn, impels the market growth. However, the high procedural cost associated with preimplantation genetic testing and unfavorable government regulations impedes the growth of the market over the forecast period of 2022-2028. Also, growing awareness of assisted reproduction techniques and increasing medical tourism are anticipated to act as a catalyzing factor for the market demand during the estimated years.

The key regions considered for the global Preimplantation Genetic Testing market study include Asia Pacific, North America, Europe, Latin America, and the Rest of the World. North America is the leading region across the world in terms of market share owing to the increasing adoption of genomic techniques and growing need for IVF procedures (with decreasing fertility rates). Whereas, Asia-Pacific is anticipated to exhibit the highest CAGR over the forecast period 2022-2028. Factors such as rising developments in healthcare infrastructure, as well as the rising focus of leading players on emerging markets, would create lucrative growth prospects for the Preimplantation Genetic Testing market across the Asia-Pacific region.

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Major market players included in this report are:

Illumina, Inc.

Thermo Fisher Scientific Inc.

Agilent Technologies, Inc.

PerkinElmer, Inc.

CooperSurgical, Inc.

Beijing Genomics Institute (BGI)

Abbott Laboratories Inc.

Natera, Inc.

Good Start Genetics, Inc.

Yikon Genomics Co., Ltd.

The objective of the study is to define market sizes of different segments & countries in recent years and to forecast the values to the coming eight years. The report is designed to incorporate both qualitative and quantitative aspects of the industry within each of the regions and countries involved in the study. Furthermore, the report also caters the detailed information about the crucial aspects such as driving factors & challenges which will define the future growth of the market. Additionally, the report shall also incorporate available opportunities in micro markets for stakeholders to invest along with the detailed analysis of competitive landscape and product offerings of key players. The detailed segments and sub-segment of the market are explained below:

By Product & Service:

Reagents & Consumables

Instruments

Software & Services

By Technology:

Next Generation Sequencing (NGS)

Polymerase Chain Reaction (PCR)

Fluorescent In-Situ Hybridization (FISH)

Comparative Genomic Hybridization (CGH)

Single Nucleotide Polymorphism (SNP)

By Procedure Type:

Preimplantation Genetic Screening

Preimplantation Genetic Diagnosis

By Application:

Aneuploidy

Structural Chromosomal Abnormalities

Single Gene Disorders

X-linked Disorders

HLA Typing

Gender Identification

By End User:

Maternity Centers & Fertility Clinics

Hospitals, Diagnostic Labs, and Service Providers

Research Laboratories & Academic Institutes

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By Region:

North America

U.S.

Canada

Europe

UK

Germany

France

Spain

Italy

ROE

Asia Pacific

China

India

Japan

Australia

South Korea

RoAPAC

Latin America

Brazil

Mexico

Rest of the World

Furthermore, years considered for the study are as follows:

Historical year 2018, 2019, 2020

Base year 2021

Forecast period 2022 to 2028

Target Audience of the Global Preimplantation Genetic Testing Market in Market Study:

Key Consulting Companies & Advisors

Large, medium-sized, and small enterprises

Venture capitalists

Value-Added Resellers (VARs)

Third-party knowledge providers

Investment bankers

Investors

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Table of Contents:

Factors Influencing

The global market is forecast to witness a rapid growth, owing to increasing demand for technological advancements from end-users. Moreover, increasing investments in research and development activities, launches, partnerships, and other strategic initiatives will benefit the market. Furthermore, the growing focus of authorities towards increasing urbanization and industrialization is forecast to drive the market growth.

What aspects regarding the regional analysis Market are included in this report?

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Preimplantation Genetic Testing Market [RISING TODAY] 2022 Size Analysis by Regions, Share, Industry Growth Statistics and Forecast 2030 - Taiwan News

Pregnancy, in this age of modern medicine, comes with a series of routinely recommended prenatal tests: At 11 weeks, a blood draw and an ultrasound to check for conditions such as Down syndrome. At 15 weeks, another blood test, for anomalies such as spina bifida. At 18 to 22, an ultrasound anatomy scan of the babys heart, brain, lungs, bones, stomach, fingers, and toes. This is when many parents learn if theyre expecting a boy or girlbut the more pressing medical reason is to look for anatomical defects, including severe ones such as missing kidneys or missing parts of the brain and skull.

With Roe v. Wade in place in America, women undergoing prenatal tests have typically had the legal right to end a pregnancy based on the information they learn. But abortion restrictions in certain statesby gestational age or by fetal anomalyhave already started limiting that choice. And if the Supreme Court overturns Roe, as seems likely, it will be further curtailed in some states. Routine parts of prenatal care could start to look quite different in states that ban abortion than in states that allow it.

Even now, laws in more than a dozen states that restrict abortion past 20 weeks are changing the use of the second-trimester anatomy scans. People are moving those tests backward, doing them earlier than is optimal, says Laura Hercher, a genetic counselor at Sarah Lawrence College who recently conducted a survey of genetic counselors in abortion-restrictive states. But the earlier the scan, the less doctors can see. Certain brain structures, such as the cavum septum pellucidum, might not develop until week 20, says Chloe Zera, an obstetrician in Massachusetts. Being unable to find this structure could indicate a brain anomaly, or just that the scan was done too early. Doctors might also pick up evidence of a heart defect but not know how severe or fixable it is. At 20 weeks, the heart is only the size of a dime.

Read: The future of abortion in post-Roe America

Six states also currently restrict abortions on the basis of genetic anomalies. These laws typically target Down syndrome, or trisomy 21, in which the presence of a third chromosome 21 can have a range of physical and mental effects, milder in some children than others. Some states laws specifically mention Down syndrome; others extend the restrictions to a much wider range of genetic anomalies, many far more life-limiting than Down syndrome. In trisomy 13, for example, the physical anomalies are so severe that most babies live only for days or weeks. More than 90 percent do not survive past their first year.

In states that currently restrict abortion based on genetic anomalies but still allow it for other reasons under Roe, patients can get an abortion if they do not mention the genetic anomaly. This puts doctors and genetic counselors in a bind. For instance, says Leilah Zahedi, a maternal-fetal-medicine physician in Tennessee, what if doctors see a severe heart defect on an ultrasound? The underlying cause of many such heart problems is Down syndrome. But Tennessee restricts abortions specifically on the basis of trisomy 21. Should doctors tell patients about the connection to Down syndrome? Should they do the genetic testing? It could help parents prepare for everything else that comes with Down syndrome. But it would make it harder for them to get an abortion, if they chose to have one. They would need to go to a different doctor who does not know about the diagnosis, and take care not to reveal it.

Many of the current abortion restrictions do contain exemptions for cases with the most dramatic medical consequences: a fatal fetal anomaly or risk to the mothers life. If Roe is overturned, many of the trigger laws that will immediately ban abortion in some states contain such exemptions as well. But what is fatal to the baby and what risk is acceptable to the mother are not entirely clear criteria. There are very few bright lines in medicine, says Cara Heuser, a maternal-fetal-medicine physician in Utah. Laws really do not allow for all the nuance we see in medicine. They ignore the uncertainty.

When it comes to fetal anomalies, its very rare we can say, This is universally fatal, Zera told me. For example, in the case of a massive brain hemorrhage that destroys most of the brain tissue but leaves the brain stem intact, the baby can breathe at birth but will need other medical care. Does fatal mean fatal in the absence of certain medical interventions? Which ones? And does an anomaly have to be fatal immediately, or within some period after birth?

Read: When a right becomes a privilege

There is ambiguity in exceptions for the life of the mother, too. A genetic counselor in Texas told me about a recent patient whose fetus was triploid, meaning it had a complete extra set of 23 chromosomes. This is one of the universally lethal conditions. But triploidy also poses an extra risk to the mother, because these pregnancies are linked to preeclampsia, or dangerously high blood pressure. Texas currently restricts abortions past about six weeks except in medical emergencies. High blood pressure may not be an immediate medical emergency, but it can become one. Whats scary about being a person who is pregnant in Texas, says the genetic counselor, whom I agreed not to name because this person feared legal retribution in the state, is that many physicians will wait to provide treatment until moms life is truly in danger. The fetus will not survive, and delaying may only increase the risk to the mother, but we have to wait until you get sick enough to deliver you. These laws create a general climate where doctors who fear prosecution may hesitate to treat the mother. Sometimes, Heuser says, that hesitation can be fatal.

If Roe is overturned and abortion is banned in many states, testing could take on a different role in prenatal care. Zahedi told me, anecdotally, of one recent patient whose doctor told her there wasnt a point to genetic screening anymore. But she doesnt actually think abortion bans will change the use of testing, even if they will limit what patients can do afterward. Most of her patients in Tennessee already do not choose abortion, she said, but the tests can provide information that inform obstetric care and prepare parents for whats to come.

Others brought up the possibility, in the long term, of insurance companies dropping coverage for prenatal tests. Cumulatively, all of these types of screenings and tests are incredibly expensive, Hercher, of Sarah Lawrence, told me. Insurance currently has a financial incentive to cover them because preventing the birth of a child with severe medical needs saves on costs down the line. But if abortion is illegal in many states, Hercher asks, will insurance companies, especially regional ones, want to continue covering these tests? Or will patients have to pay for them out of pocket? These tests are currently routine for pregnant women, but whether they stay that way in the future could depend on where you live and what you can afford.

Read the original post:
How the End of Roe Would Change Prenatal Care - The Atlantic

New Jersey, United States The Pediatric Genetic Testing Market Research Report is a professional asset that provides dynamic and statistical insights into regional and global markets. It includes a comprehensive study of the current scenario to safeguard the trends and prospects of the market. Pediatric Genetic Testing Research reports also track future technologies and developments. Thorough information on new products, and regional and market investments is provided in the report. This Pediatric Genetic Testing research report also scrutinizes all the elements businesses need to get unbiased data to help them understand the threats and challenges ahead of their business. The Service industry report further includes market shortcomings, stability, growth drivers, restraining factors, and opportunities over the forecast period.

Get Sample PDF Report with Table and Graphs:

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The Major Manufacturers Covered in this Report @:

Eurofins Scientific, Abbott Laboratories, Invitae Corporation, Fulgent Genetics., Agilent Technologies, Inc., PerkinElmer, Inc., Thermo Fisher Scientific Inc., Genomic Diagnostics, Unilabs, LifeCell International Pvt. Ltd., Trivitron Healthcare and Baebies, Inc.

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The report delivers the financial details for overall and individual Pediatric Genetic Testing market segments for the year 2022-2029 with projections and expected growth rate in percent. The report examines the value chain activities across different segments of Pediatric Genetic Testing industry. The report analyses the current state of performance of the Pediatric Genetic Testing industry and what will be performed by the global Pediatric Genetic Testing industry by 2029. The report analyzes how the covid-19 pandemic is further impeding the progress of the global Pediatric Genetic Testing industry and highlights some short-term and long-term responses by the global market players that are boosting the market gain momentum. The Pediatric Genetic Testing report presents new growth rate estimates and growth forecasts for the period.

Key Questions Answered in Global Pediatric Genetic Testing Market Report:

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This report provides an in-depth and broad understanding of Pediatric Genetic Testing. With accurate data covering all the key features of the current market, the report offers extensive data from key players. An audit of the state of the market is mentioned as accurate historical data for each segment is available during the forecast period. Driving forces, restraints, and opportunities are provided to help provide an improved picture of this market investment during the forecast period 2022-2029.

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Pediatric Genetic Testing Market Scope and overview, To Develop with Increased Global Emphasis on Industrialization 2029 | Eurofins Scientific, Abbott...

Your Health Matters| Meritus Health

Healthy Meritus Gardens provides a place to relax

Meritus Health volunteers see garden project as a way to relieve stresses.

Mike Lewis, The Herald-Mail

Mom jeans might be having a moment, but when it comes to your moms genes, they play an important part in your life and your health.

There are about 20,500 human genes. In recent years, weve learned so much about how genes work and why some diseases run in families, according to Kristy Hose, a nurse practitioner with advanced certifications in genetics, who works for the Meritus Center for Breast Health.

While we cant change our genes, knowing we have a higher-than-average chance of developing certain diseases can help us take steps to lower our risks.

Heres a quick reminder: We each inherit two copies of our genes, one from each parent. They are our personal instruction manual. Proteins do the work of building and maintaining our body. When genes that instruct the making of proteins develop mutations, it can cause disease. Although a mutation in a single gene can cause a disease (for example, sickle cell anemia), most diseases are the result of a combination of mutations along with lifestyle choices (such as smoking) and our environment.

Genes and disease certain known mutations raise our risk for specific diseases. Inherited mutations in the BRCA1 and BRCA2 genes, for example, raise a womans risk of developing breast and ovarian cancer.

Having these mutations does not mean that a woman will definitely develop one of these cancers. It just means shes at a higher risk of doing so, said Hose.

How much more?

According to the National Cancer Institute, about 12% of women who dont have these mutations will develop breast cancer at some point in their lives. In contrast, about 75% of women with the BRCA1 mutation and 69% of those with BRCA2 mutations will develop breast cancer by age 80.

If you have a family history of high blood pressure, you are at risk for developing high blood pressure at a young age. If a man has a father or brother with prostate cancer, it more than doubles the risk he will also have prostate cancer. Even though you cannot change your genetic makeup, knowing your family history can help you reduce your risk of developing health problems, said Hose.

Several common illnesses, including heart disease, high blood pressure, asthma, diabetes and some types of cancer run in families. Knowing your familys health history can help you determine if you have an increased risk, since inherited diseases tend to show up in distinct patterns.

According to Hose, if one or more close relatives have a disease, or they developed it at an earlier-than-average age, you may be at increased risk. When it comes to genetic testing, ask your doctor if the procedure makes sense for you. While it can be helpful for those at high risk, youll want to work with a qualified genetic counselor or go to a clinical human genomic program at a hospital where trained professionals can help you make sense of the results. Genetic testing can provide important, life-saving information.

What should you do today?

Learning about your family medical history can help you and your health care team determine whether genetic testing is likely to be of benefit. Share your family health history with your healthcare provider. In addition to making lifestyle changes (such as quitting smoking or losing weight), they may recommend additional ways to lower your risk, including medical treatments, enhance screenings, preventive medicines, or risk reducing surgery, said Hose.

At Meritus Health, we strive to provide women throughout Maryland and surrounding areas with high quality, trusted health care services. Our womens health services department offers comprehensive OB/GYN care in addition to breast health and maternity services. Find out more at MeritusHealth.com.

Here is the original post:
Knowing we have a chance of developing certain diseases can help us - Herald-Mail Media

Everything Genetic a life sciences company specialising in genetic testing has announced Stuart Dutton as its new Chief Financial Officer(CFO).

Stuart, who joined the team from a corporate financebackground with Sedulo, will apply his track record of growing and transforming tech and retail SMEs for the Cheshire-based business, which offers services spanning cancers, heart disease and Covid.

With a background as a qualified Chartered Accountant, Stuarts former role saw him lead a high growth team, navigating businesses through sales, mergers, acquisitions, and equity fundraisers, which ultimately led him to becoming a non-exec director for several firms.

Commenting on his new role, Stuart said: Im delighted to have been promoted to CFO atEverything Genetic, helpingthe business to work towards delivering on its ambitious growth plans.

In my former roles, I worked closely with several businesses across a variety of sectors, but I really wanted to become fully immersed within a business which had strong growth potential.

2021 was a very successful year for Everything Genetic, which saw us hit 35 million turnover. That enabled us to skip funding rounds and re-invest heavily into the businessto realise the vision of democratising testing.

Last months 5m financing deal was a great initial win for the business, to further realise its potential. Im excited to see where we can go next in further building and diversifying our cancer and wellness offering, in addition to attracting new investors.

Everything Genetics founder and CEO, James Price, said: Stuarts background as an accountant, his growth mindset and familiarity with fundraising processesmade him a perfect fit for us at Everything Genetic.

Were now in a position where we can emerge from the pandemic to re-invest into the cancer and wellness sectors addressing how the country can better utilise genetic testing to overcome some of the UKs most pressing healthcare problems.

Whether building further on the companies weve invested in, our newly expanded facilities, or our recent supplier deal with Tesco, suffice to say, weve had an exciting year so far and I cant wait to see where Stuart can help us go to next.

Everything Genetic is a leading distributor of market-leading genetic testing brands in the UK. The business has a vision to democratise genetic testing to healthcare providers and individuals, for the detection, diagnosis and treatment of cancer, cardiac and other illnesses.

Read more:
EVERYTHING GENETIC APPOINTS NEW CFO TO REALISE AMBITIOUS GROWTH TARGETS - Business Cheshire

HANGZHOU, China and HONG KONG, May 23, 2022 /PRNewswire/ -- New Horizon Health (6606.HK) and Prenetics Group Limited (Nasdaq: PRE, "Prenetics") has announced a strategic partnership to launch ColoClear by Circle (ColoClear), the "First Colorectal Cancer Screening Test approved in China", in Hong Kong, and for its first overseas venture in Southeast Asia. Mr. YeQing Zhu, CEO of New Horizon Health, and Mr. Danny Yeung, CEO and Co-Founder of Prenetics, have conducted joint press conference with nearly 60 mainstream media from Mainland China and Hong Kong.

New Horizon Health and Prenetics will jointly promote ColoClear in Hong Kong, Macau and Taiwan, with additional options to expand the partnership into Southeast Asian markets. Under the terms of the agreement, Prenetics will have the exclusive rights to provide ColoClear laboratory testing service and the profits from the sales of ColoClear will be shared between New Horizon Health and Prenetics. On June 8, ColoClear will be officially launched in Hong Kong.

Preneticsis a global leader in genetics and diagnostic testing, and has successfullylisted on Nasdaq in the US on May 18 via a merger with Artisan Acquisition Corp., becoming Hong Kong's first unicorn to list on the Nasdaq with the ticker "PRE". The company's pillar product pipeline covers prevention, diagnostics and personalized healthcare services, with ColoClear being the key product in disease prevention.

"New Horizon Health and Prenetics share the same vision in healthcare. Prevention and early detection, home-based healthcare, and individualized service have become the major trends in the war on canceraround the globe. We have confidence that with our joint efforts, ColoClear will become a benchmark for Asian innovation, raising awareness in cancer screening while saving many lives," said Mr. YeQing Zhu, CEO of New Horizon Health, "Cancer screening test has to pass a very high bar in order to be approved by regulatory authorities such as FDA and National Medical Products Administration (NMPA). As the only NMPA-approved cancer screening test to-date, ColoClear has enjoyed triple digit growth in 2021, the first year of its commercial launch in China. We are confident in its ability to identify colorectal cancer and precancerous lesion at early stage when it is still curable, and we look forward to working with Prenetics to benefit the broader Asian community."

Mr. Danny Yeung, CEO and Co-Founder of Prenetics also stated, "Cancer screening is an important partof Prenetics's product pipeline and believe ColoClear is a game-changer for the market. Our goal is to decentralize healthcare and bring health closer to millions of patients around the world. ColoClear has a first-mover advantage in Asia's cancer screening market, and judging from the success of Exact Sciences success with Cologuard in the USA, we look forward to deliver rapid growth of ColoClear in the future with New Horizon Health."

Colorectal cancer screening has a huge potential of growth in the Asian market. According to the Frost & Sullivan Research Report, thecolorectal cancer high-risk population in Hong Kong and Southeast Asian countries has reached USD 128 million in 2019. 94.3% of them have never conducted a screening test [1]. The Hong Kong's market in colorectal cancer screening is predicted to grow from USD 1.3 million in 2020 to USD 290 million in 2030, with a ten-year CAGR of 71.7%. On the other hand, the same market in Southeast Asia is predicted to grow from USD 33.4 million in 2020 to USD 2.79 billion in 2030, with ten-year CAGR of 55.7%. [2]

Taking the Hong Kong's marketas an example, according to the Hong Kong Cancer Registry of the Hospital Authority, colorectal cancer has been ranked asthe top two high-incidence cancers in Hong Kong since 2012, while being the second most common cause of cancer death. About one in every 6 to 7 new cancer patients suffers from colorectal cancer. In September 2016, the Department of Health of the Hong Kong SAR Government has launched the Colorectal Cancer Screening Program, subsidizing in phases eligible Hong Kong residents aged 50 to 75 to undergo screening tests for the prevention of colorectal cancer. The program is expected to benefit 300,000 individuals. Currently, FIT and colonoscopy are the most common methods for colorectal cancer detection in the Hong Kong. The average cost of a colonoscopy ranges from HKD 7,800 to HKD 10,420.

As the only cancer screening molecular test approved by the NMPA[3], ColoClear was independently developed by New Horizon Health with USD 100 million investment and over the course of 7 years, including 16 months spent in conducting China's first prospective large-scale multicenter registration trial in cancer screening. The clinical trial data shows that ColoClear has a 95.5% sensitivity for colorectal cancer and 63.5% for advanced adenoma, which is more than twice as high as the traditional FIT, proving it to be highly effective in detecting precancerous lesions. Its NPV (Negative PredictiveValue) for colorectal cancer is 99.6%, minimizing the possibility of false negative[4]. ColoClear's patented FIT-DNA technology is also the only one included in all national guidelines for colorectal cancer screening and treatment published in China so far [5-7]. As of December 31, 2021, ColoClear has been admitted and sold in over 400 hospitals within a year of receiving approval from the NMPA, and has established in-depth strategic cooperation with cross-border leading platforms includinge-commerce companies, insurance companies and private medical check-up centers. New Horizon Health holds the global rights ofColoClear.

In March 2021, New Horizon Health launched its Operation Centre in the Greater Bay Area in Nansha, Guangzhou. With a total area of 1,300 square meters, the Operation Centre is equipped with automatized sample processing and an advanced information system, with an annual capacity of 500,000 cancer screening tests.

[1] Prenetics Investor Presentation (2022.01.19)[EB/OL].

[2]Frost & Sullivan Research Report[EB/OL]. The colonoscope market is not included in this market scale data.

[3]Center for Medical Device Evaluation of NMPA. Current status and clinical technical requirements of colorectal cancer screeningproducts marketed in China and oversea [EB/OL].

[4] Center for Medical Device Evaluation of NMPA. Combination Detection Kit for KRAS Gene Mutation and BMP3/NDRG4 Gene Methylation and FOBT (PCR fluorescent probe method colloidal gold method)Innovation Device Review Report(CSZ2000050) [EB/OL].

[5] "Colorectal cancer screening in China and guidelines for early diagnosis and treatment (2020, Beijing)", Chinese Journal of Oncology, January 2021, Vol. 43 (1) [DB/OL].

[6] Chinese Society of Clinical Oncology, "The 2021 CSCO Clinical Practice Guidelines for Colorectal Cancer", People's Medical Publishing House Co., LTD, April 2021 [M/CD].

[7] Chinese Anti-Cancer Association, "Guidelines for holistic integrative management of cancer in China (CACA)", May 2022 [EB/OL].

About New Horizon Health

Founded in 2015, New Horizon Health is the pioneer and market leader in China's cancer screening market focusing on early detection of high-incidence cancers. On February 18, 2021, New Horizon Health was successfully listed on the Stock Exchange of Hong Kong under the stock code of 6606.HK, becoming the "first cancer screening stock in China".

New Horizon Health's two colorectal cancer screening products, ColoClear and Pupu Tube, as well as aH.pylori screening productUU Tube,have been approved by the National Medical Products Administration (NMPA). ColoClear is currently the only cancer screening product approved by the NMPA. UU Tube is currently the only self-conducted H.pylori screening product for home-use screening test approved in China. In addition, the company has three additional pipeline products for liver, cervical and nasopharyngeal cancer screening. The company holds global rights in all its marketed and pipeline products.

About Prenetics

Founded in 2014, Prenetics (Nasdaq: PRE) is a major global diagnostics and genetic testing company with the mission to bring health closer to millions of people globally and decentralize healthcare by making the three pillars Prevention, Diagnostics and Personalized Care comprehensive and accessible to anyone, at anytime and anywhere. Prenetics is led by visionary entrepreneur, Danny Yeung, with operations across 9 locations, including United Kingdom, Hong Kong, India, South Africa, and Southeast Asia. Prenetics develops consumer genetic testing and early colorectal cancer screening; provides COVID-19 testing, rapid point of care and at-home diagnostic testing and medical genetic testing.

Visit link:
New Horizon Health Partners with Prenetics in Hong Kong to Launch ColoClear, a Non-Invasive Stool DNA Test to Detect Colon Cancer - PR Newswire APAC -...

IPO Edge and the Palm Beach Hedge Fund Association hosted a fireside chat with the CEO & Co-Founder of Prenetics Limited and the CEO & Director of Artisan Acquisition Corporation. Following the recent completion of the merger, newly-listed Prenetics now trades under the ticker PRE on Nasdaq. Topics included the SPAC merger with Artisan, managements background, an overview of Artisan, Prenetics global footprint, recent results, and plans for the future following the business combination. The live event featured Prenetics CEO & Co-Founder Danny Yeung and Artisan CEO & Director Ben Cheng joined by IPO Edge Editor-in-Chief John Jannarone and Editor-at-Large Jarrett Banks in a moderated video session lasting approximately 60 minutes and including a Q&A with the audience.

Watch the two highlight videos below (or click the link underneath to see the entire event):

CLICK HERE TO WATCH THE FULL 1-HOUR REPLAY

About Prenetics:

Founded in 2014, Prenetics is a major global diagnostics and genetic testing company with the mission to bring health closer to millions of people globally and decentralize healthcare by making the three pillars Prevention, Diagnostics and Personalized Care comprehensive and accessible to anyone, at anytime and anywhere. Prenetics is led by visionary entrepreneur, Danny Yeung, with operations across 9 locations, including United Kingdom, Hong Kong, India, South Africa, and Southeast Asia. Prenetics develops consumer genetic testing and early colorectal cancer screening; provides COVID-19 testing, rapid point of care and at-home diagnostic testing and medical genetic testing. To learn more about Prenetics, visit http://www.prenetics.com.

Messrs. Yeung and Cheng discussed:

Background of Danny, Artisan and Prenetics Management Team

Global footprint, success in 2 markets and how this can be replicated in other geographies

Strong financial profile and recent results

Plan to use the proceeds and cash on balance sheet to generate sustainable revenue

Founders vision to ultimately build a health ecosystem

Story continues

About the Speakers:

Danny Yeung is the Co-Founder of Prenetics and has served as Chief Executive Officer since its inception in 2014. Mr. Yeungs journey into healthcare started as a way to utilize his extensive entrepreneurial career into making an impact for society. Mr. Yeungs vision from day 1 was to always turn Prenetics into a global health company, recruiting the best talent, and to give everyone the power to be in control of their own health.

Prior to Prenetics, Mr. Yeung was a Founding Partner at SXE Ventures, having led multiple investments in genetic testing companies and in Honey Science, which was acquired by Paypal for US $4 billion in 2019. Mr. Yeung had also founded uBuyiBuy in 2010, which was subsequently acquired by Groupon. Prior to leaving Groupon in early 2014, Mr. Yeung served as CEO of Groupon East Asia, leading it to be the largest e-commerce company in the region. Mr. Yeungs entrepreneurial journey started at the age of 25 when he ventured into franchising Hong Kong dessert chain Hui Lau Shan into the USA. After exiting Hui Lau Shan, Mr. Yeung successfully ventured into hospitality furniture and executed multi-million-dollar projects with MGM globally. Mr. Yeungs life motto is Play Hard, Work Harder.

Ben Cheng is the Chief Executive Officer and Director of Artisan. He is also currently the Managing Partner at C Ventures, where he leads its sought-after deals and actively engages in major venture capital and private equity investments across the sectors of healthcare, consumer and technology. Named as Chinas Top 20 Most Outstanding Investor by Lieyun.com in 2020, Mr. Cheng has helped execute many investments in the aforementioned unicorns, such as Xpeng Motors, NIO, JD Logistics, Gojek, FTA, Xiaohongshu and Pony.ai.. Mr. Cheng is also a member of the Advisory Committee of Vertex SEA Fund, a subsidiary of Temasek Holdings, and a member of Venture Committee of Hong Kong Venture Capital and Private Equity Association.

Mr. Cheng has also served as a General Manager at New World Development since March 2016 and the Chief Investment Officer of Private Equity Department at ARTA TechFin Corporation Ltd since July 2021. Prior to his current roles, Mr. Cheng was an investment banker at Bank of America Merrill Lynch and Standard Chartered Bank. Mr. Cheng holds a bachelors degree in Quantitative Finance with honors from the Chinese University of Hong Kong

Contact:

Alan Hatfield, Director of Research

ah@capmarketsmedia.com

Twitter: @IPOEdge

Instagram: @IPOEdge

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Video Highlights Covid Testing The English Premier League and Beyond: Join CEOs of Prenetics, Artisan in Fireside Chat - Yahoo Eurosport UK

By Peiyi Ko, Ph.D., and Margaret Dah-Tsyr Chang, Ph.D.

Digital pathology sits at the intersection of pathological diagnosis and precision medicine. In recent years, 3D pathology imaging has developed to achieve precision diagnosis, which can address some challenges in diagnosis excellence.1 Diagnosis is the foundation of effective and quality care; it has profound influence on patient outcomes.2

Using AI/ML to reduce the cognitive demands on clinicians and/or the associated diagnostic errors could help reduce adverse consequences of incorrect or delayed diagnosis in several medical specialties, such as radiology and oncology.3,4 Before leveraging AI/MLs capabilities to support analysis and interpretation of digital images, and further aiding precision medicine by enabling more individualized pathological diagnosis, identification of suitable biomarker ensembles and key parameters for proper classification of patients for a particular disease (i.e., effective companion diagnostics) is needed.5 This understanding and validation will enable application of diagnosis excellence principles, such as better linking diagnosis to treatment, providing more thoughtful interpretation of tests anticipating the probability of specific diagnostic errors, and more consistently quantifying test data to communicate benefits and limitations of diagnostic results.6

In addition, the current probability of success for oncology drug development is low despite its high costs. One of the main difficulties is achieving precision in patient screening, which relies on a pathology diagnosis. There are growing demands for precision cancer diagnosis but an insufficient number of pathologists to make the diagnoses. Therefore, the digital pathology market has grown over the past 10 years. The immuno-oncology drug market size is also increasing, yet tumor microenvironment evaluation is difficult with conventional 2D pathology.Despite playing a key role in clinical decisions for patient treatments for over 150 years, conventional 2D pathology deals with thin slides containing only a small portion of a patients biopsy (about 100 cells in a thin slide of a needle biopsy). Formalin-fixed paraformaldehyde embedded (FFPE) tissue blocks contain abundant medical information (at m resolution) about individual patients, yet the current pathology workflow using visible light reagents is not applicable for labeling spatial features of morphology or biomarker distribution in-depth. Therefore, valuable 3D pathology information of patients in FFPE remains yet to be fully utilized.

The advantages of 3D imaging over 2D can be illustrated by the comparison of computed tomography (CT) to X-ray in radiology imaging. It took quite some time to progress from digitized X-ray film to digital image to CT. One application of X-raycoupled with CT diagnosis is giving more precise parameters for evaluation of COVID-19 infected patient status.7 Digital pathology trends resemble the age of transforming X-ray film to digital images, yet development of 3D digital pathology to support precision diagnosis and precision medicine is quickly evolving. In fact, medical images of large data size have been digitized and are widely used for training AI models, among which radiology images (at mm resolution) derived from X-rays and CT images are thoroughly investigated to develop FDA-approved products.8 One example successfully implemented in hospitals to identify intracranial hemorrhage in support of better and faster clinical decisions is DeepCT, with an AI-powered triage system on head CT images developed by Deep 01 (approved by the FDA in the U.S., Taiwan, and Japan).

In the case of lung cancer and immuno-oncology therapy, a treatment modality (immune checkpoint inhibitor [ICI] therapy of nivolumab in this example) produces varied response in patients, which could be partially explained by the tumor expression of programmed-death-ligand 1 (PD-L1).9 Therefore, PD-L1 expression evaluation by a pathologist has become the standard procedure in patient selection for treatments and PD-L1 has been approved as a companion diagnostic biomarker for several drugs.

However, heterogeneity in PD-L1 expression (in lung cancer and over time) and limited biopsy samples could yield biased information for clinical evaluation and could lead to ineffective treatment. Some patients with high PD-L1 expression did not show positive response to treatment, while some with low PD-L1 expression did. Current discovery of 3D imaging technology (NSCLC 3D PD-L1 profiling) increases the sampling rate with continuous scanning of thick tissue, resulting in 100 times more pathology data from each patient, and tracing heterogeneous PD-L1 expression to give new parameters to support evaluation by the pathologists. After 3D image information is retrieved, the tissue may be reused for 2D hematoxylin and eosin (H&E) and immunohistochemistry (IHC) examination, as well as genetic testing by polymerase chain reaction (PCR). In other words, it allows the same clinical sample to be subsequently examined by multiple diagnosis methodologies and provides more integrated parameters to physicians with minimal changes in the clinical workflow.

Precision diagnosis could not only help cancer patients be matched with the most suitable treatment but also increase the success rate of new therapeutics. Continuing with the lung cancer example, IVD grade PD-L1 IHC assay is the only biomarker approved for patient screening in companion with selective indications of several ICI drugs such as pembrolizumab (Merck), nivolumab (BMS), and atezolizumab (Roche). General cutoff values of tumor proportion scores (TPS) are set as 50%, 10%, and 1% for treatment guidance.

Since PD-L1 expression in tumor tissue is heterogeneous, a pathologists choice of a single slide anywhere in the tissue for conventional IHC assay would often give a different measurement, consequently influencing the treatment plan. Some doctors think that tumor infiltrating T cells or other biomarkers in the tumor microenvironment should be taken into consideration for comprehensive diagnosis. However, it is even more challenging for pathologists to capture enough T cells or other biomarkers co-located in the same plane in the thin single slide (~4 m in thickness), not to mention a complicated calculation.

PD-L1 positive rate for diagnosis is around 20-30%; those patients diagnosed with high PD-L1 will go for ICI treatment with insurance coverage (in Taiwan where the study took place).9 But those primarily diagnosed with a low PD-L1 would need a second chance for thorough inspection of the tissue for the PD-L1 signature to see if they are truly PD-L1 negative. Using computer-assisted PD-L1 quantitation method (i.e., an AI model for tumor cell recognition and PD-L1 positive cell identification) co-developed with pathologists to support diagnosis, a 3D PD-L1 TPS score was generated to categorize results with maximum, minimum, and average of values and compared to the 2D TPS scores and classification. Reclassifications lead to two cases passing the threshold for receiving treatment with medication concordance. This study supports the potential value of using an extra dimension in improving precision in PD-L1 measurement and applying 3D pathology evaluation to the FFPE specimen, which helps address the problem of uncertainties in diagnosis due to insufficient sampling (hence, inconsistencies) and allows patients to have the choice to receive treatment should the improved test results indicate it is appropriate. With further combination with other pathological data and leveraging AI/ML technologies, the 3D pathology based panoramic platform might aid in personalized or more tailored medicine in the future.

In addition to having approved many AI/ML-based medical technologies via 510(k) clearance, premarket approval, and de novo pathways,4 the U.S. FDA, Health Canada, and the U.K.s MHRA have joined efforts to identify 10 guiding principles that will inform the development of good machine learning practice (GMLP) to promote safe, effective, and high-quality devices that use AI/ML.10 This is to address the unique nature of these products (i.e., complex, iterative, and data-driven) and the challenges/special considerations associated with them. Accuracy and consistency of diagnosis, prevention of bias to improve healthcare outcome and reduce costs, as well as articulating the safety and effectiveness of the products are key considerations for companies developing these types of solutions.11

In Part 2 of this article series, we will discuss considerations for collaboration between an AI/ML tech company and a hospital to develop and validate a technology solution for improving healthcare outcomes. Some potential barriers to and options for implementation and adoption of this type of solution in healthcare settings will also be discussed.

References:

About The Authors:

Peiyi Ko, Ph.D., CHFP, is founder and consultant at KoCreation Design LLC. Since 2017, she has researched and promoted integrated quality and adoption of technology by the life science industry. She has executed and managed projects, presented at conferences and university classes, and led workshops. She obtained her Ph.D. from the University of California, Berkeley, where she also completed the Engineering, Business, and Sustainability Certificate and the Management of Technology Certificate programs in 2011. You can reach her atinfo@kocreationdesign.com and connect on LinkedIn.

Margaret Dah-Tsyr Chang, Ph.D., is founder and Chief Strategy Officer of JelloX Biotech Inc. She has expertise in molecular biology and protein engineering supporting biotech-academic collaboration and biomedical translation from university to industry. She has executed and managed research and education projects, offered courses, promoted IP engineering and technology licensing, and organized conferences at National Tsing Hua University, Taiwan. She received her Ph.D. from the Department of Chemistry, Johns Hopkins University, and immediately established the first undergraduate molecular biology laboratory in Taiwan in 1993. You can reach her at margaretdtchang@jellox.com.

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Intelligent Analysis of 3D Pathology Imaging Adds New Dimension To Precision Diagnosis - Med Device Online

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Global Genetic Testing Markets Forecasts, Applications and Technologies Research Report 2022 - ResearchAndMarkets.com - Galveston County Daily News

The UAB Cardiogenomics Clinic provides genetic testing and counseling for a gene variant associated with a risk of heart failure and death.

Researchers believe that the presence of the Val122Ile genetic variant in African Americans is believed to predispose them to the development of transthyretin amyloidosis, which can lead to higher risk of heart failure.A new study published in the Journal of the American Medical Association led by researchers from the University of Alabama at Birmingham Marnix E. Heersink School of Medicine found that being a carrier of a genetic variation known as Val122Ile in the transthyretin, or TTR gene, was significantly associated with an increased risk of heart failure and death. Research shows that this Val122Ile variation is more commonly seen among individuals of African ancestry.

Transthyretin protein is produced by the liver and helps circulate vitamin A and thyroxine through the body. This genetic variation causes misfolding of the transthyretin protein leading to hereditary transthyretin amyloidosis, a condition characterized by the buildup of abnormal deposits of a protein in the bodys organs and tissues. As buildup increases over time, the heart may become stiff, leading to cardiomyopathy, a disease of the heart muscle that makes it difficult to pump blood through the heart.

For this study, UAB researchers Vibhu Parcha, M.D., and Pankaj Arora, M.D., looked at this genetic variation in a cohort of 7,500 Black individuals living in the United States.

The TTR Val122Ile genetic variant is unfortunately more common among those of African ancestry with nearly three out of 100 individuals carrying the genetic variation, said Parcha, a clinical research fellow in the UAB Cardiogenomics Clinic and the UAB Division of Cardiovascular Disease.

Parcha says the presence of the Val122Ile genetic variant in African Americans is believed to predispose them to the development of transthyretin amyloidosis.

We wanted to examine whether carrying this genetic variant will lead to a higher risk of new-onset heart failure, death due to heart failure, cardiovascular causes or any other causes, Parcha said.

(Left) Vibhu Parcha, M.D., clinical research fellow in the UAB Cardiogenomics Clinic and the UAB Division of Cardiovascular Disease. (Right) Pankaj Arora, M.D., an associate professor in the Division of Cardiovascular Disease and director of the UAB Cardiogenomics Clinic.In this study, researchers analyzed participants from the REasons for Geographic and Racial Differences in Stroke study living in the United States without baseline heart failure. Among 7,514 Black participants, the population frequency of the TTR Val122Ile variant was 3.1 percent. Over a median follow-up of 10.9 years, Val122Ile variant carriers had a higher risk of incident heart failure compared with non-carriers. Over a median follow-up of 11.6 years, Val122Ile variant carriers had a higher risk of mortality compared with non-carriers. Overall researchers found that those with the TTR Val122Ile variant had a 2.5-fold higher risk of heart failure and a 40 percent higher risk of death from any reason.

Among those with the pathogenic TTR Val122Ile genetic variation, the heart may gradually become unable to function correctly, which will lead to heart failure and ultimately death, said Arora, an associate professor in the Division of Cardiovascular Disease and director of the UAB Cardiogenomics Clinic. However, the true probability of genetic variation being expressed in all those with the variant is not known, and further work is needed to understand this. The good news is that there are several new treatments approved or awaiting approval for this hereditary heart disease.

Medical facilities like the UAB Cardiogenomics Clinic provide genetic testing for this variant. At the clinic, those who carry this variant will have access to comprehensive genetic counseling and assessment of their heart structure and function.

Those with the variant may be eligible for getting access to evidence-based therapies that improve their heart health and improve their long-term outcomes, Arora said. It is also important to identify any family members who may have the genetic variation as they will benefit from early diagnosis and access to medical therapies that improve their health.

Learn more about the UAB Cardiogenomics Clinic here.

Original post:
Genetic variation common among Black individuals is associated with higher risk of heart failure and death - University of Alabama at Birmingham

This Direct-to-Consumer (DTC) Genetic Testing Market report provides a comprehensive overview of important aspects that will drive market growth such as Market drivers, restraints, prospects, opportunities, restraints, current trends, and technical and industrial advancements. The detailed industry study, industry sector development and improvement, and new product launches presented in this Direct-to-Consumer (DTC) Genetic Testing market report are of tremendous help to the significant new commercial entrants entering the market. This Direct-to-Consumer (DTC) Genetic Testing market report carries out an attentive market assessment and offers an expert analysis of the market considering the market development the current market situation and future projections. This Direct-to-Consumer (DTC) Genetic Testing market report study further highlights the market driving factors, market overview, industry volume, and market share. Since this Direct-to-Consumer (DTC) Genetic Testing market report offers an effective market strategy, key players can reap huge profits by making the right investments in the market. As this Direct-to-Consumer (DTC) Genetic Testing Market report depicts the ever-changing needs of consumers, sellers, and buyers across different regions, it becomes easy to target specific products and attain significant revenue in the global market.

The report includes company profiles of almost all the major players operating in the Direct-to-Consumer (DTC) Genetic Testing market. The Company Profiles section provides valuable analysis of key market players strengths and weaknesses, business developments, recent advances, mergers and acquisitions, expansion plans, global footprint, market presence, and product portfolios. This information can be used by players and other market participants to maximize their profitability and streamline their business strategies. Our competitive analysis also includes key insights to help new entrants identify barriers to entry and assess the level of competitiveness in the Direct-to-Consumer (DTC) Genetic Testing market.

Get Full PDF Sample Copy of Report: (Including Full TOC, List of Tables & Figures, Chart) @https://www.databridgemarketresearch.com/request-a-sample/?dbmr=global-direct-to-consumer-dtc-genetic-testing-market&Somesh=

The direct-to-consumer (DTC) genetic testing market is expected to witness market growth at a rate of 12.15% in the forecast period of 2021 to 2028. Data Bridge Market Research report on direct-to-consumer (DTC) genetic testing market provides analysis and insights regarding the various factors expected to be prevalent throughout the forecast period while providing their impacts on the markets growth. The rise in the incidences ofgenetic disordersglobally is escalating the growth of direct-to-consumer (DTC) genetic testing market.

The report provides an excellent overview of the main macroeconomic factors having a significant impact on the growth of the Direct-to-Consumer (DTC) Genetic Testing market. It also provides the absolute dollar opportunity analysis which can be crucial in identifying revenue generation and sales increasing opportunities in the Direct-to-Consumer (DTC) Genetic Testing market. Market players can use the qualitative and quantitative analysis provided in the report to get a good understanding of the Direct-to-Consumer (DTC) Genetic Testing market and make strong strides in the industry in terms of growth. The overall Direct-to-Consumer (DTC) Genetic Testing market size and that of each segment studied in the report are accurately calculated based on various factors.

Key Players Mentioned in the Direct-to-Consumer (DTC) Genetic Testing Market Research Report:

The major players covered in the direct-to-consumer (DTC) genetic testing market report are EasyDNA, Ancestry, 23andMe, Inc., Colour Genomics, Inc., Genesis HealthCare, Full Genomes Corporation, Inc., Helix OpCo LLC, IDENTIGENE, LLC, Living DNA Ltd, Mapmygenome, Pathway Genomics, Gene by Gene, Ltd., MyHeritage Ltd., 10X Genomics, Dante Labs, Inc., 24Genetics, LabCorp, Myriad Genetics, Inc., Quest Diagnostics Incorporated and Abacus Diagnostica Oy among other domestic and global players. Market share data is available for global, North America, Europe, Asia-Pacific (APAC), Middle East and Africa (MEA) and South America separately. DBMR analysts understand competitive strengths and provide competitive analysis for each competitor separately.

Read Detailed Index of full Research Study @https://www.databridgemarketresearch.com/reports/global-direct-to-consumer-dtc-genetic-testing-market?Somesh=

Direct-to-Consumer (DTC) Genetic Testing Market Segmentations:

Geographic Segment Covered in the Report:

The Direct-to-Consumer (DTC) Genetic Testing report provides information about the market area, which is further subdivided into sub-regions and countries/regions. In addition to the market share in each country and sub-region, this chapter of this report also contains information on profit opportunities. This chapter of the report mentions the market share and growth rate of each region, country, and sub-region during the estimated period.

The market research analysis further talks about the forces of the industry to shape the market. Important drivers and end-user expectations are also discussed in the Direct-to-Consumer (DTC) Genetic Testing market report to gain solutions. The forecast of related revenue is also made in the report. The primary purpose of the report is to categorize opportunities. It also explains what business models are being used, what the current level of success is, what is the market share and size, and what is the current level of competition in the market. It also sheds light on the functional areas of the company. This Direct-to-Consumer (DTC) Genetic Testing market report also shows how dead stock affects profits and how product losses can be eliminated. With the business tactics provided here, it is possible to experience accelerated growth of your business. It also provides a clear picture of how different business sectors are experiencing the negative impact of COVID-19.

New Business Strategies, Challenges & Policies are mentioned in Table of Content, Request TOC @https://www.databridgemarketresearch.com/toc/?dbmr=global-direct-to-consumer-dtc-genetic-testing-market&Somesh=

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Direct-to-Consumer (DTC) Genetic Testing Market Trends Analysis, Top Manufacturers, Shares, Growth Opportunities, Statistics and Forecast by 2028 ...