Archive for the ‘Genetic Testing’ Category

[190+ Pages PDF Report] Facts & Factors (FnF) published a market research report onResearch Report on Direct to Consumer Genetic Testing Market: By Product Type, Size, Share, Applications, Growth, Analysis and Forecast, 2020-2026that includes a research report with TOC including a list of tables and figures in its research offerings.

Direct to Consumer Genetic Testing Market Report: Industry Insights, 2020-2026

This multi-client research study on theDirect to Consumer Genetic Testing marketprovides in-depth research and analysis into Direct to Consumer Genetic Testing industry trends, market developments and technological insights. The report provides data and analysis of Direct to Consumer Genetic Testing penetration across application segments across countries and regions. The report presents a strategic analysis of the Direct to Consumer Genetic Testingy market through key drivers, challenges, opportunities, and growth contributors.

The global Direct to Consumer Genetic Testing market delivers value to customers through reliable market size for 2020 on the basis of demand and price analysis. The report presents near term and long term forecast of the addressable Direct to Consumer Genetic Testing market size to 2026.

The report presents an introduction to the Direct to Consumer Genetic Testing market in 2020, analyzing the COVID-19 impact both quantitatively and qualitatively.

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2020 Direct to Consumer Genetic Testing Market: COVID-19 Impact Analysis

The global rise of COVID-19 has many businesses struggling and confused about what steps to take to minimize the economic impact. A simple look at the stock market will tell you that coronavirus has led to a volatile economy, but there are numerous other factors at play.

The long term COVID-19 impact on the business industry is largely still unknown; hence,Facts and Factors market researchanalysts have already covered the effects of COVID-19 on the business industry at a large level, as well as global and regional levels. Through our coverage below, get a better understanding of the business and economic implications coronavirus has on trends like remote working, consumer shopping behavior, global advertising spend, and essential industries like food, medical, travel, and transportation.

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Direct to Consumer Genetic Testing Market 2020: Research Scope & Coverage

The report coversDirect to Consumer Genetic Testing market sizeand growth, characteristics, segmentation, regional and country breakdowns, competitive landscape, market shares, trends and strategies for this market. It traces the markets historic and forecast market growth by geography. The market size analysis gives the market size covering both the historic growth of the market, the impact of the COVID 19 virus, and forecasting its recovery. The report also provides a comprehensive analysis of current & future trends and emerging avenues for the growth of this market along with this research also offers an insight into the competitive landscape in terms of new technological developments, untapped segments, and value chain analysis.

The report, Direct to Consumer Genetic Testing Market, provides up-to-date information about market size, share shifts, and potential risks, as well as in-depth knowledge of products and services, which can help in planning and in executing category management activities. It focuses on the cost-saving aspects of procurement and on providing insights that can lead to the optimization of category spend.

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Competitive Landscape

The market appears to be fragmented and with the presence of several. Thissize of Direct to Consumer Genetic Testing marketresearch report will help clients identify new growth opportunities and design unique growth strategies by providing a comprehensive analysis of the markets competitive landscape and offering information on the products offered by companies.

Key Takeaways from this Direct to Consumer Genetic Testing Market Report

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Direct to Consumer Genetic Testing Market Size & Share Unfolding the Growth During Forecast Year 2020-2026 - Kewaskum Statesman News Journal

Each month,TheClinical Advisormakes one new clinical feature available ahead of print. Dont forget to take the poll. The results will be published in the next months issue.

Major depressive disorder (MDD) is a common mental disorder that affects more than 264 million people worldwide and is a leading cause of disability, including death by suicide.1 MDD is a complicated disorder that involves the interaction of social, psychological, and biological factors.1 MDD can prevent patients from living healthy, productive lives and can complicate treatment of other comorbid conditions.1

Although MDD commonly is encountered in primary care settings, its treatment has become integrated into all fields of medicine due to its high prevalence. Cognitive behavioral therapy, interpersonal psychotherapy, and antidepressants, such as selective serotonin reuptake inhibitors and tricyclic antidepressants, are the mainstays of MDD treatment.1

Prescribing an antidepressant may be simple, but that does not make it easy. Efficacy and tolerability of antidepressants vary among patients, which can make it challenging to relieve patients symptoms.2 Although no genes have been associated with depression,3 several genetic variants may help clinicians predict how patients with MDD will metabolize antidepressants.4 Performing genetic testing of patients with MDD and matching patients with an antidepressant class based on identification of genetic variants that convey sensitivity to particular antidepressants could improve response to drug therapy in patients with MDD.5

The process of selecting an antidepressant should take into account cost, tolerability, adverse effect profiles, and patient preferences.2 When evaluating treatment options for patients with MDD, the current standard of care is to initiate an antidepressant at a starting dose and reassess effectiveness within 2 to 4 weeks, with adjustments to monitoring frequency dependent on the patients suicide and self-harm risk, comorbid conditions, age, and concomitant medication use.2

Several metrics are used to determine whether a selected antidepressant is working:

Clinicians can mitigate adverse effects by decreasing the dosage or switching to a different class of antidepressant. However, several weeks are needed after each change in drug or dose alteration to truly assess response. Finding and settling on a drug that produces a response with minimal adverse effects can take months. During the trial period, patients may become frustrated with the process and stop therapy and/or may be at increased risk for suicide or self-harm.

The study of drug metabolism in patients with MDD is a growing area of interest.3-5 A management approach incorporating pharmacogenetic testing in combination with clinical judgment may be superior to the standard trial and error method for finding an effective antidepressant regimen and could improve patient outcomes.5

Genome-wide association studies are used to identify single nucleotide polymorphisms (SNPs) in genes related to a particular disease or drug metabolism.6 Several laboratory testing companies offer pharmacogenetic panels to evaluate metabolism of drugs used to treat MDD.3 The FDA also has approved direct-to-consumer genetic testing panels (eg, 23andMe), which are widely available to the public without a health care providers prescription.7 A concern with these latter tests is that the results of these tests are reported directly from the company to the patient; thus, the patient decides whether or not to present the information to his or her health care provider. Many pharmacogenetic testing panels also include genes that have shown correlations with the pathogenesis of MDD, despite the lack of clinical research replicating the role of these genes in the disorder.3

From the October 2020 Issue of Clinical Advisor

Originally posted here:
Pharmacogenetic Testing: Does it Improve Therapy in Patients With MDD? - Clinical Advisor

Eczema (a.k.a. atopic dermatitis) isnt rarein fact, the National Eczema Association reports that over 31 million Americans are currently living with the skin condition. Though it usually begins in childhood, eczema can crop up at any time, causing itchy, dry skin that comes and goes in flares. Its more severe in some people than others, but one thing is certain: Its not exactly a walk in the park to deal with.

But now, scientific breakthroughs are revealing more about the genetic origins of eczema. An August 2020 study in Nature Communications found that two common mutations of the KIF3A gene are responsible for an impaired skin barrier, which can contribute to the development and onset of atopic dermatitis. KIF3A is a gene that we found to be very important in determining skin barrier function in people, says Gurjit Neeru Khurana Hershey, M.D., director of the Division of Asthma Research at Cincinnati Children's Hospital in Cincinnati, OH, and principal investigator on the study. Individuals that carry common genetic variants in this gene had disrupted skin barrier function as evidenced by increased loss of water through their skin. This promotes skin dehydration, which increases the odds that someone will start feeling that dreaded eczema itch.

Heres why this genetic discovery is so huge: Identifying these genes early on could help doctors identify children at risk of developing eczema and a whole host of related health problems like asthma and allergies later in life.

The cause of eczema isnt totally clear, but scientists know it has something to do with both nurture (external factors) and nature (family history). Research in the Expert Review of Clinical Immunology found evidence for several environmental risk factors, including personal care product use, air pollution, climate factors like heat and humidity, and even dietary choices.

If eczema runs in your family, your chance of getting it is significantly higher, with or without those external triggers. One possible reason: You've inherited certain genetic mutations from your parents. Jonathan Silverberg, M.D., associate professor of dermatology at The George Washington University School of Medicine and Health Sciences in Washington, D.C., notes that researchers had previously identified mutations of the Filaggrin (FLG) gene as playing a role in atopic dermatitis. The KIF3A gene (the one in this current study) was also previously associated with atopic dermatitis and allergic disease, but its role was not precisely understood.

This study has several significant findings that bridge genetic associations to potential pathomechanisms of atopic dermatitis, Dr. Silverberg saysmeaning, the ways in which eczema starts occurring in the first place.

So, now youre probably wondering OK, so what can I actually do with this information? Though it doesnt change anything right this instant, this finding could lead to better genetic testing to identify infants at high risk for eczema. And since half of people with moderate to severe eczema go on to develop asthma, hay fever, or food allergies, early detection would help doctors be on the lookout forand proactively treatthese additional health complications. I hope that testing for this genetic variation will help identify kids at risk for food allergy and asthma before they develop, so we can prevent disease onset or attenuate their disease, Dr. Hershey says.

Unfortunately, prevention is a bit complicated. Dr. Silverberg explains that researchers have tried a variety of interventions aimed at preventing or mitigating eczema, including moisturizers, prebiotics, probiotics, and avoidance of external triggers like dust mites. While individual studies showed possible benefits, none of these have conclusive evidence to support their recommendation in routine practice, he says. So, at this point, even if we could identify children at higher risk for atopic dermatitis, there isnt that much we can do about it.

Dr. Hershey hopes this new research will lead to specific treatment approaches that target the KIF3A gene. Ideally, scientists would discover a way to repair skin barrier function in infants before they have noticeable eczema symptomsthereby stopping it before it starts.

If you or a loved one lives with eczema, you know how life-changing this breakthrough could be. The psychosocial and mental health burden of atopic dermatitis can be improved tremendously simply by achieving tighter control of the signs and symptoms of atopic dermatitis, Dr. Silverberg says. This isnt the golden ticket (yet), but its one step closer to getting there.

Read more:
The Eczema Gene Thats Kind of a Big Deal - HealthCentral.com

FT MYERS, FL / ACCESSWIRE / September 10, 2020 / NeoGenomics, Inc. (NASDAQ:NEO), a leading provider of cancer-focused genetic testing services, today announced that Doug VanOort, Chairman and Chief Executive Officer, Kathryn McKenzie, Chief Financial Officer and Doug Brown, Chief Strategy and Corporate Development Officer, will be participating in a virtual fireside chat at the 18th Annual Morgan Stanley Global Healthcare Conference on Monday, September 14, 2020 at 9:45am ET.

The presentation will be webcast live and accessible online via the investors section of the Company's website, http://www.neogenomics.com. A replay of the webcast will be archived for 90 days following the presentation.

About NeoGenomics, Inc.

NeoGenomics, Inc. specializes in cancer genetics testing and information services. The Company provides one of the most comprehensive oncology-focused testing menus in the world for physicians to help them diagnose and treat cancer. The Company's Pharma Services Division serves pharmaceutical clients in clinical trials and drug development.

Headquartered in Fort Myers, FL, NeoGenomics operates CAP accredited and CLIA certified laboratories in Fort Myers and Tampa, Florida; Aliso Viejo, Carlsbad, Fresno and San Diego, California; Houston, Texas; Atlanta, Georgia; Nashville, Tennessee; and CAP accredited laboratories in Rolle, Switzerland, and Singapore. NeoGenomics serves the needs of pathologists, oncologists, academic centers, hospital systems, pharmaceutical firms, integrated service delivery networks, and managed care organizations throughout the United States, and pharmaceutical firms in Europe and Asia. For additional information about NeoGenomics, visit http://www.neogenomics.com/.

Forward Looking Statements

Certain information contained in this press release constitutes forward-looking statements for purposes of the safe harbor provisions of The Private Securities Litigation Reform Act of 1995. These forward looking statements involve a number of risks and uncertainties that could cause actual future results to differ materially from those anticipated in the forward-looking statements as the result of the Company's ability to continue gaining new customers, respond to the effects of the COVID-19 outbreak, offer new types of tests, integrate its acquisitions and otherwise implement its business plan, as well as additional factors discussed under the heading "Risk Factors" and elsewhere in the Company's Annual Report on Form 10-K filed with the SEC on February 28, 2020. As a result, this press release should be read in conjunction with the Company's periodic filings with the SEC. In addition, it is the Company's practice to make information about the Company available by posting copies of its Company Overview Presentation from time to time on the Investor Relations section of its website at http://ir.neogenomics.com/.

Forward-looking statements represent the Company's estimates only as of the date such statements are made (unless another date is indicated) and should not be relied upon as representing the Company's estimates as of any subsequent date. While the Company may elect to update forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, even if its estimates change.

For further information, please contact:

NeoGenomics, Inc.

Doug BrownChief Strategy and Corporate Development OfficerT: 239.768.0600 x2539M: 704.236.2064doug.brown@neogenomics.com

Charlie EidsonManager of Investor Relations and Manager of Strategy and Corporate DevelopmentT: 239.768.0600 x2726M: 952.221.8816charlie.eidson@neogenomics.com

SOURCE: NeoGenomics, Inc.

View source version on accesswire.com: https://www.accesswire.com/605665/NeoGenomics-To-Virtually-Participate-In-Fireside-Chat-At-The-18th-Annual-Morgan-Stanley-Global-Healthcare-Conference

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NeoGenomics To Virtually Participate In Fireside Chat At The 18th Annual Morgan Stanley Global Healthcare Conference - Yahoo Finance

A Boston consumer genetics company that has batted away former employees accusations of shoddy practices since at least 2019 is now under investigation by the state Department of Public Health for logging hundreds of false positive coronavirus test results, including some in Fall River and Taunton.

The company, Orig3n, has halted COVID-19 testing in the state. A company spokesman said the false positives were due to human error in processing the tests.

In August, after learning about the Massachusetts investigation, North Carolina issued a stop order for its coronavirus testing contract with the company, Orig3n.

The consumer genetics start-up, which claims it can tell customers what kind of foods they should eat and whether theyre predisposed to intelligence based on their DNA, has secured some of the biggest coronavirus testing contracts in the country.

According to an Orig3n spokesman, the company continues to offer COVID-19 testing elsewhere in the U.S.

So far, the Massachusetts DPH has found Orig3n sent out more than 300 COVID-19 tests wrongly classified as positive in Massachusetts, a number that could increase as DPH staff continue investigating. Orig3n claims the company isnt aware of any additional false positives. According to a Harvard epidemiologist and lab director, false negatives are far more difficult to discover, because most tests come back as negative.

Ted Owens, CEO at North Hills Pines Edge skilled nursing facility in Needham, one of roughly 60 long-term care facilities that used Orig3n test services, said in an Aug. 11 bulletin to residents and staff that Orig3n returned a total of 19 false positives to the nursing home.

The numbers didnt seem credible to Owens, but Pines Edge began immediately to take actions based on the working assumption that we needed to treat these results as correct.

It turned out that several other skilled nursing facilities also showed an unusual spike in positive cases last week, and oddly enough, all these facilities had used the same testing vendor, Owens continued. This caught the attention of the epidemiologists at Mass DPH, who intervened and instructed the vendor to re-test the samples.

Upon retesting, all of the positive tests were found to be negative.

The spike in cases -- which turned out to be false positives -- caused a panic in Needham. They came as the school district made plans to return to in-person learning, and a public health nurse for the town was asked to appear before its Select Board.

Needham Public Health Nurse Tiffany Zike told the Board on Aug. 18 that a number of coronavirus cases reported in July were considered false cases that were revoked due to the lab having an issue.

A $25,000 wire transfer

In early May, nursing homes across Massachusetts were looking for a miracle.

The Massachusetts DPH had ordered long-term care facilities coping with severe coronavirus outbreaks to test 90% of residents and staff for COVID-19 by May 25 in order to qualify for a portion of the $130 million in relief funding offered by the state.

Many nursing homes struggled to meet the deadline because of a shortage of COVID-19 tests. The National Guard was testing nursing home residents and staff on behalf of the state, but demand was high.

When Ron Doty got a memo from the Massachusetts Senior Care Association on May 6 offering Orig3n as a turnkey mobile testing option, he immediately reached out to the company.

Doty, administrator at Marlborough Hills Rehabilitation & Health Care Center in Marlborough, wired $25,000 to Orig3n. The next day, he received 250 COVID-19 test kits from the company.

Two months later, Orig3n was asked to suspend COVID-19 testing in Massachusetts, which it did on Aug. 8. Staff at the Massachusetts DPH noticed the lab was reporting an unusually high rate of positive tests, prompting the agency to investigate, according to a DPH spokesperson.

The state DPH declined to identify which nursing homes used Orig3ns testing services, citing the ongoing investigation.

Tony Plohoros, Orig3ns spokesman, said the lab is now working with state health officials to correct problems in its Boston lab, which has ceased processing coronavirus samples but continues to process consumer genetic profiles.

While it remains unclear if the federal government has taken action to halt use of Orig3ns COVID-19 testing services in other parts of the country, as North Carolina did, concerns about Orig3n hadnt yet reached a health care supply company in Ohio as of this week. That company, Link-age Solutions, is still working with Orig3n to provide coronavirus tests to long-term care facilities nationwide.

Patrick Schwartz, a spokesman for Link-age Solutions, said Thursday the company was unaware Orig3n was asked to cease coronavirus testing in Massachusetts.

One of the highest accuracy ratings in the market

Orig3n received an emergency authorization to conduct COVID-19 testing from the Food & Drug Administration in April.

The same month, the company received a federal Paycheck Protection Program loan valued between $350,000 and $1 million from Silicon Valley Bank, according to U.S. Treasury data.

Since getting the FDA approval, Orig3n has provided testing services to The New England Power Generators Association, Bostons homeless population, a boarding school in Virginia, and other public and private entities.

In late June, Link-age Solutions, a Mason, Ohio-based company that helps long-term care facilities nationwide obtain supplies ranging from pharmaceuticals to office supplies issued a press release touting Orig3ns breakthrough testing method as having one of the highest accuracy ratings in the market.

In partnering with Orig3n, Link-age could offer in-demand coronavirus tests to its members at a reduced cost, according to the press release. Results would be returned less than 36 hours after specimens arrived at the lab, the release said.

The lab boasts output capabilities of 6,000 and up to 12,000 tests per day, and will offer billing to Medicare where appropriate, the press release stated. Reporters questions to the Centers for Medicare & Medicaid Services have gone unanswered.

Schwartz, the Link-age spokeman, said Thursday his company continues to offer COVID-19 testing services performed by Orig3n, and that feedback about Orig3ns tests from its customers has been positive.

Company flagged in the past

Orig3n lists its office location as the third floor of 27 Drydock Ave. in the heart of Bostons Seaport. Until August, thats where the company processed its coronavirus tests.

Before it got into the coronavirus business, Orig3n billed itself as a consumer genetics pioneer, carving a path toward a future of wellness and health through the use of diagnostics, genetics and biotechnology.

The company, founded in 2014, offers tests ranging in cost from $29 to $298 that are supposed to help people learn what kinds of food, exercise and beauty products would work best for their genetic profiles, and even whether they are genetically predisposed to so-called superhero traits including intelligence and strength, according to Bloomberg Businessweek.

A former Orig3n employee who spoke to Gannett New England reporters on the condition of anonymity because of a nondisclosure agreement with the company said the number one complaint received by customer service was genetic profile tests not being returned to customers. The employee, who left the company pre-pandemic, didnt think the company could handle both genetic profile testing and coronavirus testing.

Unless things drastically changed since I have left, not even testing, just bandwidth-wise, they were already kind of drowning when I left, the employee said.

Despite its start-up status, Orig3n quickly gained prominence partly through securing big-name partnerships, including one with the NFLs Baltimore Ravens.

In September 2017, the Ravens linked up with Orig3n for an event called DNA Day. Roughly 70,000 Ravens fans were set to pour into the teams stadium, where they could have picked up a free genetic testing kit.

The event never happened. The Ravens postponed it days before federal health officials told The Baltimore Sun they were, working to determine whether any of the testing being offered by Orig3n is subject to the requirements of the Clinical Laboratory Improvement Amendments of 1988.

The federal regulatory standards apply to labs testing human samples in the United States, and are intended to ensure accuracy, effectiveness and reliability.

About a year after DNA Day was scrapped, 17 former Orig3n employees criticized the company in Bloomberg Businessweek, alleging it, habitually cut corners, tampered with or fabricated results, and failed to meet basic scientific standards.

Marketing, not science, the employees said, was the companys priority.

Press releases put out by Orig3n throughout the pandemic show the company was eager to publicize contracts with respected institutions, both public and private.

On May 12, the company announced what it called a comprehensive solution to enable COVID-19 testing for Massachusetts nursing home residents.

In the press release, the company said it sought to become the partner of choice for coordinating and providing COVID-19 testing for defined populations beyond long-term care residents and employees, including private employers, schools, government agencies, and cities and states.

The nursing home program is one of many applications for Orig3ns fully-integrated solution, the press release said.

What went wrong?

Doty, the Marlborough nursing home administrator, would not have known about Orig3n if not for the May 6 memo from Massachusetts Senior Care Association, an organization many nursing homes relied on during the viruss spring surge in the state to interpret complex and shifting guidance from the DPH.

Massachusetts Senior Care Association President Tara Gregorio said in a statement that her organization essentially serves as a messenger for its members, and that it relies on governmental agencies to vet labs like Orig3n.

Throughout the pandemic, MSCA has passed along lists of government approved COVID-19 PCR testing labs options available to our members, Gregorio wrote. We must rely, as all providers do, on the licensing process to ensure legitimacy and accuracy of these labs.

The FDA, which gave Orig3n emergency authorization to conduct coronavirus testing last spring, has not yet responded to Gannett New England reporters seeking comment.

According to a Massachusetts DPH spokesman, Orig3n told the agency after it was contacted by DPH that errors in testing occurred because of a broken vial or contaminated plate during final processing, an explanation DPH investigators are now trying to confirm.

In an email to Gannett New England reporters on Friday, Plohoros, Orig3ns spokesman, said, human error at the beginning of the laboratory testing process caused a pre-extraction reagent that was used in the affected batch tests to become contaminated.

In an Aug. 18 press conference, Massachusetts Secretary of Health and Human Services Marylou Sudders said erroneous results from Orig3n affected the number of COVID-19 cases reported in Fall River and Taunton.

The positive test rates for that three-day period for that one lab just seemed high, and so (we) went back, and the lab stopped processing, theyre still not processing any tests, Sudders said, adding that DPH staff was analyzing tests processed prior to the discovery to make sure the issue was, as Orig3n told the DPH, a one-time problem rather than a more structural issue.

Dr. Michael Mina is an assistant professor of epidemiology at Harvard T. H. Chan School of Public Health who has experience running laboratories that perform PCR testing.

Mina says a lab that processes 6,000 to 12,000 PCR coronavirus tests a day as Orig3n has said it does would need to be run with what he called extreme quality control measures.

It requires an amazing amount of concentration and care to really ensure youre not getting contamination or any number of other problems that can happen, he said. If this was an easy (test), I would have said, sure, any lab can do it but this particular (test) ... it really is a finicky test. You have to be extremely careful about how youre doing it, and that means you need a lot of quality controls. You need to be a really diligent lab.

Mina, who stressed he has no knowledge of Orig3n other than circulating allegations that the company had previously been investigated, said when a mistake like the kind Orig3n described occurs, staff should immediately stop processing, sterilize the area and alert any affected patients and health departments.

The fact that the Massachusetts DPH noticed the problem and not Orig3n is a problem, Mina said.

That shows in general that the quality control wasnt being maintained, he said, adding that performing intense quality control checks multiple times daily is a core tenet of running any lab, especially a high-complexity clinical lab. And if were giving them the benefit of the doubt, they didnt know that there was a problem because otherwise its just nefarious.

Mina said that a professionally run lab would likely have caught the mistake, and alerted the state DPH immediately.

Part of the reason for that is simply a motive to care for the patient, who will likely make important decisions about their own behavior based on the test result they receive, which in turn affect other people.

At Brigham, for example, where I was one of the medical directors, of course people feel embarrassed (about making a mistake), but theres this strong culture where people recognize that their embarrassment is not worth a patients hardship, Mina said. Thats one thing that really, I think, lacks a little bit when we move into industry laboratories running clinical tests. That same spirit of honesty ... might not exist everywhere.

While mistakes at labs are common, Mina said, theyre also commonly fixed and they dont usually require an investigation.

Mina said that the U.S. did need to increase its capacity to process coronavirus tests this spring, but labs, especially ones new to the medical diagnostics space, as Orig3n is, need to be monitored closely.

Its just important to keep all these things in check, Mina said. The frenzy to do coronavirus testing has been so extreme. I dont think labs should be immediately shut down for mistakes, but we have to remain vigilant to ensure that all the testing that is being done is up to the highest standards.

Continued here:
Genetics start-up continues COVID-19 testing as DPH probes testing errors, including some in Fall River, Taunton - Fall River Herald News

The research document entitled Global Newborn and Prenatal Genetic Testing Market Growth (Status and Outlook) 2020-2025 by MarketsandResearch.biz studies and gauges through the current market forces that shows growth direction and holistic growth trends. The report acts as a thorough synopsis on the study, analysis, and estimation of the market. The report offers a concise summary of the global Newborn and Prenatal Genetic Testing market trends, end-user, regions, types, market size, revenue estimation, and geographical outlook. People seeking for their business growth on both local and global level as well as producers, newcomers in the industry, professional association, private businesses, and commercial marketers, will get a thorough assessment of the report.

Enumerating Some of The Most Important Pointers Addressed In The Report:

The report descriptively draws out the competitive backdrop of eminent players driving the market, including their product offerings and growth plans. The regional segmentation has been analyzed in terms of business opportunities, demand & supply, and revenue generation potential. The global Newborn and Prenatal Genetic Testing market distinctiveness depicted from the report is assessed to inherent and technological stance to get a better comprehension of the industry. Each geographic portion of the global Newborn and Prenatal Genetic Testing industry showcase has been freely overviewed nearby valuing, dissemination, and request information for the main geographic market.

NOTE: Our analysts monitoring the situation across the globe explains that the market will generate remunerative prospects for producers post COVID-19 crisis. The report aims to provide an additional illustration of the latest scenario, economic slowdown, and COVID-19 impact on the overall industry.

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Some well-known companies identified to operate in the global market are: Perkin Elmer, CapitalBio MedLab, Verinata Health, Agilent Technologies, Inc., Bio-Rad Laboratories, Inc., Sequenom, Inc., Ariosa Diagnostics, Natera, Inc., BGI, Illumina, Inc.,

Regional segment analysis displaying regional production volume, consumption volume, revenue, and growth rate from 2020-2025 covers: Americas (United States, Canada, Mexico, Brazil), APAC (China, Japan, Korea, Southeast Asia, India, Australia), Europe (Germany, France, UK, Italy, Russia), Middle East & Africa (Egypt, South Africa, Israel, Turkey, GCC Countries)

Moreover, the report highlights product launches, promotional activities, and brand tendencies, as well as ventures, acquisitions, and mergers and consolidation. The market research report classifies the competitive spectrum of this global Newborn and Prenatal Genetic Testing industry in a comprehensive manner. The raw material chain and the supply chain are described to make the user aware of the prevailing costs in the market. Our research analysts have exceptional knowledge and experience in terms of the latest market research techniques and approaches.

Segment by product type, this report focuses on consumption, market share, and growth rate of the market in each product type and can be divided into: PCR, FISH, aCGH, NIPT, MSS,

Segment by application, this report focuses on consumption, market share, and growth rate of the market in each application and can be divided into: Hospital, Clinic, Other

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Global Newborn and Prenatal Genetic Testing Market Insights, Industry Top Manufactures, Analysis and Forecast 2020 to 2025 - The Market Correspondent

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Along with a generalized market study, the report also consists of the risks that are often neglected when it comes to the Direct-To-Consumer (DTC) Genetic Testing industry in a comprehensive manner. The study is also divided in an analytical space where the forecast is predicted through a primary and secondary research methodologies along with an in-house model.

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Key players in the global Direct-To-Consumer (DTC) Genetic Testing market covered in Chapter 4:,Myriad Genetics,MD Revolution,DeCODEme,23andMe,Genetrainer,GeneByGene,DNA DTC,Genecodebook Oy,Navigenics

In Chapter 11 and 13.3, on the basis of types, the Direct-To-Consumer (DTC) Genetic Testing market from 2015 to 2026 is primarily split into:,Genome Data Bank Material Model,Individual Health Planning Model,Comprehensive Genome Tests Model,Medical Precision Tests Model,Restricted Trait Tests Model

In Chapter 12 and 13.4, on the basis of applications, the Direct-To-Consumer (DTC) Genetic Testing market from 2015 to 2026 covers:,Hospital,Doctors Office,Other

Geographically, the detailed analysis of consumption, revenue, market share and growth rate, historic and forecast (2015-2026) of the following regions are covered in Chapter 5, 6, 7, 8, 9, 10, 13:,North America (Covered in Chapter 6 and 13),United States,Canada,Mexico,Europe (Covered in Chapter 7 and 13),Germany,UK,France,Italy,Spain,Russia,Others,Asia-Pacific (Covered in Chapter 8 and 13),China,Japan,South Korea,Australia,India,Southeast Asia,Others,Middle East and Africa (Covered in Chapter 9 and 13),Saudi Arabia,UAE,Egypt,Nigeria,South Africa,Others,South America (Covered in Chapter 10 and 13),Brazil,Argentina,Columbia,Chile,Others

For a global outreach, the Direct-To-Consumer (DTC) Genetic Testing study also classifies the market into a global distribution where key market demographics are established based on the majority of the market share. The following markets that are often considered for establishing a global outreach are North America, Europe, Asia, and the Rest of the World. Depending on the study, the following markets are often interchanged, added, or excluded as certain markets only adhere to certain products and needs.

Here is a short glance at what the study actually encompasses:,Study includes strategic developments, latest product launches, regional growth markers and mergers & acquisitions,Revenue, cost price, capacity & utilizations, import/export rates and market share,Forecast predictions are generated from analytical data sources and calculated through a series of in-house processes.

However, based on requirements, this report could be customized for specific regions and countries.

Brief about Direct-To-Consumer (DTC) Genetic Testing Market Report with [emailprotected] https://hongchunresearch.com/report/direct-to-consumer-dtc-genetic-testing-market-size-2020-76522

Some Point of Table of Content:

Chapter One: Report Overview

Chapter Two: Global Market Growth Trends

Chapter Three: Value Chain of Direct-To-Consumer (DTC) Genetic Testing Market

Chapter Four: Players Profiles

Chapter Five: Global Direct-To-Consumer (DTC) Genetic Testing Market Analysis by Regions

Chapter Six: North America Direct-To-Consumer (DTC) Genetic Testing Market Analysis by Countries

Chapter Seven: Europe Direct-To-Consumer (DTC) Genetic Testing Market Analysis by Countries

Chapter Eight: Asia-Pacific Direct-To-Consumer (DTC) Genetic Testing Market Analysis by Countries

Chapter Nine: Middle East and Africa Direct-To-Consumer (DTC) Genetic Testing Market Analysis by Countries

Chapter Ten: South America Direct-To-Consumer (DTC) Genetic Testing Market Analysis by Countries

Chapter Eleven: Global Direct-To-Consumer (DTC) Genetic Testing Market Segment by Types

Chapter Twelve: Global Direct-To-Consumer (DTC) Genetic Testing Market Segment by Applications12.1 Global Direct-To-Consumer (DTC) Genetic Testing Sales, Revenue and Market Share by Applications (2015-2020)12.1.1 Global Direct-To-Consumer (DTC) Genetic Testing Sales and Market Share by Applications (2015-2020)12.1.2 Global Direct-To-Consumer (DTC) Genetic Testing Revenue and Market Share by Applications (2015-2020)12.2 Hospital Sales, Revenue and Growth Rate (2015-2020)12.3 Doctors Office Sales, Revenue and Growth Rate (2015-2020)12.4 Other Sales, Revenue and Growth Rate (2015-2020)

Chapter Thirteen: Direct-To-Consumer (DTC) Genetic Testing Market Forecast by Regions (2020-2026) continued

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List of tablesList of Tables and FiguresTable Global Direct-To-Consumer (DTC) Genetic Testing Market Size Growth Rate by Type (2020-2026)Figure Global Direct-To-Consumer (DTC) Genetic Testing Market Share by Type in 2019 & 2026Figure Genome Data Bank Material Model FeaturesFigure Individual Health Planning Model FeaturesFigure Comprehensive Genome Tests Model FeaturesFigure Medical Precision Tests Model FeaturesFigure Restricted Trait Tests Model FeaturesTable Global Direct-To-Consumer (DTC) Genetic Testing Market Size Growth by Application (2020-2026)Figure Global Direct-To-Consumer (DTC) Genetic Testing Market Share by Application in 2019 & 2026Figure Hospital DescriptionFigure Doctors Office DescriptionFigure Other DescriptionFigure Global COVID-19 Status OverviewTable Influence of COVID-19 Outbreak on Direct-To-Consumer (DTC) Genetic Testing Industry DevelopmentTable SWOT AnalysisFigure Porters Five Forces AnalysisFigure Global Direct-To-Consumer (DTC) Genetic Testing Market Size and Growth Rate 2015-2026Table Industry NewsTable Industry PoliciesFigure Value Chain Status of Direct-To-Consumer (DTC) Genetic TestingFigure Production Process of Direct-To-Consumer (DTC) Genetic TestingFigure Manufacturing Cost Structure of Direct-To-Consumer (DTC) Genetic TestingFigure Major Company Analysis (by Business Distribution Base, by Product Type)Table Downstream Major Customer Analysis (by Region)Table Myriad Genetics ProfileTable Myriad Genetics Production, Value, Price, Gross Margin 2015-2020Table MD Revolution ProfileTable MD Revolution Production, Value, Price, Gross Margin 2015-2020Table DeCODEme ProfileTable DeCODEme Production, Value, Price, Gross Margin 2015-2020Table 23andMe ProfileTable 23andMe Production, Value, Price, Gross Margin 2015-2020Table Genetrainer ProfileTable Genetrainer Production, Value, Price, Gross Margin 2015-2020Table GeneByGene ProfileTable GeneByGene Production, Value, Price, Gross Margin 2015-2020Table DNA DTC ProfileTable DNA DTC Production, Value, Price, Gross Margin 2015-2020Table Genecodebook Oy ProfileTable Genecodebook Oy Production, Value, Price, Gross Margin 2015-2020Table Navigenics ProfileTable Navigenics Production, Value, Price, Gross Margin 2015-2020Figure Global Direct-To-Consumer (DTC) Genetic Testing Sales and Growth Rate (2015-2020)Figure Global Direct-To-Consumer (DTC) Genetic Testing Revenue ($) and Growth (2015-2020)Table Global Direct-To-Consumer (DTC) Genetic Testing Sales by Regions (2015-2020)Table Global Direct-To-Consumer (DTC) Genetic Testing Sales Market Share by Regions (2015-2020)Table Global Direct-To-Consumer (DTC) Genetic Testing Revenue ($) by Regions (2015-2020)Table Global Direct-To-Consumer (DTC) Genetic Testing Revenue Market Share by Regions (2015-2020)Table Global Direct-To-Consumer (DTC) Genetic Testing Revenue Market Share by Regions in 2015Table Global Direct-To-Consumer (DTC) Genetic Testing Revenue Market Share by Regions in 2019Figure North America Direct-To-Consumer (DTC) Genetic Testing Sales and Growth Rate (2015-2020)Figure Europe Direct-To-Consumer (DTC) Genetic Testing Sales and Growth Rate (2015-2020)Figure Asia-Pacific Direct-To-Consumer (DTC) Genetic Testing Sales and Growth Rate (2015-2020)Figure Middle East and Africa Direct-To-Consumer (DTC) Genetic Testing Sales and Growth Rate (2015-2020)Figure South America Direct-To-Consumer (DTC) Genetic Testing Sales and Growth Rate (2015-2020)Figure North America Direct-To-Consumer (DTC) Genetic Testing Revenue ($) and Growth (2015-2020)Table North America Direct-To-Consumer (DTC) Genetic Testing Sales by Countries (2015-2020)Table North America Direct-To-Consumer (DTC) Genetic Testing Sales Market Share by Countries (2015-2020)Figure North America Direct-To-Consumer (DTC) Genetic Testing Sales Market Share by Countries in 2015Figure North America Direct-To-Consumer (DTC) Genetic Testing Sales Market Share by Countries in 2019Table North America Direct-To-Consumer (DTC) Genetic Testing Revenue ($) by Countries (2015-2020)Table North America Direct-To-Consumer (DTC) Genetic Testing Revenue Market Share by Countries (2015-2020)Figure North America Direct-To-Consumer (DTC) Genetic Testing Revenue Market Share by Countries in 2015Figure North America Direct-To-Consumer (DTC) Genetic Testing Revenue Market Share by Countries in 2019Figure United States Direct-To-Consumer (DTC) Genetic Testing Sales and Growth Rate (2015-2020)Figure Canada Direct-To-Consumer (DTC) Genetic Testing Sales and Growth Rate (2015-2020)Figure Mexico Direct-To-Consumer (DTC) Genetic Testing Sales and Growth (2015-2020)Figure Europe Direct-To-Consumer (DTC) Genetic Testing Revenue ($) Growth (2015-2020)Table Europe Direct-To-Consumer (DTC) Genetic Testing Sales by Countries (2015-2020)Table Europe Direct-To-Consumer (DTC) Genetic Testing Sales Market Share by Countries (2015-2020)Figure Europe Direct-To-Consumer (DTC) Genetic Testing Sales Market Share by Countries in 2015Figure Europe Direct-To-Consumer (DTC) Genetic Testing Sales Market Share by Countries in 2019Table Europe Direct-To-Consumer (DTC) Genetic Testing Revenue ($) by Countries (2015-2020)Table Europe Direct-To-Consumer (DTC) Genetic Testing Revenue Market Share by Countries (2015-2020)Figure Europe Direct-To-Consumer (DTC) Genetic Testing Revenue Market Share by Countries in 2015Figure Europe Direct-To-Consumer (DTC) Genetic Testing Revenue Market Share by Countries in 2019Figure Germany Direct-To-Consumer (DTC) Genetic Testing Sales and Growth Rate (2015-2020)Figure UK Direct-To-Consumer (DTC) Genetic Testing Sales and Growth Rate (2015-2020)Figure France Direct-To-Consumer (DTC) Genetic Testing Sales and Growth Rate (2015-2020)Figure Italy Direct-To-Consumer (DTC) Genetic Testing Sales and Growth Rate (2015-2020)Figure Spain Direct-To-Consumer (DTC) Genetic Testing Sales and Growth Rate (2015-2020)Figure Russia Direct-To-Consumer (DTC) Genetic Testing Sales and Growth Rate (2015-2020)Figure Asia-Pacific Direct-To-Consumer (DTC) Genetic Testing Revenue ($) and Growth (2015-2020)Table Asia-Pacific Direct-To-Consumer (DTC) Genetic Testing Sales by Countries (2015-2020)Table Asia-Pacific Direct-To-Consumer (DTC) Genetic Testing Sales Market Share by Countries (2015-2020)Figure Asia-Pacific Direct-To-Consumer (DTC) Genetic Testing Sales Market Share by Countries in 2015Figure Asia-Pacific Direct-To-Consumer (DTC) Genetic Testing Sales Market Share by Countries in 2019Table Asia-Pacific Direct-To-Consumer (DTC) Genetic Testing Revenue ($) by Countries (2015-2020)Table Asia-Pacific Direct-To-Consumer (DTC) Genetic Testing Revenue Market Share by Countries (2015-2020)Figure Asia-Pacific Direct-To-Consumer (DTC) Genetic Testing Revenue Market Share by Countries in 2015Figure Asia-Pacific Direct-To-Consumer (DTC) Genetic Testing Revenue Market Share by Countries in 2019Figure China Direct-To-Consumer (DTC) Genetic Testing Sales and Growth Rate (2015-2020)Figure Japan Direct-To-Consumer (DTC) Genetic Testing Sales and Growth Rate (2015-2020)Figure South Korea Direct-To-Consumer (DTC) Genetic Testing Sales and Growth Rate (2015-2020)Figure Australia Direct-To-Consumer (DTC) Genetic Testing Sales and Growth Rate (2015-2020)Figure India Direct-To-Consumer (DTC) Genetic Testing Sales and Growth Rate (2015-2020)Figure Southeast Asia Direct-To-Consumer (DTC) Genetic Testing Sales and Growth Rate (2015-2020)Figure Middle East and Africa Direct-To-Consumer (DTC) Genetic Testing Revenue ($) and Growth (2015-2020) continued

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NOTE: Our report does take into account the impact of coronavirus pandemic and dedicates qualitative as well as quantitative sections of information within the report that emphasizes the impact of COVID-19.

As this pandemic is ongoing and leading to dynamic shifts in stocks and businesses worldwide, we take into account the current condition and forecast the market data taking into consideration the micro and macroeconomic factors that will be affected by the pandemic.

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Analyzing Impacts of Covid-19 on Direct-To-Consumer (DTC) Genetic Testing Market Effects, Aftermath and Forecast To 2026 - Owned

As the government considers plans to carry out mass coronavirus testing, Sky News looks at the different types of tests available.

There are two different strands of testing - one is to find out if a person currently has COVID-19 and the other determines if they have had it and have built up antibodies.

PCR testing and antigen testing (often confused as the same kind of test) are different methods of testing, but both ascertain whether a person has COVID-19 at the time.

PCR testing

Polymerase chain reaction (PCR) testing is currently the most common form of testing in the UK and is seen as fairly reliable.

A swab is used to collect an RNA sample (the nucleic acid that converts DNA into proteins) from the patient's tonsils and inside their nose.

RNA is collected as it carries the genetic information of this specific virus.

This is then sent to a laboratory where the sample is heated and cooled so it multiplies into larger quantities of DNA.

Bioscientists can then see whether the SARS-CoV-2 virus (the virus that causes COVID-19) is present.

Because of the process, PCR tests are taking about two days and are currently only available to people with symptoms, those in households with symptoms, and key workers.

90-minute PCR test

Machines that can deliver on-the-spot genetic testing are being used to collect RNA for PCR testing, which can also detect the common flu.

The RNA, taken using swab samples placed into a cartridge, is inserted into the machine which carries out a PCR test and then identifies if the virus is present.

A successful pilot test across eight London hospitals using British start-up DnaNudge's machines is being rolled out to NHS hospitals, with the plan to deliver 5.8m tests in the next few months.

20-minute saliva test

Loop-mediated Isothermal Amplification (LAMP) is a similar process to PCR testing but produces many more viral RNA copies at a constant temperature instead of heating and cooling.

A swab is used to take samples from the nose or throat, or mucus from hard coughing can also be used.

The samples are then placed in vials of reagents (substances that produce a chemical reaction to detect the RNA), then heated in a special machine for 20 minutes.

The machine then analyses the sample and confirms if there is any SARS-CoV-1 RNA.

Health Secretary Matt Hancock announced on 3 September that the LAMP test would be part of a 500m funding boost after a successful pilot across Hampshire hospitals, GP test hubs and care homes.

No-swab saliva test

Patients can do this test at home by collecting about two millimetres of saliva into a sample pot, then sending it off to a laboratory.

The sample gets tested using LAMP technology in a lab and the result is then texted to the person.

It still takes about 48 hours but there is no need for a patient to leave their home or stick a swab down their throat or up their nose.

A government-funded trial in Southampton has been expanded from GPs to the city's university staff and students, and four schools.

Antigen testing

These tests look for antigens - proteins that are produced by the body when it recognises a foreign structure, such as the COVID-19 virus.

Antigens can easily be detected in saliva and laboratory testing is not necessary, so can be done in places such as care homes and without a medical professional.

Results can be provided more quickly than PCR tests, with some systems already available and dozens more being developed.

20-second test

Released this week, the Virolens system uses a portable machine which creates a microscopic holographic image to detect the virus in saliva samples in 20 seconds.

Developed by British companies iAbra and TT Electronics, it uses a digital camera attached to a microscope, which then runs data through a computer that can identify the virus from other cells.

The device has been trialled at Heathrow Airport, whose chief executive, John Holland-Kaye, has urged the government to fast-track the technology to be used across the UK.

Antibody testing

Not currently available to the general public on the NHS, antibody testing looks at whether your body has produced any antibodies to fight against the virus.

A blood test is taken from a person who has had COVID-19 symptoms that have disappeared three to four weeks before.

A lab test then takes a unique protein the virus makes and tests whether any antibodies in the blood bind to that protein.

There are pin-prick tests in development which would allow a person to submit their own blood test, but these have not been rolled out yet.

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Unlike other diseases, the UK government and the World Health Organisation agree there is currently no evidence that someone with antibodies will not catch COVID-19 again in the future.

This is why the government has not rolled antibody testing out to the general public, although tests are available privately.

NHS staff, care staff and some people in care homes and in hospital are having antibody tests.

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Coronavirus: What are the different types of COVID-19 tests? - Sky News

This Breast Cancer Predictive Genetic Testing Market report 2020 delivers in-depth impression, describing about the Product/Industry Scope and expands market insights and forecast to 2024. It shows market data by industry drivers, restraints and opportunity, also analyses the market status, industry share, size, future trends and growth rate of market. Breast Cancer Predictive Genetic Testing market report is categorized based application, end-user, technology, the types of product/service, and others, as well as regions. Additionally, the report comprehends the calculated expected CAGR of the Breast Cancer Predictive Genetic Testing market derivative from previous records about the Breast Cancer Predictive Genetic Testing market and current market trends organized with future developments.

Final Report will add the analysis of the impact of COVID-19 on this industry.

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The report mainly studies the Breast Cancer Predictive Genetic Testing market size, recent trends and development status, as well as investment opportunities, market dynamics (such as driving factors, restraining factors), and industry news (like mergers, acquisitions, and investments). Technological innovation and advancement will further optimize the performance of the product, making it more widely used in downstream applications. Moreover, Porters Five Forces Analysis (potential entrants, suppliers, substitutes, buyers, industry competitors) provides crucial information for knowing the Breast Cancer Predictive Genetic Testing market.

Key players in the global Breast Cancer Predictive Genetic Testing market covered in Chapter 4:

Global Breast Cancer Predictive Genetic Testing Industry 2020 Market Research Report also provides exclusive vital statistics, data, information, trends and competitive landscape details in this niche sector.

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Scope of the Breast Cancer Predictive Genetic Testing Market Report:

Geographically, the detailed analysis of consumption, revenue, market share and growth rate, historic and forecast (2015-2024) of the following regions are covered in Chapter 5, 6, 7, 8, 9, 10, 13:

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Most important Types of Breast Cancer Predictive Genetic Testing products covered in this report are:

On the basis of the end users/applications, this report focuses on the status and outlook for major applications/end users, consumption (sales), market share and growth rate for each application, including:

Global Breast Cancer Predictive Genetic Testing Market providing information such as company profiles, product picture and specification, capacity, production, price, cost, revenue and contact information. Upstream raw materials and equipment and downstream demand analysis are also carried out. The Global Breast Cancer Predictive Genetic Testing market development trends and marketing channels are analyzed. Finally, the feasibility of new investment projects is assessed and overall research conclusions offered.

Some of the key questions answered in this report:

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There are 13 Chapters to thoroughly display the Video Smoke Detection market. This report included the analysis of market overview, market characteristics, industry chain, competition landscape, historical and future data by types, applications and regions.

Chapter 1: Video Smoke Detection Market Overview, Product Overview, Market Segmentation, Market Overview of Regions, Market Dynamics, Limitations, Opportunities and Industry News and Policies.

Chapter 2: Video Smoke Detection Industry Chain Analysis, Upstream Raw Material Suppliers, Major Players, Production Process Analysis, Cost Analysis, Market Channels and Major Downstream Buyers.

Chapter 3: Value Analysis, Production, Growth Rate and Price Analysis by Type of Video Smoke Detection.

Chapter 4: Downstream Characteristics, Consumption and Market Share by Application of Video Smoke Detection.

Chapter 5: Production Volume, Price, Gross Margin, and Revenue ($) of Video Smoke Detection by Regions (2014-2019).

Chapter 6: Video Smoke Detection Production, Consumption, Export and Import by Regions (2014-2019).

Chapter 7: Video Smoke Detection Market Status and SWOT Analysis by Regions.

Chapter 8: Competitive Landscape, Product Introduction, Company Profiles, Market Distribution Status by Players of Video Smoke Detection.

Chapter 9: Video Smoke Detection Market Analysis and Forecast by Type and Application (2019-2024).

Chapter 10: Market Analysis and Forecast by Regions (2019-2024).

Chapter 11: Industry Characteristics, Key Factors, New Entrants SWOT Analysis, Investment Feasibility Analysis.

Chapter 12: Market Conclusion of the Whole Report.

Chapter 13: Appendix Such as Methodology and Data Resources of This Research.

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Breast Cancer Predictive Genetic Testing Market Growth Insight, Size, Industry Trends, Share, Emerging Technologies, Share, Competitive, Regional, And...

Many people are surprised to learn how many decisions need to be made throughout pregnancy. Where do I want to receive my prenatal care? What lifestyle changes am I going to make to stay as healthy as possible?

Another big decision that needs to be made is about genetic screening during pregnancythere are so many options, and it can feel overwhelming. But take heart, mama. We promise you'll figure it out. Especially because you don't have to do it alone.

It's important to know that genetic screening is optional during pregnancy. Whatever feels right for you and your baby is usually best. New information on genetics comes out all the time. If you are thinking about having prenatal genetic screening or testing, talk to your provider first for the most up-to-date information and specific guidance based on your personal story.

According to the American College of Obstetricians and Gynecologists (ACOG), "prenatal genetic screening gives parents-to-be' information about whether their fetus has a certain genetic disorder."

Screenings are not diagnostic. This means that the results are not definitive ("The baby does or does not have Down syndrome,") but rather a prediction of chance ("There is a higher or lower than normal chance that the baby could have Down syndrome.")

If tests come back indicating that there is a high chance of abnormality, your provider may recommend diagnostic testing which can give a definitive yes or no result (more on that soon).

There are two main types of prenatal genetic testing: prenatal screening test and prenatal diagnostics test.

Prenatal screening tests:

Prenatal genetic screening tests can identify whether your baby is more or less likely to have certain birth defects, most stemming from genetic disorders. These are not definitive tests, they just tell you the chances. If results indicate an increased risk, your provider may talk to you about doing a diagnostic test.

Here are some common prenatal genetic screening tests:

Noninvasive prenatal testing (NIPT), also called cell-free fetal DNA testing. This can be done between weeks 10 and 20. It assesses the chances of chromosomal abnormalities, such as Down syndrome (trisomy 21), Patau syndrome (trisomy 13), Edwards syndrome (trisomy 18) and certain single-gene disorders associated with abnormalities of the skeleton, bones or heart. This test can also determine the sex of your baby if you'd like to know. The results take about a week to come in.

First-trimester combined screening. This is an optional test that is offered between weeks 11 and 14. The test involves taking a blood sample from you along with doing an ultrasound that looks at certain aspects of the baby's development. Specifically, the ultrasound looks at the clear space in the tissue at the back of the baby's neckthe size of this space, along with the information provided by the blood test, can help identify a higher chance for Down syndrome.

Second Trimester screening. Similar to the first trimester screening, your provider will take a blood test called a quad screen. This will measure four substances in your blood which indicate the chance of carrying a baby with chromosomal defects like Down syndrome, as well as neural tube defects.

Here are some common prenatal diagnostic tests:

Your provider may recommend a diagnostic test if your screening indicates an elevated chance of abnormality, or if other factors like family and medical history warrant it. These are more invasive and the only way to be sure of a diagnosis.

Chorionic Villus Sampling (CVS). CVS tests for certain disorders and chromosomal abnormalities in the fetus by looking at the chorionic villi, which are wisps of placental tissue that contain your baby's DNA. It can be done as early as 10 weeks. Placental tissue is extracted from your uterus by a catheter inserted into your cervix or by needle into the abdomen. The tissue will be genetically analyzed for certain disorders.

The procedure carries a small (0.35%) risk of miscarriage. It may sting and induce some cramping, but after a day of rest, you are cleared to resume normal activity. The benefit of CVS is that it can be done earlier in the pregnancy than an amniocentesis.

Amniocentesis. An amniocentesis (often called an amnio) is a procedure to sample the fluid that surrounds the baby. This amniotic fluid contains your baby's DNA, so it can be used to test for genetic disorders. It is usually performed between weeks 15 and 20 and does carry some risks, so it is important to be informed about them. According to the Society for Maternal-Fetal Medicine, amniocentesis is associated with a miscarriage rate of 1 in 300 to 500.

With most tests, there is a potential for false-positive results (when a positive test is wrong) and false-negative results (when a negative test is wrong). We recommend reaching out to your provider, they can give you more information on the rates of false-positive and false-negative test results and compare other options.

The risk associated with genetic testing can depend on the test you get. For the prenatal screening tests, the risks are limited due to its less invasive process (blood test and ultrasound). Many of the risks associated with genetic testing involve emotional, social and financial consequences of the test results. These are just as important to keep in mind (more on these in a bit).

For diagnostic screening, there is a small but real risk of miscarriage due to it being a more invasive procedure. This is because they need a sample of amniotic fluid or tissue from the fetus.

If you are trying to decide if you'd like to have genetic screening or testing, here are some questions to ask your provider:

There are also genetic specialists who may have even more information about the prenatal genetic testing than your provider does. Do not hesitate to request an appointment with a genetic specialist to discuss any of your questions further.

Mama, trust yourself. People are going to have all kinds of advice regarding genetic screeningsand it's okay to listen if you want to. But ultimately, you have to make the best decision for you. This is a great time to tune out the noise, get evidence-based and personalized information from your provider, and then listen to your gut. There is no right answer here, so doing what feels right is totally appropriate.

Some women choose to have all the available tests done, while others decline all of them. The majority of women probably fall somewhere in the middle.

Mama, it's all okay.

Here's a way to make the decision: Think about what you are going to do with the information you receive. Consider this:

If the test comes back saying your baby has a very low chance of having a chromosomal abnormality, will that help you to feel more relaxed during your pregnancy? Or would you rather not think about this knowledge one way or the other?

If the test comes back saying that your baby has a high chance of having a chromosomal abnormality, will you then choose to have an amniocentesis to get more reliable information?

If you do choose an amniocentesis, and it reveals that your baby does indeed have a chromosomal abnormality, does that impact your decision-making moving forward? Will you, for example, appreciate knowing this information so you can begin to make special plans for caring for the baby? Will you choose to terminate the pregnancy? If the answer to both of those questions is no, perhaps you may not want to have the testing at all.

Again, it's complicated. But just like with all of pregnancy and parenting, there is no one right way to do things. The world is full of ideas and judgment, but in these moments, focus on your needs and desires and your provider's guidance.

A portion of this article has been excerpted from The Motherly Guide to Becoming Mama.

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Should I get prenatal genetic screening? The most common questions, answered. - Motherly Inc.

While identifying new genetic targets and developing novel drugs is important for the future of non-small cell lung cancer (NSCLC), more emphasis should be put on improving patient access to existing targeted treatments, according to Dr. Nathan A. Pennell.

In an interview with OncLive, CUREs sister publication, Pennell, an associate professor in thedepartment of medicine and director of the lung cancer medical oncology program at theTaussig Cancer Institute of Cleveland Clinic,spoke about current and emerging treatment options in NSCLC, including immunotherapy combinations and personalized treatments involving T cells.

But when it comes to the future, Pennell said, identifying targetable genetic alterations in patients and treating them with existing drugs should be a key area of focus.

Studies have shown that probably fewer than half of people with targetable genetic alterations in lung cancer are being identified and never receiving treatment for this, Pennell said, and I think before we move on to the next exciting drug or the next exciting marker, we should spend a little time making sure that every patient is identified and gets access to the treatments that we already have.

Transcription:

We've made such tremendous progress over the last decade. And just it seems like every year, new targets are emerging and new drugs are getting approved. And so, the speed with which we're moving from discovery to actually treating people has been staggering, and I hope that continues.

There continue to be very promising emerging biomarkers including KRAS mutations, again, HER2 mutations. There certainly is lots of room for improving the efficacy of immunotherapy, which can be tremendously life changing and potentially even curative in patients with metastatic disease. But unfortunately, it's only really working in a minority of patients and so lots of room to be improved in that.

I think combinations of immunotherapy and perhaps even more personalized immunotherapy, using T-cells that recognize individual patients tumors, may be the future for this, or personalized tumor vaccines.

But honestly, instead of just focusing on discovering new treatments and new targets, I think we should focus more on applying what we already know. So, we have tremendous treatments for patients with specific subgroups of lung cancer, but studies have shown that probably fewer than half of people with targetable genetic alterations in lung cancer are being identified and never receiving treatment for this. And I think before we move on to the next exciting drug or the next exciting marker, we should spend a little time making sure that every patient is identified and gets access to the treatments that we already have.

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Personalized Medicine, Genetic Testing Could Shape the Future of Non-Small Cell Lung Cancer - Curetoday.com

An employee works in a protective suit in a laboratory of the biotech company Qiagen in Germany, September 8, 2020.

Fabian Strauch | picture alliance | Getty Images

German genetic testing companyQiagenannounced Tuesday that it plans to launch a new antigen test for the coronavirus that it says could eventually be deployed in airports and stadiums if it receives the appropriate authorizations.

The company said it plans to launch two versions of the antigen test in the U.S. later this year: one version that's meant to be processed in a clinical laboratory and another that's portable and can be processed at point of care. The company has not yet applied for emergency use authorization from the Food and Drug Administration but said it plans to.

If the test, called theAccess Antigen Test, is granted FDA authorization for point-of-care use and if it's waived from the requirements under the Clinical Laboratory Improvement Amendments, Qiagen said, the test could be used in high-volume settings such as airports and stadiums to test people with symptoms. Rapidly testing symptomatic people could become increasingly important in the fall and winter as seasonal influenza, which causes many of the same early symptoms as seen in Covid-19, spreads in the Northern Hemisphere.

"The portable test offers a new combination of speed and scale that marks an important step towards decentralized mass testing that health authorities all over the world have been urgently seeking," the company said in a release.

The test, which wasdeveloped in collaboration withAustralian diagnostics company Ellume, can screen up to eight nasal-swab samples simultaneously, the company said. Administrators of the test use a small digital platform, called an eHub, which was launched in August with Qiagen's antibody test, to process the nasal swabs.

The platform can yield results in less than 15 minutes, the company said, and can process an average of about 30 swab samples every hour. Qiagen added that the test correctly diagnoses a positive coronavirus infection 90% of the time and correctly diagnoses a negative result 100% of the time. The company did not elaborate on the methods used to arrive at the accuracy conclusions.

The company has not yet disclosed a price point for the test, but Qiagen CEO Thierry Bernard called the tests "cost-effective." Qiagen also did not disclose details on how many tests it will be able to manufacture.

In a statement, Bernard added that the antigen tests are meant to supplement, not replace, the molecular, or PCR, tests, which are the most accurate tests on the market. PCR tests, however, are dependent on a strained supply chain of technical laboratory equipment, need to be processed by trained scientists and can take hours or days to yield results.

The company added that it will also apply for certification in Europe.

"The Access Antigen Test is fast, easy to use and cost-effective and will be a valuable tool to address the so far unmet high-volume testing needs for SARS-CoV-2 antigens in situations where time is of the essence," Bernard said in a statement. "It will deliver highly accurate results and will complement the gold-standard PCR tests used for detection of active COVID-19 infection. PCR tests offer a high level of diagnostic accuracy but are time-consuming and lab-bound."

CNBC's Meg Tirrell contributed to this report.

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Qiagen to launch rapid coronavirus test it says could be used in airports and stadiums - CNBC

Fort Collins, Colorado The Global Breast Cancer Predictive Genetic Testing Market research report offers insightful information on the Global Breast Cancer Predictive Genetic Testing market for the base year 2019 and is forecast between 2020 and 2027. Market value, market share, market size, and sales have been estimated based on product types, application prospects, and regional industry segmentation. Important industry segments were analyzed for the global and regional markets.

The effects of the COVID-19 pandemic have been observed across all sectors of all industries. The economic landscape has changed dynamically due to the crisis, and a change in requirements and trends has also been observed. The report studies the impact of COVID-19 on the market and analyzes key changes in trends and growth patterns. It also includes an estimate of the current and future impact of COVID-19 on overall industry growth.

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The report has a complete analysis of the Global Breast Cancer Predictive Genetic Testing Market on a global as well as regional level. The forecast has been presented in terms of value and price for the 8 year period from 2020 to 2027. The report provides an in-depth study of market drivers and restraints on a global level, and provides an impact analysis of these market drivers and restraints on the relationship of supply and demand for the Global Breast Cancer Predictive Genetic Testing Market throughout the forecast period.

The report provides an in-depth analysis of the major market players along with their business overview, expansion plans, and strategies. The main actors examined in the report are:

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In market segmentation by types of Global Breast Cancer Predictive Genetic Testing, the report covers-

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(Covid-19 Impact)Breast Cancer Predictive Genetic Testing Market Size is Thriving Worldwide 2020 | Growth and Profit Analysis, Forecast by 2027 - The...

New Jersey, United States, The Preimplantation Genetic Testing Market report 2020 provides a detailed impression, describe the product industry scope and the market expanded insights and forecasts up to 2027. It shows market data according to industry drivers, restraints and opportunities, analyzes the market status, the industry share, size, future Trends and growth rate of the market. The Preimplantation Genetic Testing Market report is categorized by application, end user, technology, product / service types, and other, as well as by region. In addition, the report includes the calculated expected CAGR of chitosan acetate-market derivative from the earlier records of the Preimplantation Genetic Testing Market, and current market trends, which are organized with future developments.

Preimplantation Genetic Testing Market was valued at USD 401.49 million in 2019 and is projected to reach USD 796.89 million by 2027, growing at a CAGR of 9.65% from 2020 to 2027.

1.Preimplantation Genetic Testing Market, By Technology:

Next-Generation Sequencing Polymerase Chain Reaction Fluorescence in Situ Hybridization Comparative Genomic Hybridization Single-Nucleotide Polymorphism

2.Preimplantation Genetic Testing Market, By Procedure Type:

Preimplantation Genetic Screening Preimplantation Genetic Diagnosis

3.Preimplantation Genetic Testing Market, By Application:

Aneuploidy Structural Chromosomal Abnormalities Translocations Deletions Duplications Inversions Single Gene Disorders X-Linked Disorders HLA Typing Gender Identification

4.Preimplantation Genetic Testing Market, By Products And Services:

Reagents and Consumables Instruments Software and Services

5.Preimplantation Genetic Testing Market, By End User:

Maternity Centers & Fertility Clinics Hospitals, Diagnostic Labs, and Service Providers Research Laboratories & Academic Institutes

The report provides detailed coverage of the Preimplantation Genetic Testing Market, including structure, definitions, applications, and Industry Chain classifications. The Preimplantation Genetic Testing Market analysis is provided for the international markets including development trends, competitive landscape analysis, investment plan, business strategy, opportunities and development status of key regions. Development policies and plans are discussed and manufacturing processes and cost structures analyzed. This report also includes information on import / export consumption, supply and demand, costs, industry share, policy, Price, Sales and gross margins.

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Preimplantation Genetic Testing Market forecast up to 2027, with information such as company profiles, product picture and specification, capacity production, price, cost, revenue, and contact information. Upstream raw materials and equipment as well as downstream demand analyses are also carried out. The Preimplantation Genetic Testing Market size, development trends and marketing channels are analyzed. Finally, the feasibility of new investment projects is assessed and general research results are offered.

The Preimplantation Genetic Testing Market was created on the basis of an in-depth market analysis with contributions from industry experts. The report covers the growth prospects in the coming years and the discussion of the main providers.

To understand how the effects of COVID-19 are addressed in this report. A sample copy of the report is available at https://www.verifiedmarketresearch.com/product/Preimplantation-Genetic-Testing-Market/?utm_source=TDC&utm_medium=001

Verified Market Researchis a leading Global Research and Consulting firm servicing over 5000+ customers. Verified Market Research provides advanced analytical research solutions while offering information enriched research studies. We offer insight into strategic and growth analyses, Data necessary to achieve corporate goals, and critical revenue decisions.

Our 250 Analysts and SMEs offer a high level of expertise in data collection and governance use industrial techniques to collect and analyze data on more than 15,000 high impact and niche markets. Our analysts are trained to combine modern data collection techniques, superior research methodology, expertise, and years of collective experience to produce informative and accurate research.

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Preimplantation Genetic Testing Market is Thriving Worldwide 2020 | Trends, Growth and Profit Analysis, Forecast by 2027 - The Daily Chronicle

As Marina Giokas sails the Strait of Georgia off the southwestern coast of B.C., her phone rings. Despite being on the high seas, the West Vancouver communications and finance consultants cell signal is clear as a bell.

Youve got to love technology, she quips.

Giokas means that in more ways than one. Since 2018, Giokas has depended on nutrigenomics the way genes interact with different foods and nutrients to personalize her diet.

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Since taking a DNA test through Vancouver company dnaPower Inc., Giokas has been using the companys resulting personalized report to discover the best diet for her genetic makeup.

It goes deep, she says of the service. Its about what your body does not tolerate and what it needs more of.

Marina Giokas, pictured here with her boat in West Vancouver, uses a personalized nutrigenomics report to guide her diet choices.

Darryl Dyck / THE GLOBE AND MAIL

Giokas now eats more fruit and vegetables, washing them thoroughly to remove any pesticides or chemicals. And shes said goodbye to supplements. Instead, Giokas has replaced them with the B vitamins the report said she needed.

After a tough year of treatment for breast cancer in 2017/2018, shes hoping these simple changes to her diet and exercise regime will keep her feeling healthier.

Personalized diet and wellness plans based on DNA have grown in popularity in recent years as Canadians look for new, tech-savvy ways to improve their health. According to Statistics Canada, 63.1 per cent of Canadians are now considered either overweight or obese.

Health experts have long known that a one-size-fits-all approach to diet doesnt work. One person might drop 20 pounds on a high fat diet or low carb diet, while the scales needle doesnt budge for someone else who eats the same foods. So how can we know in advance which side of the equation someone will land on?

Clients of dnaPower Inc. receive a swab to collect their DNA, then send it back through the mail.

Darryl Dyck / THE GLOBE AND MAIL

Lois Nahirney, president and founder of dnaPower, says she gets asked that question all the time, particularly in relation to the popular low-carb, high-fat Ketogenic diet. When people ask her if its right for them, she responds, It depends.

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Im looking at a report right now that shows this person has a problem with dietary saturated fats. Thats someone who would have some challenges on a Keto diet, she explains. Based on this persons DNA, the company would likely recommend eating unsaturated fats found in flaxseed oil, hemp seed and walnuts. Leafy greens would get a thumbs up too, while dairy and fatty meats would go on the no-no list.

The idea behind nutrigenomics is that by understanding your unique DNA, you can match your diet choices to how your body processes nutrients. For example, research has linked specific genes, or groups of genes, to conditions like lactose sensitivity, food allergies, gluten intolerance and caffeine sensitivity. Nutrigenomics may reveal that someone should stay away from too much coffee, eat more healthy fats or specific vitamin-rich foods, for example.

Taking a DNA test is as easy as sticking a swab in your cheek and then mailing it back, says Nahirney. Results still come back within two to six weeks, and clients then can go over the results with a dnaPower dietitian. The cost is $299. (DNA-based reports addressing other wellness areas like exercise and brain health are also available for an added fee.)

Lois Nahirney, founder and CEO of dnaPOWER, at her home office in Vancouver.

Darryl Dyck / THE GLOBE AND MAIL

dnaPower is only one of many companies using biometric readings to create targeted health and diet plans. Theres DNAfit from the U.K. which provides everything from sleep and stress reports to personalized diets and meal plans. Milwaukee, WI-based GenoPalate offers personalized recipes built from clients genetic results, and Torontos Nutrigenomix promises a way to eat according to your genes.

But the question for most potential clients might be: Does it work?

Kristin Kirkpatrick, a registered dietitian and wellness manager for the Cleveland Clinic Wellness Institute, says she has seen firsthand how personalized nutrigenomic testing has helped patients commit to their diet once they understand which diets and exercise programs may work best for them. Some have switched from a Keto diet to a Mediterranean-based one. Others have swapped resistance training for more aerobic exercise.

Still, while DNA testing for wellness offers the potential for addressing more serious health conditions in the future, theres more research to be done first, she says.

Though DNA-based diets are trending and gaining valuable evidence through studies, we are not ready for prime time quite yet for recommending to all populations, she says, mentioning that people may also be unable to afford genetic testing since it is not typically covered by insurance.

But Giokas is glad she took the plunge and shelled out for the test, even if she falls off the wagon from time to time, tempted by cheese and popcorn. Having her DNA-based health plan gives her the motivation to get back on track.

Im amazed just how simple it is to take control of your health once you have the information, she says.

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Diet by DNA: How tech is changing what it means to eat healthy - The Globe and Mail

New Jersey, United States, The Direct-To-Consumer (DTC) Genetic Testing Market report 2020 provides a detailed impression, describe the product industry scope and the market expanded insights and forecasts up to 2027. It shows market data according to industry drivers, restraints and opportunities, analyzes the market status, the industry share, size, future Trends and growth rate of the market. The Direct-To-Consumer (DTC) Genetic Testing Market report is categorized by application, end user, technology, product / service types, and other, as well as by region. In addition, the report includes the calculated expected CAGR of chitosan acetate-market derivative from the earlier records of the Direct-To-Consumer (DTC) Genetic Testing Market, and current market trends, which are organized with future developments.

Global Direct-to-Consumer (DTC) Genetic Testing Market was valued at USD 789.92 Million in 2018 and is projected to reach USD 2,361.12 Billion by 2026, growing at a CAGR of 14.59% from 2019 to 2026.

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Global Direct-to-Consumer (DTC) Genetic Testing Market, By Test Type

Predictive Testing Carrier Testing Nutrigenomics Testing Others

Global Direct-to-Consumer (DTC) Genetic Testing Market, By Technology

Single Nucleotide Polymorphism Chips Whole Genome Sequencing Targeted Analysis

The report provides detailed coverage of the Direct-To-Consumer (DTC) Genetic Testing Market, including structure, definitions, applications, and Industry Chain classifications. The Direct-To-Consumer (DTC) Genetic Testing Market analysis is provided for the international markets including development trends, competitive landscape analysis, investment plan, business strategy, opportunities and development status of key regions. Development policies and plans are discussed and manufacturing processes and cost structures analyzed. This report also includes information on import / export consumption, supply and demand, costs, industry share, policy, Price, Sales and gross margins.

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Direct-To-Consumer (DTC) Genetic Testing Market forecast up to 2027, with information such as company profiles, product picture and specification, capacity production, price, cost, revenue, and contact information. Upstream raw materials and equipment as well as downstream demand analyses are also carried out. The Direct-To-Consumer (DTC) Genetic Testing Market size, development trends and marketing channels are analyzed. Finally, the feasibility of new investment projects is assessed and general research results are offered.

The Direct-To-Consumer (DTC) Genetic Testing Market was created on the basis of an in-depth market analysis with contributions from industry experts. The report covers the growth prospects in the coming years and the discussion of the main providers.

To understand how the effects of COVID-19 are addressed in this report. A sample copy of the report is available at https://www.verifiedmarketresearch.com/product/Direct-To-Consumer-DTC-Genetic-Testing-Market/?utm_source=TDC&utm_medium=001

Verified Market Researchis a leading Global Research and Consulting firm servicing over 5000+ customers. Verified Market Research provides advanced analytical research solutions while offering information enriched research studies. We offer insight into strategic and growth analyses, Data necessary to achieve corporate goals, and critical revenue decisions.

Our 250 Analysts and SMEs offer a high level of expertise in data collection and governance use industrial techniques to collect and analyze data on more than 15,000 high impact and niche markets. Our analysts are trained to combine modern data collection techniques, superior research methodology, expertise, and years of collective experience to produce informative and accurate research.

Mr. Edwyne Fernandes

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Direct-To-Consumer (DTC) Genetic Testing Market is Thriving Worldwide 2020 | Trends, Growth and Profit Analysis, Forecast by 2027 - The Daily...

The GlobalGenetic Testing Market report contains a complete analysis of the different aspects of the market such as the market size, key marketing regions, key players, leading firms, market structure, segmentation, revenue generation, demand, research, and development, and top marketing strategies. The Genetic Testing Market report provides comprehensive data for the latest market entrants. Furthermore, the explosion delivers a market summary, SWOT analysis, and total market share.

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List ofTop Key Playersof Genetic Testing Market:

HI GeneRegulatoryAnnoroadSinoGenoMaxGenePlanetCounsyl, Inc.RepconexNatera, IncBiomarkerGeeppine360Jiyin23andMe, IncCapitalBioBiomedlabGene by GeneUnited GeneGeneDxFind Bio-TechAiyin GeneCourtagen Life SciencesAgenGeneTestsAsper BiotechPathway GenomicsNovogeneBGIGene KangBerry GenomicsAijiyin

Genetic Testing Market report also covers a comprehensive analysis of the competitive landscape, upcoming development trends, and key manufacturers of the industry. The recovery from COVID-19 is likewise being shared through this report discussed with the expertise in the industry. Besides the summary, the report shares a huge region of knowledge that has comprehensive evolution, definitions & classifications, with expert opinion. Also, itll mention Capacity, Amount, Revenue, Cost, and Gross margin of profit, growth rate, Import, Export, Market Share, and Technological Developments.

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Genetic Testing Market Segment by Type:

CancerCystic fibrosisSickle cell anemiaDuchenne muscular dystrophyAlzheimer diseaseThalassemiaHuntington diseaseOthers

Genetic Testing Market segment by Application:

Newborn screeningDiagnostic testingCarrier testingPreimplantation genetic diagnosisPrenatal diagnosisPredictive and presymptomatic testingPharmacogenomics

Important Features that are under Offering and Key Highlights of the Reports:

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The Genetic Testing Market Research report delivers an all-inclusive overview of the competitive landscape along with an in-depth analysis of the company profiles, revenue estimation, and gross margin profits, and market size and share. Furthermore, the report studies the strategic initiatives taken by the companies to expand their customer base, market size. It also evaluates key industry trends and sales and distribution channels.

The Genetic Testing Market Report Can Answer The Following Questions:

Reasons To Buy Genetic Testing Market Research Report:

Table of Contents

1. Research Methodology 2. Executive Summary 3.Market Overview 3.1. Definition 3.2. Genetic Testing Industry Market Value Chain Analysis 3.3. Porters 5 Forces 3.4. Regulations 4. Market Dynamics 4.1. Introduction 4.2. Drivers 4.3. Constraints 4.4. Trends 5. Global Genetic Testing Market Segmentation, Forecasts, and Trends by Application 6. Global Genetic Testing Market Segmentation, Forecasts, and Trends by Technology 7. Global Genetic Testing Market Segmentation, Forecasts, and Trends by Region 8. Competitive Intelligence 8.1. Company Market Share Analysis 9. Company Profiles 10. Investment Opportunities

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Global Genetic Testing Market By Covid-19 Impact Analysis, Global Industry Report: Overview with Product Scope, Opportunities Risk, Top Participants,...

Trusted Business Insights answers what are the scenarios for growth and recovery and whether there will be any lasting structural impact from the unfolding crisis for the Direct-to-Consumer Genetic Testing market.

Trusted Business Insights presents an updated and Latest Study on Direct-to-Consumer Genetic Testing Market 2019-2029. The report contains market predictions related to market size, revenue, production, CAGR, Consumption, gross margin, price, and other substantial factors. While emphasizing the key driving and restraining forces for this market, the report also offers a complete study of the future trends and developments of the market.The report further elaborates on the micro and macroeconomic aspects including the socio-political landscape that is anticipated to shape the demand of the Direct-to-Consumer Genetic Testing market during the forecast period (2019-2029).It also examines the role of the leading market players involved in the industry including their corporate overview, financial summary, and SWOT analysis.

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Abstract, Snapshot, Market Analysis & Market Definition: Direct-to-Consumer Genetic Testing MarketIndustry / Sector Trends

Direct-to-Consumer Genetic Testing Market size was valued at USD 831.5 million in 2018 and is expected to witness 15.2% CAGR from 2019 to 2025.

U.S. DTC Genetic Testing Market Size, By Test Type, 2018 & 2025 (USD Million)

Rising prevalence of genetic diseases such as cystic fibrosis and Alzheimers globally is one of the major factors fostering direct-to-consumer genetic testing market growth. According to Global Genes, over 300 million people globally suffer from rare diseases. Recently developed DTC genetic tests allows consumer to identify probability of acquiring a specific genetic disease. Therefore, increasing adoption of DTC genetic testing for early disease detection and identification of genetic diseases will boost the industry growth over forecast timeline.

Increasing demand for personalized medications to treat genetic diseases will positively impact industry growth in forthcoming years. Individuals genome must be tested to develop personalized medicines. This increases the demand for DTC genetic kits since, it provides detailed information about individuals genetic predisposition. As detailed information regarding genetic makeup of individuals is easily available with the use of DTC genetic kits, researchers can easily design and develop personalized medicine that would help in faster patient recovery. Aforementioned factor is expected to drive the industry growth. However, high cost of DTC genetic testing kits may hamper industry growth to some extent during the forecast period.

Market Segmentation, Outlook & Regional Insights: Direct-to-Consumer Genetic Testing Market

Direct-to-Consumer Genetic Testing Market, By Test Type

Predictive testing segment will experience around 17% growth throughout the analysis period. Considerable segmental growth can be associated with rising prevalence of genetic diseases. Recently developed DTC genetic tests help to identify mutations that increase the chances of acquiring specific disease accurately. Surging awareness regarding benefits of such presymptomatic testing has reduced the mortality rates by enabling effective management of disease. Above mentioned factors have stimulated the segmental growth that is predicted to continue over the forecast timeframe.

Ancestry and relationship testing segment accounted for over 43% revenue share in 2018. Increasing awareness regarding ethnicity tests amongst the American and European population has increased the demand for DTC genetic tests. Accuracy and efficiency possessed by these tests has fostered segmental growth. Moreover, ancestry tests developed by companies such as Ancestry.com are user friendly. Availability of robust DTC ancestry tests providing meaningful clinical, genealogical and even forensic information will positively impact the segment growth.

Direct-to-Consumer Genetic Testing Market, By Technology

Targeted analysis segment was valued over USD 310 million in 2018. Targeted analysis is utilized for determining the defects in genes that are responsible for a particular disorder. Targeted genotyping can accurately measure an individuals gene pool that encodes important information regarding various diseases. Targeted analysis can be conducted at significant low cost compared to other available techniques that should augment its adoption rate over forecast timeframe.

Single nucleotide polymorphism segment will experience around 15% growth throughout the forecast period. Single nucleotide polymorphism chips specifically detect changes in single nucleotide that increases the efficiency of tests. For instance, SNP chips utilized for diagnosing hereditary cancers have detected 1300 mutations in BRCA2 genes. Various companies such as Ancestry.com and Color Genomics utilize SNP arrays that analyse gene sequences at a specific resolution and reveal detailed analysis about the defective genes that may in future cause certain disease. Increasing adoption of such advanced SNP chips in DTC testing kits will trigger the segmental growth.

Germany DTC Genetic Testing Market Size, By Technology, 2018 (USD Million)

Direct-to-Consumer Genetic Testing Market, By Region

North America direct-to-consumer genetic testing market accounted for around 39% regional share in 2018. Regional market growth can be attributed to increasing prevalence of genetic diseases. Rare genetic diseases such as thalassemia, hemophilia and anaemia require continuous and critical monitoring. According to CDC, every year more than 1,000 people are affected by thalassemia. Furthermore, American population has higher literacy rate and also, awareness regarding DTC tests is high amongst the American population that augments demand for DTC genetic tests.

Europe is estimated to experience around 15% growth over the coming years. European direct-to-consumer genetic testing market is highly regulated and for carrying out some of the genetic tests through DTC kits, customers are required to have physicians prescription. However, currently, European regulatory bodies are working on improving regulations set on DTC tests due to improved accuracy and efficiency possessed by them. Thus, improvement in regulatory scenario will positively impact regional market growth.

Latin America DTC Genetic Testing Market Size, By Country, 2025 (USD Million)

Key Players, Recent Developments & Sector Viewpoints: Direct-to-Consumer Genetic Testing Market

Few of the eminent industry players operating in direct-to-consumer genetic testing market are Ancestry, 23andMe, Color, Family Tree DNA, EasyDNA, Helix, Identigene, Full Genomes, Genesis HealthCare, Karmagenes, MyHeritage, MapMyGenome, Living DNA and Pathway Genomics. Chief industry players implement numerous initiatives such as mergers, acquisitions and new product launch to maintain their market position. Receiving approvals from regulatory bodies for new products will also foster companys revenue share. For instance, in October 2018, 23andme received first U.S. FDA approval for de novotechnology utilized in pharmacogenomic tests. This approval will enable company to launch innovative products, thereby fostering companys growth.

Direct-to-Consumer (DTC) Genetic Testing Industry Viewpoint

Direct-to-consumer genetic testing industry can be traced back to early 2000s. Earlier DTC tests were thought to be convenient as they would allow the patients to access their genetic information without involvement of physician. Although, DTC genetic testing kits had several benefits, in the initial days, they were stringently regulated by regulatory bodies. Regulatory scenario has always been stringent since the introduction of DTC genetic kits in European countries. Currently, there has been change in the regulatory scenario and European countries have started receiving approval for DTC genetic kits. Defects in the DTC kits have been reduced and people have started relying on these kits. DTC genetic testing market is sort of matured in North America due to numerous technological advancements and is still in developing phase in Asian countries. With further advancements in technology, DTC genetic tests industry will experience numerous growth opportunitie

Key Insights Covered: Exhaustive Direct-to-Consumer Genetic Testing Market1. Market size (sales, revenue and growth rate) of Direct-to-Consumer Genetic Testing industry.2. Global major manufacturers operating situation (sales, revenue, growth rate and gross margin) of Direct-to-Consumer Genetic Testing industry.3. SWOT analysis, New Project Investment Feasibility Analysis, Upstream raw materials and manufacturing equipment & Industry chain analysis of Direct-to-Consumer Genetic Testing industry.4. Market size (sales, revenue) forecast by regions and countries from 2019 to 2025 of Direct-to-Consumer Genetic Testing industry.

Research Methodology: Direct-to-Consumer Genetic Testing Market

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Direct-to-Consumer Genetic Testing Market: Trends, Applications, Industry Competitive Analysis, Growth,Forecast: 2019 to 2029 - The News Brok

We're so close to eradicating polio. Here's why we need $1.5 billion more to finish the job.

By Ryan Hyland and Erin Biba

When was polio last in Europe? If you guessed 2002, the year the region was certified polio-free, youre wrong.

The last time polio affected a child in Europe was 2015. Two Ukrainian children were diagnosed with paralytic polio, and that likely means that many more were infected and didnt show symptoms. At least one Western news outlet deemed the outbreak crazy but the reality is that no place on Earth is safe from polio until the disease is eradicated everywhere.

Ukraine had fully vaccinated only 50 percent of its children against polio, and low immunization rates are a recipe for an outbreak. In this case, a rare mutation in the weakened strain used in the oral polio vaccine was able to spread because so many children had not been vaccinated. To stop it from progressing, the country needed to administer 6 million vaccines through an emergency program.

Rotary was there at the beginning of the global effort to eradicate polio, says International PolioPlus Committee Chair Michael K. McGovern. It would be unfortunate if Rotary isnt there at the finish line. Weve done too much; weve made too much progress to walk away before we finish.

Finding poliovirus outside Afghanistan, Nigeria, and Pakistan, the only countries that have yet to eradicate it, is not unusual. In 2014, just before the World Cup brought travelers from all over the planet to Brazil, poliovirus was detected in the sewage system at So Paulos Viracopos International Airport. Using genetic testing, officials traced its origin to Equatorial Guinea. Brazils regular vaccination efforts kept the disease from showing up beyond the airport doors.

Those are frustrating examples for the thousands of people around the world working to eradicate polio. The fight has come a long way, but it is far from over. And while many involved in the effort say we may detect the final naturally occurring case of polio this year, getting to that point and ensuring that the disease remains gone will continue to require money, hard work, and the support of Rotarians around the world.

Here are the steps needed to ensure polio is truly gone forever:

One of the most important aspects of the fight to eradicate polio is detection. This requires continuous surveillance that is complicated and costly. Polio surveillance consists of two parts. First, doctors and community health workers monitor children for acute flaccid paralysis. The second part of the process involves local authorities collecting samples from sewage systems or in places that don't have adequate sanitation facilities, including rivers or bodies of water near a large group of residents.

Ninety percent of people infected with the virus show no symptoms, and those who do usually have mild symptoms such as fever, fatigue, and headaches. Only one in every 200 cases of the illness results in paralysis, which means that for every child who is paralyzed, several hundred are carrying the disease and may not show it.

And not every case of paralysis is caused by polio. Other viruses that can cause the polio-like symptoms known as acute flaccid paralysis include Japanese encephalitis, West Nile, and Zika. To determine if a patient has polio, health workers must collect two stool specimens 14 days apart and send them to a lab for testing.

To find the patients who don't present symptoms or don't make it to a clinic, Rotary and its partners in the Global Polio Eradication Initiative (GPEI) --- composed of the World Health Organization, the U.S. Centers for Disease Control and Prevention (CDC), UNICEF, and the Bill & Melinda Gates Foundation --- have set up environmental sampling sites in the areas that are most susceptible to the disease.

Fifteen to 20 countries are still at high risk despite having eradicated the illness. Because the poliovirus is most easily detected, and most easily contracted, through stool, researchers take samples from sewage systems and, in places that don't have sewer infrastructure, from rivers and open gutters.

GPEI has developed a network of 145 laboratories around the world that can identify the disease, and Rotary has played a leading role in supporting these facilities.

But regular environmental surveillance is "logistically not so easy to do and it's relatively expensive. It adds a considerable burden to the labs to process the sewage samples," says Stephen Cochi, senior adviser to the director, Global Immunization Division, at the CDC. "It costs real money to keep that network operational, and this lab network is the most highly sophisticated, state-of-the-art infectious-disease network in the world. Rotarians should be proud of that --- it's the No. 1 network, bar none."

As part of this system of labs, Rotary has helped fund small, sophisticated local laboratories to track genetic variations of the disease. All viruses mutate to confuse the human immune system, but the poliovirus is notorious for doing so at a rapid rate.

One of these labs allowed Brazilian authorities to trace the virus at So Paulo airport to Equatorial Guinea more than 6,400 kilometers (4,000 miles) away.

Vigilance is key to successful surveillance, says Michel Zaffran, director of polio eradication at WHO. "This is a hidden cost to the program that people don't realize is absolutely necessary to maintain," he said.

The GPEI is providing surveillance in about 72 countries, RI President John F. Germ said at Rotary's World Polio Day event on 24 October 2016. "It's an expensive fight," he said.

The appearance of polio in Ukraine in 2015 is a perfect example of why continued vaccination campaigns are essential --- and not only in Afghanistan, Nigeria, and Pakistan. Large-scale vaccinations are enormous undertakings that require money as well as thousands of volunteers on the ground. And in places where the vaccination programs have been successful, the challenge is now to locate and vaccinate that small percentage of children who have been missed.

The vaccine itself isn't the biggest expense in a vaccination. It's the distribution of the vaccine --- transportation and staffing, for example --- that costs so much. In January, a grant from Rotary covered the costs of an Afghanistan vaccination campaign that involved more than 57,000 vaccinators, 3,100 vehicles, and 3,400 social mobilizers. In Niger, funds covered the cost of using 17 boats, 1,150 carts, 1,071 vehicles, and 1,530 motorbikes.

Funds also went to initiatives in Somalia to cover the cost of more than 400 micro-planning workshops, 13,800 vaccinator and announcer trainings, and the use of more than 1,700 vehicles.

"I think sometimes people don't realize the scale of what these immunization campaigns are actually like," McGovern says. "Rotary and its partners have administered 15 billion doses since 2000. We've immunized 2.5 billion kids. Repeatedly reaching the kids to raise their immunization levels is very personnel-intensive."

A vaccination campaign is almost mind-bogglingly complex. Rotarians' contributions pay for planning by technical experts, large-scale communication efforts to make people aware of the benefits of vaccinations and the dates of the campaign, and support for volunteers to go door-to-door in large cities as well as in remote areas that may not appear on any map.

It sometimes includes overcoming local distrust of government or outsiders and negotiating complicated religious doctrine. And it means trying to understand the movements of nomadic populations or people pushed out of their homes because of unrest.

Regardless of how they live their lives, each of these children must be vaccinated.

Even if the last case of polio is identified this year, a huge amount of work will remain to ensure that it stays gone, which means vaccinating children for at least three more years.

And the vaccine itself will have to change.

Today's oral vaccines contain a weakened live version of the virus, which is much more effective at protecting communities from outbreaks and is less expensive to manufacture and distribute.

The live-virus vaccine, which has reduced polio by more than 99.9 percent, can, rarely, mutate back to a virulent form.

So once the virus has been certified eradicated, all of the live-virus vaccine around the world will be destroyed and replaced with an injectable vaccine that does not contain the live virus. And polio vaccinations will become a part of routine immunization programs around the world.

Once the final case of polio is recorded, it will take at least three years to ensure that the last case is, in fact, the final one. All of the eradication activities will continue to need funding and volunteers through at least 2020.

"We are so close," says John Sever, vice chair of Rotary's International PolioPlus Committee, who has been part of the eradication effort since the beginning. "We've got a 99.9 percent reduction in polio. But we're not there yet. Rotarians and others have to keep working. People will naturally say, 'Well, it seems to be basically gone so let's move on to other things,' but the fact is it isn't gone, and if we move on and don't complete the job, we set ourselves up for having the disease come right back."

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Why Rotary is investing in zero and beyond - World - ReliefWeb

She's the oldest snake documented in a zoo, and now the Saint Louis Zoo says this ball python just laid eggs, despite not being with a male companion in 15 years

ST. LOUIS A snake at the Saint Louis Zoo pulled off what seems like an impossible feat. She laid eggs this summer despite not being with a male companion in more than a decade.

On Tuesday, the zoo announced a ball python laid eggs back on July 23 at the Charles H. Hoessle Herpetarium.

This snake is more than 50 years old and is the oldest snake documented in a zoo, the Saint Louis Zoo reported. Plus, she hasnt been with a male in more than 15 years.

The zoo explained this isnt unheard of. Plus, theres not just one way it could have happened but actually two.

Keepers at the zoo explained ball pythons can reproduce sexually and asexually, which means the snake wouldnt need a partner to produce the eggs. On top of that, snakes are known to store sperm to fertilize eggs at a later time.

Now the question is, which of the two explanations is the reason for the eggs? the Saint Louis Zoo asked on social media. Zoo staff members plan to find out.

Without genetic testing, Zoo staff won't know if this ball python reproduced sexually or asexually, but they intend to find out. As the keepers continue to incubate the eggs, they will be sending off samples for genetic testing, the zoo explained.

The Saint Louis Zoo shared a video of the ball python featuring photos of her wrapped around her eggs and staff members carefully examining them.

See the article here:
50-year-old snake that hasn't been with a partner in 15 years just laid eggs - 11Alive.com WXIA

Global Newborn Genetic Testing Market 20202026: Industry Analysis, Growth Analysis, Price Analysis, And Trends

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SAN FRANCISCO, Sept. 3, 2020 /PRNewswire/ --Invitae (NYSE: NVTA), a leading medical genetics company, today announced enrollment has begun for a nationwide study to better understand the role of current genetic testing guidelines in ensuring prostate cancer patients receive testing to identify clinically relevant genetic variants that can inform prognosis and support access to targeted therapies. The study is supported by Invitae and is part of the company's ongoing work to increase access to genetic information for men with prostate cancer.

"Currently, germline testing guidelines for patients with prostate cancer have evolved from more than one set of NCCN guidelines and some may still find these guidelines difficult to implement in everyday practice," said Neal D. Shore, M.D., F.A.C.S. from the Carolina Urologic Research Center in Myrtle Beach, South Carolina, and the principal investigator of the study. "Guidelines were established when testing was both more expensive and less accessible and don't address newer therapeutic approvals and trial literature for expanding therapeutic options, missing many patients whose clinical care and treatment choices could benefit from genetic information. Our study is intended to provide a deeper understanding of how these issues impact the care of men with prostate cancer so that we might improve how genetic information can be assessed and utilized for their cancer care and potentially inform their family members."

The use and importance of genetic information in the diagnosis and treatment of prostate cancer has been growing, particularly as the development of targeted treatments continues to accelerate. Despite its utility, guidelines governing testing among prostate cancer patients remain restrictive, and genetic information is underutilized in prostate cancer care. The study will determine whether guidelines are adequate in identifying patients who may benefit from genetic testing.

"Simplifying and possibly expanding current testing guidelines would provide benefits for medical management of men with prostate cancer and offer opportunities for targeted therapies, including PARP inhibitors and qualification for clinical trials," said Robert Nussbaum, M.D., chief medical officer of Invitae. "In addition, the genes involved in prostate cancer include BRCA1 and 2, which as we all know also play an important role in breast and ovarian cancer, and MSH6 and other genes involved in hereditary colon cancer. Widespread testing among men with prostate cancer could have an important role in not only improving their care but also the health of their relatives."

The study will enroll men across the country who have been diagnosed with prostate cancer. Both men who meet and don't meet current testing guidelines will be included to gather data on whether genetic testing results change treatment and recommendations. In addition, the study will also gather data on the patient's experience with genetic testing.

A study presented recentlyby Invitae at the American College of Medical Genetics and Genomics (ACMG) underscored the frequency of actionable variants expanded testing can help uncover. The study of 2,252 men found an overall positive rate of 13% with no statistical differences in rates among stages of disease. Only half of patients with an actionable variant reported a family history suggestive of increased risk. Nearly three-quarters (71%) of positive patients were eligible for management guidelines and/or potentially eligible for approved precision therapies or clinical trials.

An estimated three million men are living with prostate cancer in the U.S., and just under 200,000 are newly diagnosed each year.

Contact clinicalstudies@invitae.com for more information about the study.

About InvitaeInvitae Corporation(NYSE: NVTA) is a leading medical genetics company whose mission is to bring comprehensive genetic information into mainstream medicine to improve healthcare for billions of people. Invitae's goal is to aggregate the world's genetic tests into a single service with higher quality, faster turnaround time, and lower prices. For more information, visit the company's website atinvitae.com.

Safe Harbor StatementThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the use and importance of genetic testing and information; and the benefits of simplifying and possibly expanding current testing guidelines for men with prostate cancer. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially, and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: the company's history of losses; the company's ability to compete; the company's failure to manage growth effectively; the company's need to scale its infrastructure in advance of demand for its tests and to increase demand for its tests; the company's ability to use rapidly changing genetic data to interpret test results accurately and consistently; security breaches, loss of data and other disruptions; laws and regulations applicable to the company's business; and the other risks set forth in the company's filings with the Securities and Exchange Commission, including the risks set forth in the company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2020. These forward-looking statements speak only as of the date hereof, and Invitae Corporation disclaims any obligation to update these forward-looking statements.

Contact:Laura D'Angelopr@invitae.com(628) 213-3283

Originally posted here:
Multi-site study to evaluate the role of testing guidelines in ensuring access to genetic information for men with prostate cancer - KPVI News 6

Boston startup Orig3n logged hundreds of false-positives as it processed COVID-19 tests for dozens of Massachusetts long-term care facilities. According to an Orig3n spokesman, the company continues to offer COVID-19 testing elsewhere in the U.S.

A Boston consumer genetics company that has batted away former employees accusations of shoddy practices since at least 2019 is now under investigation by the state Department of Public Health for logging hundreds of false positive coronavirus test results.

The company, Orig3n, has halted COVID-19 testing in the state. A company spokesman said the false positives were due to "human error" in processing the tests.

In August, after learning about the Massachusetts investigation, North Carolina issued a stop order for its coronavirus testing contract with Orig3n.

The consumer genetics startup, which claims it can tell customers what kind of foods they should eat and whether theyre predisposed to intelligence based on their DNA, has secured some of the biggest coronavirus testing contracts in the country.

According to an Orig3n spokesman, the company continues to offer COVID-19 testing elsewhere in the U.S.

So far, the Massachusetts DPH has found Orig3n sent out more than 300 COVID-19 tests wrongly classified as positive in Massachusetts, a number that could increase as DPH staff continue investigating. Orig3n claims the company isnt aware of any additional false positives. According to a Harvard epidemiologist and lab director, false negatives are far more difficult to discover, because most tests come back as negative.

Ted Owens, CEO at North Hills Pines Edge skilled nursing facility in Needham, one of roughly 60 long-term care facilities that used Orig3n test services, said in an Aug. 11 bulletin to residents and staff that Orig3n returned a total of 19 false positives to the nursing home.

The numbers didnt seem credible to Owens, but Pines Edge began immediately to take actions based on the working assumption that we needed to treat these results as correct.

It turned out that several other skilled nursing facilities also showed an unusual spike in positive cases last week, and oddly enough, all these facilities had used the same testing vendor, Owens continued. This caught the attention of the epidemiologists at Mass DPH, who intervened and instructed the vendor to re-test the samples."

Upon retesting, all of the positive tests were found to be negative.

The spike in cases which turned out to be false positives caused panic in Needham. They came as the school district made plans to return to in-person learning, and a public health nurse for the town was asked to appear before the Select Board.

Needham public health nurse Tiffany Zike told the board on Aug. 18 that a number of coronavirus cases reported in July were considered false cases that were revoked due to the lab having an issue.

$25,000 wire transfer

In early May, nursing homes throughout Massachusetts were looking for a miracle.

The DPH had ordered long-term care facilities coping with severe coronavirus outbreaks to test 90% of residents and staff for COVID-19 by May 25 in order to qualify for a portion of $130 million in relief funding offered by the state.

Many nursing homes struggled to meet the deadline because of a shortage of COVID-19 tests. The National Guard was testing nursing home residents and staff on behalf of the state, but demand was high.

When Ron Doty got a memo from the Massachusetts Senior Care Association on May 6 offering Orig3n as a turnkey mobile testing option, he immediately reached out to the company.

Doty, administrator at Marlborough Hills Rehabilitation & Health Care Center in Marlborough, wired $25,000 to Orig3n. The next day, he received 250 COVID-19 test kits from the company.

Two months later, Orig3n was asked to suspend COVID-19 testing in Massachusetts, which it did on Aug. 8. Staff at the DPH noticed the lab was reporting an unusually high rate of positive tests, prompting the agency to investigate, according to a DPH spokesperson.

The state DPH declined to identify which nursing homes used Orig3ns testing services, citing the ongoing investigation.

Tony Plohoros, Orig3ns spokesman, said the lab is now working with state health officials to correct problems in its Boston lab, which has ceased processing coronavirus samples but continues to process consumer genetic profiles.

While it remains unclear if the federal government has taken action to halt use of Orig3ns COVID-19 testing services in other parts of the country, as North Carolina did, concerns about Orig3n hadnt yet reached a health care supply company in Ohio as of this week. That company, Mason, Ohio-based Link-age Solutions, is still working with Orig3n to provide coronavirus tests to long-term care facilities nationwide.

Patrick Schwartz, a spokesman for Link-age Solutions, said Thursday that the company was unaware Orig3n was asked to cease coronavirus testing in Massachusetts.

One of the highest accuracy ratings in the market

Orig3n received an emergency authorization to conduct COVID-19 testing from the Food and Drug Administration in April.

The same month, the company received a federal Paycheck Protection Program loan valued between $350,000 and $1 million from Silicon Valley Bank, according to U.S. Treasury data.

Since getting the FDA approval, Orig3n has provided testing services to The New England Power Generators Association, Bostons homeless population, a boarding school in Virginia and other public and private entities.

In late June, Link-age Solutions, which helps long-term care facilities nationwide obtain supplies ranging from pharmaceuticals to office supplies, issued a press release touting Orig3ns breakthrough testing method as having one of the highest accuracy ratings in the market.

In partnering with Orig3n, Link-age could offer in-demand coronavirus tests to its members at a reduced cost, according to the press release. Results would be returned less than 36 hours after specimens arrived at the lab, the release said.

The lab boasts output capabilities of 6,000 and up to 12,000 tests per day, and will offer billing to Medicare where appropriate, the press release stated. Reporters questions to the Centers for Medicare & Medicaid Services have gone unanswered.

Schwartz, the Link-age spokeman, said Thursday his company continues to offer COVID-19 testing services performed by Orig3n, and that feedback about Orig3ns tests from its customers has been positive.

Company flagged in the past

Orig3n lists its office location as the third floor of 27 Drydock Ave. in the heart of Bostons Seaport neighborhood. Until August, thats where the company processed its coronavirus tests.

Before it got into the coronavirus business, Orig3n billed itself as a consumer genetics pioneer, carving a path toward a future of wellness and health through the use of diagnostics, genetics and biotechnology.

The company, founded in 2014, offers tests ranging in cost from $29 to $298 that are supposed to help people learn what kinds of food, exercise and beauty products would work best for their genetic profiles, and even whether they are genetically predisposed to so-called superhero traits including intelligence and strength, according to Bloomberg Businessweek.

A former Orig3n employee who spoke to Gannett New England reporters on the condition of anonymity because of a nondisclosure agreement with the company said the number one complaint received by customer service was genetic profile tests not being returned to customers. The employee, who left the company pre-pandemic, didnt think the company could handle both genetic profile testing and coronavirus testing.

Unless things drastically changed since I have left, not even testing, just bandwidth-wise, they were already kind of drowning when I left, the employee said.

Despite its startup status, Orig3n quickly gained prominence partly through securing big-name partnerships, including one with the NFLs Baltimore Ravens.

In September 2017, the Ravens linked up with Orig3n for an event called DNA Day. Roughly 70,000 Ravens fans were set to pour into the teams stadium, where they could have picked up a free genetic testing kit.

The event never happened. The Ravens postponed it days before federal health officials told The Baltimore Sun they were working to determine whether any of the testing being offered by Orig3n is subject to the requirements of the Clinical Laboratory Improvement Amendments of 1988.

The federal regulatory standards apply to labs testing human samples in the United States, and are intended to ensure accuracy, effectiveness and reliability.

About a year after DNA Day was scrapped, 17 former Orig3n employees criticized the company in Bloomberg Businessweek, alleging it habitually cut corners, tampered with or fabricated results, and failed to meet basic scientific standards.

Marketing, not science, the employees said, was the companys priority.

Press releases put out by Orig3n throughout the pandemic show the company was eager to publicize contracts with respected institutions, both public and private.

On May 12, the company announced what it called a comprehensive solution to enable COVID-19 testing for Massachusetts nursing home residents.

In the press release, the company said it sought to become the partner of choice for coordinating and providing COVID-19 testing for defined populations beyond long-term care residents and employees, including private employers, schools, government agencies, and cities and states.

The nursing home program is one of many applications for Orig3ns fully-integrated solution, the press release said.

What went wrong?

Doty, the Marlborough nursing home administrator, would not have known about Orig3n if not for the May 6 memo from Massachusetts Senior Care Association, an organization many nursing homes relied on during the viruss spring surge in the state to interpret complex and shifting guidance from the DPH.

Massachusetts Senior Care Association President Tara Gregorio said in a statement that her organization essentially serves as a messenger for its members, and that it relies on governmental agencies to vet labs like Orig3n.

"Throughout the pandemic, MSCA has passed along lists of government approved COVID-19 PCR testing labs options available to our members, Gregorio wrote. We must rely, as all providers do, on the licensing process to ensure legitimacy and accuracy of these labs."

The FDA, which gave Orig3n emergency authorization to conduct coronavirus testing last spring, has not yet responded to Gannett New England reporters seeking comment.

According to a Massachusetts DPH spokesman, Orig3n told the agency after it was contacted by DPH that errors in testing occurred because of a broken vial or contaminated plate during final processing, an explanation DPH investigators are now trying to confirm.

In an email to Gannett New England reporters on Friday, Plohoros, Orig3ns spokesman, said human error at the beginning of the laboratory testing process caused a pre-extraction reagent that was used in the affected batch tests to become contaminated.

In an Aug. 18 press conference, Massachusetts Secretary of Health and Human Services Marylou Sudders said erroneous results from Orig3n affected the number of COVID-19 cases reported in Fall River and Taunton.

The positive test rates for that three-day period for that one lab just seemed high, and so (we) went back, and the lab stopped processing, they're still not processing any tests, Sudders said, adding that DPH staff was analyzing tests processed prior to the discovery to make sure the issue was, as Orig3n told the DPH, a one-time problem rather than a more structural issue.

Dr. Michael Mina is an assistant professor of epidemiology at Harvard T. H. Chan School of Public Health who has experience running laboratories that perform PCR testing.

Mina says a lab that processes 6,000 to 12,000 PCR coronavirus tests a day as Orig3n has said it does would need to be run with what he called extreme quality control measures.

It requires an amazing amount of concentration and care to really ensure you're not getting contamination or any number of other problems that can happen, he said. If this was an easy (test), I would have said, sure, any lab can do it but this particular (test) ... it really is a finicky test. You have to be extremely careful about how you're doing it, and that means you need a lot of quality controls. You need to be a really diligent lab.

Mina, who stressed he has no knowledge of Orig3n other than circulating allegations that the company had previously been investigated, said when a mistake like the kind Orig3n described occurs, staff should immediately stop processing, sterilize the area and alert any affected patients and health departments.

The fact that the Massachusetts DPH noticed the problem and not Orig3n is a problem, Mina said.

That shows in general that the quality control wasn't being maintained, he said, adding that performing intense quality control checks multiple times daily is a core tenet of running any lab, especially a high-complexity clinical lab. And if we're giving them the benefit of the doubt, they didn't know that there was a problem because otherwise it's just nefarious.

Mina said that a professionally run lab would likely have caught the mistake, and alerted the state DPH immediately.

Part of the reason for that is simply a motive to care for the patient, who will likely make important decisions about their own behavior based on the test result they receive, which in turn affect other people.

At Brigham, for example, where I was one of the medical directors, of course people feel embarrassed (about making a mistake), but there's this strong culture where people recognize that their embarrassment is not worth a patient's hardship, Mina said. That's one thing that really, I think, lacks a little bit when we move into industry laboratories running clinical tests. That same spirit of honesty ... might not exist everywhere.

While mistakes at labs are common, Mina said, they're also commonly fixed and they don't usually require an investigation.

Mina said that the U.S. did need to increase its capacity to process coronavirus tests this spring, but labs, especially ones new to the medical diagnostics space, as Orig3n is, need to be monitored closely.

It's just important to keep all these things in check, Mina said. The frenzy to do coronavirus testing has been so extreme. I don't think labs should be immediately shut down for mistakes, but we have to remain vigilant to ensure that all the testing that is being done is up to the highest standards.

Trevor Ballantyne and Jeannette Hinkle are reporters for Gannett New England.

Originally posted here:
The sudden spike in Mass. COVID-19 cases was jarring. Now, the company that did the tests is under investigation. - The Gardner News

John Wagner was 38 when he was diagnosed with late stage colon cancer, a story that resembles the late Chadwick Boseman.

LOUISVILLE, Ky. The sudden death of actor Chadwick Boseman has everyone talking about colon cancer that ended his life at 43.

It's a reminder of the cancer risk that's rising among younger generations, even more so for Black men in this country.

This week, the American Cancer Society said it saw an 8,000% increase in traffic to its colorectal cancer symptoms page since Boseman's passing. It's a combination of colon and rectal cancers (CRC), often grouped together because they have many features in common.

"When I first figured out I had colon cancer, I was 38 years old," John Wagner said.

Wagner wasn't scheduled for a colonoscopy for another 6 years. He had no family history and considered himself a healthy guy, when he started feeling weak, having severe constipation and blood in his stool.

"He didn't smoke, or drink or do anything, and here you get this diagnosis, and you're like, wait. 'How did I get here?'" his fianc, Sharise Durrett said.

Multiple doctors sent him home without screening for cancer. At least one brushed it off as diverticulitis.

"I kept asking. They said, I was too young," said Wagner. "If it wasn't for that ER nurse, no telling what might have happened."

Durrett encouraged him to go to the ER where he received a colonoscopy. That's when they found the cancer. It had already spread to his liver.

Wagner's case is one of 145,000 new colorectal cases diagnosed in the U.S. every year. While the majority are in adults older than 50, it's the younger generation that's seen a rapid increase of cases over the last decade, and if you're Black, your risk is 20% higher than most, which increases even more for men, who are already 30% higher than women in the risk category.

The reasons are not clear, but doctors have general ideas.

"We know there are risk factors, like diet, exercise, smoking, obesity, and things like that, that play into this, but I think access plays a big part of that," Dr. Michael Driscoll, a medical oncologist, with Norton Cancer Institute said.

Insurance for most people, will only cover the costs of cancer screenings, if they're at or above the recommended age. For colon cancer, it's 45, unless you have a family history. In that case, screening should start earlier at age 40 or 10 years sooner than the age their relative was diagnosed.

"Any person with CRC under the age of 50 should also undergo genetic testing to make sure they are not dealing with a hereditary cause, such as Lynch Syndrome, which affects 1 in 279 of all races and both sexes," Dr. Whitney Jones, with the Colon Cancer Prevention Project said. "It's the most common cause of genetic colon cancer in America. Family history is critical."

"The colonoscopy is the gold standard," Dr. Driscoll said.

The problem: it's developing well before our golden years, and often times, has already spread before we start experiencing symptoms.

If this is happening to you, demand a test and nothing less.

"Colon cancer is 90 percent preventable," Dr. Driscoll said.

Still, close to 53,000 colon cancer patients will die this year. "Black Panther" star Chadwick Boseman was one of them.

"We were actually watching television together when it came on as breaking news," said Durrett. "It felt as if Chadwick was a member of our family because at that moment, John's life and Chadwick's life were parallel. There were so many similarities, it was scary."

She said the two sat in silence for the next 10 minutes. They know the numbers aren't in their favor.

People with Stage 4 Colon Cancer have less than a 10% survival rate.

"Ultimately, God has the final say," Durrett said.

But that's not stopping Wagner from trying.

"My goals are set high. I'm going to beat this. I can't let it get me down. There's no giving up," Wagner said.

In Kentucky, about 70% of people above the age of 50 get screened. It's about 68% in Indiana. Dr. Driscoll says that's not good enough.

Kentucky leads the nation in both under age 50 CRC incidence and overall CRC incidence. "But our screening rates are improving more rapidly than any state in the nation," Dr. Jones said. "Also, due to the long work of many organizations, screening rates and outcomes are equal for both blacks and whites. Our greatest disparity in outcomes is actually in Appalachia."

Kentucky state laws - by statute - in CRC screening coverage, follow the American Cancer Society guidelines, stating people with no family history of polyps or CRC can be covered for screenings at age 45. Medicaid's included.

Dr. Jones says, "on-time screening at age 45 with a colonoscopy or home stool tests (FIT or stool DNA, Cologuard) will save many lives if we can get the word out. Choice gets more people engaged in screening due to shared decision making."

Contact reporter Brooke Hasch atbhasch@whas11.com. Follow her onTwitter (@WHAS11Hasch)andFacebook.

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Link:
'I kept asking, they said I was too young' | The risks of colon cancer - WATN - Local 24

However, the chances of taking home a baby are still largely dependent on a woman's age and the IVF clinics treating them. Individual clinic success rates range between 7 per cent and 31 per cent of cycles.

There were 14,355 babies born via IVF from 76,341 IVF cycles in 2018 according to the report collated by the National Perinatal Epidemiology and Statistics Unit at UNSW and funded by the FSA. This is up from 13,752 IVF babies in 2017.

The report covers all IVF cycles undertaken in Australian and New Zealand clinics in 2018 and the resulting babies born in 2018 and 2019.

IVF clinics are increasingly doing "freeze-all" cycles, in which all the eggs or embryos collected in a cycle are cryopreserved rather than transferring a fresh embryo.

The proportion of freeze-all cycles doubled in five years from 13 per cent to 26.7 per cent in 2018.

Professor Rombauts said the main driver of the freeze-all trend was the rise in pre-implantation genetic testing, in which embryos are screened for chromosomal abnormalities in the hope of selecting only the healthy embryos to transfer.

"For women over 35 in particular genetic screening can be beneficial, when there is a higher risk of abnormalities," he said.

"Genetic testing can reduce the time, money, energy and trauma it takes to have a healthy live birth because you're potentially not transferring embryos that are doomed to fail."

However, growing evidence suggests there could be a small risk that pre-implantation genetic testing could lead to viable embryos being discarded by incorrectly flagging them as abnormal.

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"For women under 35 I would certainly not recommend it it's an extra manipulation on the embryos and an extra cost," Professor Rombauts said. "But for older women, it can be an important test and I would raise it as an option because there is potential benefit."

Laura Smith, 34, from Forest Lodge is the proud mother of 4-month-old Hunter after undergoing IVF at Genea. "For me, he's perfection and everything I ever wanted," she said.

Ms Smith, who has polycystic ovarian syndrome, and her husband Ben spent a couple of years trying to conceive naturally then about a year trying other fertility treatment before turning to IVF.

Her eggs were harvested in one cycle and the embryo that became Hunter implanted a month later, while the others are frozen for future use. The couple intend to try for a second child fairly quickly.

It's an absolutely fantastic thing that we've been given this technology ... who knows if I would have had a baby by now if I didn't have IVF?

"I was very lucky I fell pregnant the very first round of IVF and I had no complications or issues," Ms Smith said. "It's an absolutely fantastic thing that we've been given this technology and the ability to be able to have babies in this way who knows if I would have had a baby by now if I didn't have IVF?"

She opted to use a frozen embryo because of medical advice it would improve her odds to harvest and implant on different cycles and to enable genetic testing.

IVF clinics are reporting dramatic differences in their success rates. One clinic had a live birth rate of roughly 7 per cent of initiated cycles, compared to 31.5 per cent at the clinic with the highest success rate.

The clinics were not identified in the report and should be interpreted with caution. For instance, some clinics may specialise in second referrals for complex patients, older women, or younger, uncomplicated cases.

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A new federal-government-funded website will soon give would-be parents access to individual clinic success rates and their own chances of taking home a baby after undergoing IVF based on their individual characteristics.

The 'My IVF Success' website is expected to be ready to launch before the end of the year in response to growing calls for greater transparency in the sector.

Age is still a powerful determiner of IVF success, with younger women having better chances. For women under 30 years, live birth rate per fresh embryo transfer was 40.4 per cent compared to 9.5 per cent for women aged 40 to 44.

For frozen embryo transfers, the live birth rate was 34.9 per cent in women under 30, and 20.1 per cent for women aged 40 to 44.

Professor Georgina Chambers, the report's lead author and Director of UNSW's National Perinatal Epidemiology and Statistics Unit said the higher live birth rate for older women via frozen cycles was mostly because the embryo was created in an earlier fresh cycle when she was younger.

"It's also because we're increasingly using pre-implantation genetic testing to select the healthy embryos for transfer rather than putting back embryos that aren't viable," Professor Chambers said.

In 2018, the average age of women using their own eggs was 35.8 years about five years older than the median age at which women, in general, gave birth in Australia (30.7 years).

The average age of women using donor eggs or embryos was 40 and the average age of male partners of women undergoing IVF was 38.1 years old.

The proportion of twins and triplets born via IVF treatment is now a record low 3.2 per cent in Australia and New Zealand thanks to the decrease in multiple embryo transfers in the one cycle.

with Caitlin Fitzsimmons

Kate Aubusson is Health Editor of The Sydney Morning Herald.

More here:
'Quite amazing': One in 10 babies born to women over 35 now conceived via IVF - Sydney Morning Herald