Archive for June, 2021

The GlobalGenetic TestingMarket Research Report 2021-2028 is a valuable source of insightful data for business strategists. It provides the industry overview with growth analysis and historical & futuristic cost, revenue, demand and supply data. The research analysts provide an elaborate description of the value chain and its distributor analysis. This Market study provides comprehensive data which enhances the understanding, scope and application of this report. The Global Genetic Testing Market Report enfolds a comprehensive analysis and assessment of the global Genetic Testing market. The report mainly intends to help market players and clients to understand the market in terms of structure, scope, profitability, attractiveness, and growth possibilities. The report also highlights a detailed review of market segmentation, potentials, emerging trends, and volatilities in the global Genetic Testing market. Global Genetic Testing Market Report 2021 report records detailed estimation to improve complete information of the global Genetic Testing market today and its industrial outlook based completely on the current and purpose marketplace.

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The report contains in-depth information on all the major aspects of the global Genetic Testing market. This report contains key information such as facts and figures, market research, market analysis, SWOT analysis, risk analysis, competitive landscape, regional analysis and growth estimates. The report also contains qualitative and quantitative research which gives you a detailed overview of the global Genetic Testing market. The report is perfect as you will get crucial information on the recent market scenario, based on which you can make business decisions, risk assessments and investments in the Genetic Testing industry. The report provides the market share, market size (volume and value), rate of growth by types, applications, and combines both qualitative and quantitative methods to make micro and macro forecasts in several regions or countries.The Genetic Testing market including the ebb and flow patterns, openings, drivers, restrictions, statistics is collected through authentic sources, and improving Plans for the Industry.

Scope of Genetic Testing Market:The global Genetic Testing market is valued at XX million US$ in 2019 and will reach XX million US$ by the end of 2028, growing at a CAGR XX% of during 2021-2028. The objectives of this study are to define, segment, and project the size of the Genetic Testing market based on company, product type, application and key regions.

Moreover, the report elucidates a thorough assessment based on organizational, manufacturing, and financial details of leading Genetic Testing companies. Their remunerative market strategies such as product launches, brand developments, mergers, acquisitions, partnerships, product innovation, technology adoption, product research, and development are also analyzed in this report. The report further evaluates their Genetic Testing sales volume, production volume, value chain, raw material sourcing strategies, revenue, annual growth rates, and CAGR. Their organizational structure, corporate alliances, distribution networks, and global presence are also studied in the report. From the market shares in the industry, to their growth and expansion plans, investments, developments and all other key information has been compiled in this report to help you get a complete overview on the performance of the top players in the Genetic Testing industry. The report includes the regional forecasts, competitive landscape analysis, risk analysis and discussion of industry trends, market size, market shares, growth potential estimates and future business plans of the key players.

The research report has incorporated the analysis of different factors that augment the markets growth. It constitutes trends, restraints, and drivers that transform the market in either a positive or negative manner. This section also provides the scope of different segments and applications that can potentially influence the market in the future. The report entails detailed profiling of each company, and information on capacity, production, price, revenue, cost, gross, gross margin, sales volume, sales revenue, consumption, growth rate, import, export, supply, future strategies, and the technological developments, are also included within the scope of the report. In the end, the Genetic Testing Market Report delivers a conclusion which includes Breakdown and Data Triangulation, Consumer Needs/Customer Preference Change, Research Findings, Market Size Estimation, Data Source. These factors are expected to augment the overall business growth.

Competitive Landscape:This section of the report identifies various key manufacturers of the market. It helps the reader understand the strategies and collaborations that players are focusing on combat competition in the market. The comprehensive report provides a significant microscopic look at the market. The reader can identify the footprints of the manufacturers by knowing about the global revenue of manufacturers, the global price of manufacturers, and production by manufacturers during the forecast period of 2021 to 2028. Company profile section of players such asGeneDx, Invitae, Pathway Genomics, Counsyl Inc, Asper Biotech, GenePlanet, Courtagen Life Sciences, Gene By Gene, Natera Inc, Regulatory, GeneTests, United Gene, HI Gene, Berry Genomics, 23andMe Inc, 360Jiyin, Novogene, CapitalBio, Agen, Biomedlab, Biomarker, Annoroad, Aiyin Gene, Aijiyin, Repconex, Find Bio-Tech, SinoGenoMax, Gene Kang, Geeppine, BGI.

Geographical data will help the reader understand the best performing regions. This report has added an examination and increment pace of the market in these districts covering North America (United States, Canada and Mexico) Europe (Germany, France, UK, Russia and Italy) Asia-Pacific (China, Japan, Korea, India and Southeast Asia) South America (Brazil, Argentina, Colombia etc.) Middle East and Africa (Saudi Arabia, UAE, Egypt, Nigeria and South Africa)

Global Genetic Testing Market by Type:Newborn Screening, Diagnostic Testing, Carrier Testing, Preimplantation Genetic Diagnosis, Prenatal Diagnosis, Predictive and Presymptomatic Testing, Pharmacogenomics

Global Genetic Testing market segments by Applications:Cardiology, Dermatology, Hematology, Hereditary Cancer, Immunology, Metabolic Disorders and Newborn Screening, Neurology, Ophthalmology, Pediatric Genetics, Others

The key points covered in this report are: This report offering the outline of the market, market size and share, and growth rate over the forecast period 2021-2028 The report covers the data of the top regions, product type, application, market value and size, industry verticals, and end-users of the market. It also states the up-to-date landscape, historical data, and future forecast of the market. To realize the supply and demand analytics, including supply and consumption ratio, mapping of the market has been carried out. Porters five forces analysis and SWOT analysis, including the cost structure analysis, has been carried out in this report. The report also offers a Six-year prediction examination on the basis of how the market is foreseen to grow.

The Global Genetic Testing report offers: Market share assessments for the regional and country level segments. Market share analysis of the top industry players. Strategic recommendations for the new entrants. Market forecasts for a minimum of 6 years of all the mentioned segments, sub segments and the regional markets. Market Trends (Drivers, Constraints, Opportunities, Threats, Challenges, Investment Opportunities, and recommendations). Strategic recommendations in key business segments based on the market estimations. Competitive landscaping mapping the key common trends. Company profiling with detailed strategies, financials, and recent developments. Supply chain trends mapping the latest technological advancements.

Why To Buy Report?1.It offers a comprehensive analysis of industry-based verticals.2.It offers 2021-2028-year forecast assessment on the basis of markets growth.3.It helps in understanding the key segments and sub-segments.4.It provides review from different stakeholders, vendors, and clients for the Genetic Testing Market.5.Track the competitive developments as well as research and developments in the global Genetic Testing Market.6.What are the key consequences of the five forces analysis of the Global Genetic Testing market

The report can help to know the market and strategize for business expansion accordingly. Within the strategy analysis, it gives insights from market positioning and marketing channel to potential growth strategies, providing in-depth analysis for brand fresh entrants or exists competitors within the Genetic Testing industry. Global Genetic Testing Market Report 2021 provides exclusive statistics, data, information, trends and competitive landscape details during this niche sector.

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Moreover, the report provides knowledge of the leading market players within the Genetic Testing market. The industry changing factors for the market segments are explored in this report. This analysis report covers the growth factors of the worldwide market based on end-users. In 2020, the market was growing at a mild rate and with the rising adoption of strategies by key players, the market is predicted to rise over the projected horizon. The report also tracks the most recent market dynamics, like driving factors, restraining factors, and industry news like mergers, acquisitions, and investments.

Customization of the Report:1)All segmentation provided above in this report is represented at country level.2)All products covered in the market, product volume and average selling prices will be included as customizable options which may acquire no or minimal additional cost (depends on customization).

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Global Genetic Testing Market Trends, Forecast and Competitive Analysis (2021-2028) | GeneDx,Invitae,Pathway Genomics The Manomet Current - The...

In the second part of our whats exciting the experts series, Medical News Today spoke with another group of cancer experts. We asked them what recent advances have given them the most hope. Here, we provide a sneak peek at the fascinating forefront of cancer research in 2021.

Cancer is not a single disease but a collection of diseases. It is complex and does not readily give up its secrets. Despite the challenges cancer poses, scientists and clinicians continue to hone the way in which they diagnose and treat it.

Modern medicine means that diagnosis rates for many cancers are up, as are survival rates. However, with an estimated 19.3 million new cases of cancer worldwide in 2020, there is still much work to be done.

MNT recently contacted a number of medical experts and researchers and asked them to speak about the aspects of cancer research that they find most exciting. Their answers are fascinating and demonstrate the incredible variety of approaches that scientists are using to understand and combat cancer.

We will start todays journey into cutting edge oncology with a surprising guest: magnetically responsive bacteria.

Due to the difficulty of targeting systemically delivered therapeutics for cancer, interest has grown in exploiting biological agents to enhance tumor accumulation, explained Prof. Simone Schrle-Finke, Ph.D., from ETH Zurich in Switzerland.

In other words, getting cancer drugs to the right place is not as straightforward as one might hope. Prof. Schrle-Finke is among the researchers who are now enlisting the help of specialized bacteria.

She told MNT how scientists have known for a century that certain bacteria can colonize tumors and trigger regression. She explained that today, thanks to modern genetic engineering techniques, attenuated bacteria are available that can have a therapeutic effect exactly where this is necessary.

These therapeutic effects include secretion of toxins, competition for nutrients, and modulation of immune responses.

However, despite the promise of bacterial cancer therapy, there are still challenges to meet. Delivering the doses to the right place and getting them into the tumor remain foremost among challenges hampering clinical translation only about 1% of a systemically injected dose reaches the tumor, explained Prof. Schrle-Finke.

To address these challenges, her team at ETH Zurich is using magnetically responsive bacteria.

These so-called magnetotactic bacteria naturally orient themselves like compass needles to Earths magnetic field.

Although this ability evolved for navigation, scientists are keen to find out whether magnetic steering or pulling could allow them to repurpose it for cancer delivery.

In a recent study, Prof. Schrle-Finke and her colleagues used rotating magnetic fields to override the bacterias natural propulsion. As the authors of the study explain, they used swarms of magnetotactic bacteria to create a directable living ferrofluid.

These magnetotactic bacteria have a high demand for iron, so once they reach the tumor, as Prof. Schrle-Finke told MNT, they can metabolically influence cancer cells through starvation from this vital nutrient. We have shown in in vitro models that an increasing number of bacteria induce an upregulation of iron-scavenging receptors and death in cancer cells.

By uniting engineering principles and synthetic biology, we aim to provide a new framework for bacterial cancer therapy that addresses a major remaining hurdle by improving the efficiency of bacterial delivery using safe and scalable magnetic stimuli to these promising living therapeutic platforms.

Prof. Simone Schrle-Finke, Ph.D.

Personalized medicine is transforming the landscape of medicine and how healthcare providers can offer and plan personalized care for each of their patients, believes Dr. Santosh Kesari, Ph.D., director of neuro-oncology at Providence Saint Johns Health Center in Santa Monica, CA.

Dr. Kesari is also chair of the Department of Translational Neurosciences at Saint Johns Cancer Institute and regional medical director for the Research Clinical Institute of Providence Southern California.

Describing personalized medicine, Dr. Kesari said, It is an approach for disease prevention and treatment that takes into account biological, genetic, behavioral, environmental, and social risk factors that are unique to every individual.

He continued, Personalized medicine is rooted in early detection and prevention; integrating data from genomics and other advanced technologies; digital health monitoring; and incorporating the latest medical innovations for optimizing outcomes.

This is becoming very apparent in oncology, where genetic testing for tumor mutations and predispositions is increasingly being utilized and showing more value in using targeted drugs more wisely and improving outcomes.

Dr. Santosh Kesari, Ph.D.

Some personalized cancer approaches are already in use, such as EGFR, HER2, and NTRK inhibitors and the super personalized CAR-T cells.

According to Dr. Kesari, the future of personalization is bright, and progress has only accelerated in the past 5 years.

Continuing with the personalization theme, Dr. Robert Dallmann from Warwick Medical School at Warwick University in the United Kingdom talked with us about chronotherapy:

Propelled by the 2017 Nobel Prize in Medicine or Physiology [going] to three circadian biologists for uncovering the molecular mechanism of circadian biological clocks, cancer chronotherapy is gaining critical momentum to enter mainstream oncology especially in the context of personalized medicine.

Dr. Dallmann explained that many key physiological processes in the cells of our body are modulated in a daily fashion by the circadian clock. These cellular clocks are disrupted in some tumors but not in others.

Interestingly, a functional clock in the tumor predicts the survival time of patients, which has been shown for brain as well as breast tumors.

Therefore, he explained, if scientists could determine the clock status in solid tumors, it would allow doctors to more easily determine whether a patient is at high or low risk. It might also help guide therapy.

There is great potential in optimizing treatment plans with existing drugs by taking into account the interaction with the circadian system of the patient, continued Dr. Dallmann.

More recently, the circadian clock mechanism itself has been proposed as a novel treatment target in glioblastoma. The authors of the glioblastoma study concluded that pharmacologic targeting of circadian networks specifically disrupted cancer stem cell growth and self-renewal.

However, whether this might be generalized to many solid tumors or even other chronic diseases remains to be elucidated, said Dr. Dallmann.

In summary, he told MNT, circadian clocks have long been recognized to modulate chronic disease on many levels. The increased mechanistic understanding has the potential to improve diagnosis and existing treatments of cancer, as well as develop a new class of clock-targeting treatments.

Dr. Chung-Han Lee is a medical oncologist at Memorial Sloan Kettering Cancer Center in New York. He is also a member of the Kidney Cancer Associations Medical Steering Committee. He talked us through recent advances in the treatment of kidney cancer.

The development and subsequent regulatory approval of combination immunotherapy for patients with metastatic kidney cancer have led to transformative change in the lives of many patients and are the hallmark of how greater scientific understanding has impacted cancer care, Dr. Lee told MNT.

Prior to 2005, treatment for metastatic kidney cancer was very limited, with most patients passing away in less than 1 year despite undergoing treatment. According to Dr. Lee, the development of antiangiogenic drugs that inhibit the growth of new blood vessels was among the first breakthroughs to improve the outcomes for patients.

However, even with antiangiogenic drugs, most patients ultimately developed resistance to treatment, and 18 months was considered a long-term response. Next came immunotherapies.

Prior to the development of antiangiogenic medications, it was known that kidney cancer could be treated by activating the immune system to better recognize the disease. However, the tools to activate the immune system were often very nonspecific. Therefore, responses to these early immunotherapies were rare, and the side effects related to treatment were not only burdensome but also could be life threatening.

With recent advances in immunotherapy, we have demonstrated that more targeted immunotherapies that activate specific immune checkpoints are not only possible but can have substantially increased activity against disease.

Two emerging treatment approaches have now become the new standard of care for kidney cancer: dual immunotherapies (such as ipilimumab/nivolumab) or combinations of antiangiogenic targeted therapies with immunotherapies (such as axitinib/pembrolizumab).

In patients treated with ipilimumab and nivolumab, over 50% remain alive at 4 years, and with some [combined antiangiogenic and immunotherapy approaches], nearly 50% of patients remain on their initial therapy at 2 years.

Despite these advances, Dr. Lee is far from complacent, telling us that there remains considerable work to be done. [] Unfortunately, in 2021, for most patients, kidney cancer remains fatal. Even for those who have outstanding responses to treatment, most still require ongoing systemic therapy.

With the rapid improvements in treatments, the development of correlative biomarkers, and the improved biologic understanding of the disease, we have only started to entertain the possibility of curative, time-limited therapy.

Building on the sacrifices of patients and caregivers and the hard work of clinicians, research staff, and scientists, a cure may, one day, be a reality for our patients, he concluded.

Our study from late 2020 has shown that the antidepressant sertraline helps to inhibit the growth of cancer cells in mice, Prof. Kim De Keersmaecker from KU LEUVEN in Belgium told MNT.

Other studies had already indicated that the commonly used antidepressant has anticancer activity, but there was no explanation for the cause of this. Weve been able to demonstrate that sertraline inhibits the production of serine and glycine, causing decreased growth of cancer cells.

Cancer cells and healthy cells are often reliant on the amino acids serine and glycine, which they extract from their environment. However, certain cancer cells produce serine and glycine within the cell. They can become addicted to this production.

This internal production of serine and glycine requires certain enzymes, and these enzymes have become targets for cancer researchers. Preventing them from functioning can starve the cancer cells.

Previous studies have identified inhibitors of serine/glycine synthesis enzymes, but none have reached the clinical trial stage. As the authors of a KU LEUVEN study note, because sertraline is a clinically used drug that can safely be used in humans, it might make a good candidate.

Prof. De Keersmaecker explained that when used with other therapeutics, the drug strongly inhibited the growth of cancer cells in the mice.

The authors of the study concluded: Collectively, this work provides a novel and cost efficient treatment option for the rapidly growing list of serine/glycine synthesis-addicted cancers.

Christy Maksoudian from the NanoHealth & Optical Imaging Group team at KE LEUVEN is excited about the promise of nanotechnology for the treatment of cancer. She told MNT that because of the unique properties that emerge at such a small scale, nanoparticles can be designed in a multitude of ways to exhibit specific behaviors in organisms.

Currently, she explained, many available nanoformulations in the clinic are composed of organic materials because of their biocompatibility and safety. In this context, organic refers to compounds that include carbon.

However, she explains that inorganic nanomaterials, which do not contain carbon, also hold promise for cancer treatment because they possess further functionalities.

For instance, some magnetic nanoparticles, such as those of superparamagnetic iron oxide, can be magnetically guided toward the tumor, while gold nanoparticles generate heat upon exposure to near-infrared light and can, therefore, be used for photothermal therapy (via tumor tissue ablation).

In short, it is possible to introduce gold nanoparticles to the bloodstream of people with cancer. From there, these nanoparticles accumulate in tumors because tumors have particularly leaky blood vessels. Once that region is exposed to near-infrared light, the gold nanoparticles heat up and, consequently, kill cancer cells.

Because of the potential of such broad range of nanomaterial designs, there are always novel cancer therapies being developed.

Christy Maksoudian

I am excited to take part in this movement with my work on copper oxide nanoparticles. Maksoudian and her colleagues use copper oxide nanoparticles doped with 6% iron.

Maksoudian told MNT that these nanoparticles exploit intrinsic metabolic differences between cancer cells and healthy cells to induce high levels of toxicity in cancer cells while only causing reversible damage in healthy tissue.

The fact that such cancer-selective properties can arise due to minor modifications of the nanoparticles at the nanoscale is truly extraordinary and reaffirms the significant role that nanomedicine can play in expanding the treatment landscape for oncology.

Cancer is complex, so approaches to its treatment must match that complexity. As the summaries above demonstrate, scientists are not short on ingenuity, and the battle against cancer continues at pace.

Read the first part of our series on cancer researchers and their exciting work here.

Read more from the original source:
Cancer research: New advances and innovations - Medical News Today

This article was originally published here

Breast Cancer Res Treat. 2021 Jun 4. doi: 10.1007/s10549-021-06258-9. Online ahead of print.

ABSTRACT

BACKGROUND: Hereditary breast and ovarian cancer syndrome (HBOC) and Lynch syndrome (LS), the most common inherited cancer syndromes, are attributed to a single heterozygous pathogenic variant (PV) in BRCA1/2 or in a DNA MMR gene, respectively. Little is known about the phenotype in double heterozygotes who carry PVs in both genes.

METHODS: Carriers of double-PVs in any DNA MMR gene and BRCA1/2 attending one of three tertiary oncogenetic clinics between 1/2005 and 1/2020 were identified by database search, and their relevant data were retrieved and analyzed.

RESULTS: Eleven double carriers from four seemingly unrelated Ashkenazi Jewish families were evaluated. All carried an Ashkenazi Jewish founder BRCA PV, BRCA2 c.5946delT/c.6174delT (n = 10) or BRCA1 c.185delAG (n = 1). Four carried the MSH2 c.1906G > C founder PV, and 3, the MSH6 c.3984_3987dupGTCA founder PV; 3 patients had the MSH6 c.3956_3957dup PV. Eight double carriers (73%) had cancer: breast cancer (5 cases, 2 bilateral), melanoma (2 cases), urothelial cancer (2 cases), and colon, endometrial, prostate, cutaneous squamous cell cancer, glioblastoma, gastric stromal tumor, and lymphoma (1 case each). Six carriers had 1-2 tumors, one had 3 tumors, and one had 5 primary tumors. Age at diagnosis of the first tumor was 36-76 years. All carriers met NCCN BRCA1/2 testing criteria, and 3 met the revised Bethesda guidelines.

CONCLUSIONS: This case series, supported by the literature, suggests that the phenotype of double MSH2/6 and BRCA1/2 carriers is not associated with early disease onset or a more severe phenotype. The findings have implications for improved genetic testing guidelines and treatment strategies.

PMID:34086170 | DOI:10.1007/s10549-021-06258-9

Original post:
Double heterozygotes of BRCA1/BRCA2 and mismatch repair gene pathogenic variants: case series and clinical implications - DocWire News

(India, Maharashtra, Pune)Report Covers the Detailed Pre and Post COVID-19 Impact Analysis on Direct-To-Consumer (DTC) Genetic Testing Market

This report conducts the global Direct-To-Consumer (DTC) Genetic Testing market size based on capacity, value, production and consumption data across the region such as North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa. This study categorizes the global Direct-To-Consumer (DTC) Genetic Testing breakdown data by manufacturers, region, type and application, also analyzes the market status, market share, market drivers, upcoming opportunities, CAGR, trends, and challenges, risks and entry barriers, sales channels, distributors, SWOT, PESTLE, and Porters Five Forces Analysis.

The Direct-To-Consumer (DTC) Genetic Testing Market is expected to grow from USD XX billion in 2020 to USD XX billion by 2027, at a Compound Annual Growth Rate (CAGR) of XX% during the forecast period. The research provides insights for the global Direct-To-Consumer (DTC) Genetic Testing market based on different types, end-users and regions, and competitive landscape of these segments is analysed in more detail.

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Various market influence factors are taken into consideration in the analysis, and potential developing factors for different types, end-users, regions, and countries are also included in the report in order to figure out the most promising development trends in the Direct-To-Consumer (DTC) Genetic Testing industry. The market capacity and consumption potential of more than 35 major players are covered in the research, providing valuable opinions of strategic adjustments for existing groups and new entrants, across the regions such as North America, Europe, Asia Pacific and Latin America, Middle East & Africa.

The Snapshot of Global Direct-To-Consumer (DTC) Genetic Testing Market Segmentations:

The Key Direct-To-Consumer (DTC) Genetic Testing Market Players Associated with the Industry are:, Color Genomics, Inc., Gene by Gene, Ltd., Laboratory Corporation of America Holdings, 23andMe, Inc., Sonora Quest Laboratories LLC, Request A Test, Ltd., Direct Laboratory Services, LLC, Mapmygenome India Limited, Any Lab Test Now, Ancestry.com, LLC, Xcode Life Sciences, Quest Diagnostics, Inc., Counsyl, Inc., Positive Bioscience, Inc.

Market, By Types:, Carrier Testing, Predictive Testing, Ancestry & Relationship Testing, Nutrigenomics Testing

Market, By Application:, Hospital, Doctors Office, Other

By Region, North America, U.S., Europe, UK, France, Germany, Asia Pacific, China, Japan, India, Latin America, Brazil, Middle East and Africa

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Key Reasons to Purchas: , To gain insightful analyses of the market and have comprehensive understanding of the global market and its commercial landscape., Assess the production processes, major issues, and solutions to mitigate the development risk., To understand the most affecting driving and restraining forces in the market and its impact in the global market., Learn about the market strategies that are being adopted by leading respective organizations., To understand the future outlook and prospects for the market., Besides the standard structure reports, we also provide custom research according to specific requirements.

Covid-19 Scenario, Post the COVID-19 infection global economy has been disrupted and our reports cannot afford to escape its impact, be it market engineering or write ups. All the reports published needs to consider this COVID pandemic since it is going it affect all the verticals and all the segments in which we operate and conduct market research.

The report covered 4 major scenarios which would affect the global markets post COVID-19 infection and it needs to consider them in our analysis as the new reports would be purely purchased by our clients to understand how would be the recovery of their respective markets occur over the time. The scenarios include:

There are 4 scenarios of recovery, 1) V shaped recovery rapid decline sharp bottom-rapid recovery, 2) U shaped recovery -rapid decline early- gradual at bottom slow recovery at first faster recovery later on, 3) L shaped recovery rapid decline then slow growth, 4) W shaped recovery -rapid decline rapid recovery- return of virus another sharp decline -recovery

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Some Point of Table of Content:

Chapter One: Direct-To-Consumer (DTC) Genetic Testing Introduction and Market Overview

Chapter Two: Executive Summary

Chapter Three: Industry Chain Analysis

Chapter Four: Global Direct-To-Consumer (DTC) Genetic Testing Market, by Type

Chapter Five: Direct-To-Consumer (DTC) Genetic Testing Market, by Application

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

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

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

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

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

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

Chapter Twelve: Competitive Landscape

Chapter Thirteen: Industry Outlook

Chapter Fourteen: Global Direct-To-Consumer (DTC) Genetic Testing Market Forecast

Chapter Fifteen: New Project Feasibility Analysis

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About us.The Market Insights is a sister company to SI Market research and The Market Insights is into reselling. The Market Insights is a company that is creating cutting edge, futuristic and informative reports in many different areas. Some of the most common areas where we generate reports are industry reports, country reports, company reports and everything in between. At The Market Insights, we give our clients the best reports that can be made in the market. Our reports are not only about market statistics, but they also contain a lot of information about new and niche company profiles. The companies that feature in our reports are pre-eminent. The database of the reports on market research is constantly updated by us. This database contains a broad variety of reports from the cardinal industries. Our clients have direct access online to our databases. This is done to ensure that the client is always provided with what they need. Based on these needs, we at The Market Insights also include insights from experts about the global industries, market trends as well as the products in the market. These resources that we prepare are also available on our database for our esteemed clients to use. It is our duty at The Market Insights to ensure that our clients find success in their endeavors and we do everything that we can to help make that possible.

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Direct-To-Consumer (DTC) Genetic Testing Comprehensive Analysis on Global Market Report by Company, by Dynamics, by Region, by Type, by Application...

This Cryonics Technology market report provides the best business insight and understanding to help key players stay ahead of the competition. It also detects emerging trends and forecasts future market numbers, trends, and characteristics. This Cryonics Technology market report offers the most effective action strategies for dealing with the current market situation and establishing a marketplace. It also helps to improve and enhance the companys position. This Cryonics Technology market report allows industries to easily assess and compare their results to that of others. This Cryonics Technology market report provides a straightforward view of market tactics, which can assist companies in achieving massive profits. It also offers a good picture of trade restraints, product releases, business penetration in new areas, and technical developments and advancements.

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Segmentation on the Basis of Application:Animal husbandry Fishery science Medical science Preservation of microbiology culture Conserving plant biodiversity

Global Cryonics Technology market: Type segmentsSlow freezing Vitrification Ultra-rapid

Table of Content1 Report Overview1.1 Product Definition and Scope1.2 PEST (Political, Economic, Social and Technological) Analysis of Cryonics Technology Market2 Market Trends and Competitive Landscape3 Segmentation of Cryonics Technology Market by Types4 Segmentation of Cryonics Technology Market by End-Users5 Market Analysis by Major Regions6 Product Commodity of Cryonics Technology Market in Major Countries7 North America Cryonics Technology Landscape Analysis8 Europe Cryonics Technology Landscape Analysis9 Asia Pacific Cryonics Technology Landscape Analysis10 Latin America, Middle East & Africa Cryonics Technology Landscape Analysis 11 Major Players Profile

Furthermore, this study sheds light on a few key points that will drive the global markets financial flow. It also focuses on a number of key sources that can be used in the market to achieve the best results and gains. It also covers some critical approaches for exploring global market opportunities and expanding the company. In this Cryonics Technology market report, a thorough regional study is carried out, with a focus on a few main regions such as Europe, China, North America, Japan, India, and South America. Key players can easily gain a prominent position in the market with the aid of this detailed market research. It also depicts the COVID-19 global effects on various segments and countries.

In-depth Cryonics Technology Market Report: Intended AudienceCryonics Technology manufacturersDownstream vendors and end-usersTraders, distributors, and resellers of Cryonics TechnologyCryonics Technology industry associations and research organizationsProduct managers, Cryonics Technology industry administrator, C-level executives of the industriesMarket Research and consulting firms

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About Global Market MonitorGlobal Market Monitor is a professional modern consulting company, engaged in three major business categories such as market research services, business advisory, technology consulting.We always maintain the win-win spirit, reliable quality and the vision of keeping pace with The Times, to help enterprises achieve revenue growth, cost reduction, and efficiency improvement, and significantly avoid operational risks, to achieve lean growth. Global Market Monitor has provided professional market research, investment consulting, and competitive intelligence services to thousands of organizations, including start-ups, government agencies, banks, research institutes, industry associations, consulting firms, and investment firms.ContactGlobal Market MonitorOne Pierrepont Plaza, 300 Cadman Plaza W, Brooklyn,NY 11201, USAName: Rebecca HallPhone: + 1 (347) 467 7721Email: info@globalmarketmonitor.comWeb Site: https://www.globalmarketmonitor.com

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Cryonics Technology Market Pegged for Robust Expansion by 2027 Covid-19 Analysis The Courier - The Courier

Cell and gene therapies (CGTs) are poised to revolutionize the landscape of biologic drugs that treat diseases and offer hope in areas where there was previously none. There are 20 FDA-approved CGTs, and this number is expected to grow significantly. Regulators predict that by 2025, they will approve 10 to 20 CGT products a year, based on an assessment of the current pipeline and the clinical success rates of these products. Pharma and biotech companies clearly recognize the potential of CGTs, with 16 out of 20 of the world's largest (by revenue) biopharma companies adding CGT assets to their product portfolios. Valuable insights into what drives progress, to new innovations on the horizon, and the critical challenges that sponsor companies face in developing these treatments were provided by Thomas VanCott, Ph.D., Vice President and Global Head of Product Development, Catalent Cell and Gene therapy. VanCott has over 15 years of experience bringing vaccines and many different therapies from clinical stages to the commercial marketplace, therefore providing a deep understanding of how to successfully navigate the CGT arena.

VanCott: Advancements in technology is a huge accelerator. Currently, the availability of manufacturing platforms and pathways can move these CGTs from the lab to the clinic in a reasonable time frame. Meanwhile, adeno-associated virus has proved to be a safe and flexible gene-delivery mechanism, and with the emergence of other suitable viral vectors and non-viral delivery methods, there are many viable options out there.

Another significant driver has been the early successes with products such as Kite's Yescarta and Novartis'Kymriah. Cell therapy is generating a lot of excitement, and it is not just limited to CART T-cells, but to widely divergent cell types, such as natural killer cells, macrophages and stem cells that are broadening CGT applications.

We have flexibility of viral and non-viral vectors for gene therapies, and different cell types to adapt for cell therapies. We have manufacturing processes in place that can get us into the clinic. Success generates excitement across the board, from scientists, patients and advocacy groups to investors. We have a lot of companies in the space, a lot of investment and a deep pipeline, which is making the future look very promising.

VanCott: Developing scalable manufacturing processes for CGTs within a reasonable cost is a critical challenge. The public is probably willing to pay more for some of these early therapies, but if these really become a staple in doctors'medical arsenals, we will need to work to get these prices down, and the best way to do that is to have more efficient and more scalable processes.

CGTs are so varied and complex that fully characterizing each product's activity is no trivial matter. Consequently, the development of better analytics will be a formidable challenge for this industry.

A lack of effective preclinical models to predict the safety of CGTs is another challenging area for sponsor companies. Safety issues with CGTs get a lot of attention; we need to strive to develop better models that can predict problems before moving these treatments to patients and commencing clinical trials.

The COVID-19 pandemic exacerbated a major problem for the CGT industry, that of supply chain shortages. We have only limited resources and raw materials, and so keeping your supply chain intact to continue manufacturing has definitely been one of the biggest challenges recently.

VanCott: I predict that future innovative therapies will be created using induced pluripotent stem cells. Even though these cells are really difficult to work with, they have almost unlimited applications because they can differentiate into any cell type.

Continued innovation in non-viral gene-delivery methods that will facilitate methods such as tissue-targeting and repeat dosing will propel CGT products forward. There's always been a lot of work in non-viral delivery, but we're seeing an acceleration of that because of the success of the Moderna and Pfizer COVID-19 vaccines that use lipid nanoparticles (LNPs) for effective delivery of mRNA. In fact, without these LNPs, there would be no mRNA vaccines for COVID-19.

Innovations in the field will lead to treatment of other diseases, such as diabetes, Parkinson's and macular degeneration, that affect much larger populations. Historically, CGT has been mostly reserved for treating rare diseases, but I am confident this will change in the near future. Higher-yield CGTs are needed for this to become a reality, and I foresee a surge in allogeneic cell therapies, which could mean having off-the-shelf types of products on the market. In addition, coupling cell therapies with some of these new gene-editing technologies, such as CRISPR/Cas9, you can start to further engineer cells to address countless therapeutic needs.

Data from clinical efficacy and safety of CGTs will unquestionably shape the field. There is great promise that ten years from now, we're going to have many new gene therapy treatments for monogenic diseases and certainly more cell therapies. CGTs are here to stay, and they're going to become an important part of a doctor's arsenal for treating patients.

VanCott: My advice to sponsor companies is to develop more robust processes early on to analyze the critical quality attributes of their products, to formulate their target product profile and to get their manufacturing process commercial-ready all within an earlier time frame. Typically, the development pathway for CGTs is much faster than with more conventional therapies. Instead of taking ten years to develop a product, you're cutting that time in half. Sponsor companies too often underestimate the importance and the time it takes to get the analytics optimized. Spending a significant time at the beginning of the development process to optimize each step and avoid moving forward in a rush with a process that is not rigorous and reproducible is very important.

Seek out CDMO partners that can handle accelerated timelines and give preference to those CDMOs with a fully integrated service offering. In the past, it was pretty standard for sponsor companies to work with a CDMO for the early-stage development, including tech transfer and process development, and maybe clinical Phase 1 and 2, then switch to another CDMO that had the larger-scale capacity and could handle Phase 3 and commercial stages of development. In today's CGT field, you do not have those long timelines, and clients do not have the luxury of switching CDMOs. Successful CDMOs need to offer everything from that initial tech transfer all the way up through commercial production.

Detailed and long-term planning is needed for establishing a reliable supply chain for CGT development. With the COVID-19 pandemic creating a strain on resources, it has not been easy recently to maintain a steady supply chain. However, there is some good news, in that the market will respond to increasing demands. As more companies start producing larger amounts of the needed supplies, and once we get through this initial high demand, there will be more supply making the scarcity of resources a temporary issue. As CGTs become approved for larger indications in the future, the ability of the supply chain to be ramped up, as it was for COVID-19 vaccines, will be a valuable element in the future success of these therapies for the wider population.

To hear from more of the industry's leading CGT specialists, register for the BioPharma Dive webinar, Gene Therapy at a Crossroads: The Challenges and Opportunities Ahead

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Innovation in cell and gene therapy: Insights from an industry specialist - BioPharma Dive

A five-month-oldbaby has become the first patient in England treated with a potentially life-saving drug on the NHS that can prolong the lives of children with spinal muscular atrophy.

rthur Morgan, who was diagnosed with the condition earlier this month, received the one-off gene therapy at Evelina London Childrens Hospital on May 25.

Until two years ago, there were no treatment options available for children with spinal muscular atrophy (SMA), which is the leading genetic cause of death for children.

But babies could potentially have the ability to sit, crawl and walk after being treated with US gene therapy Zolgensma, which has been labelled the most expensive drug in the world.

Zolgensma, which has a list price of 1.79m (2.08m)per dose, was made available on the NHS after the health service struck a deal with manufacturers Novartis Gene Therapies in March.

Baby Arthur, who was born six weeks premature in December, underwent the gene therapy infusion last week after being diagnosed with SMA less than three weeks earlier.

His father Reece Morgan (31) who works as a self-employed plasterer, said: When we found out that Arthur would get the treatment, and be the first patient, I just broke down.

It had been such a whirlwind few weeks, filled with lots of anxiety and adjustment as we learned about his condition and what it might mean for him and our family.

We still dont know what the future will hold, but this gives Arthur the best possible chance to give him the best possible future.

Babies born with Type 1 SMA, which is the most common form of the condition, experience progressive muscle weakness, loss of movement, difficulty breathing, and have a life expectancy of just two years.

Four NHS centres have now been commissioned across the country to administer the treatment, including Evelina London Childrens Hospital, where Arthur was treated.

NHS chief executive Sir Simon Stevens said: It is fantastic news that this revolutionary treatment is now available for babies and children like Arthur on the NHS.

The NHS Long Term Plan committed to securing cutting edge treatments for patients at a price that is fair to taxpayers.

Original post:
The 2m-a-dose therapy is just what doctor ordered for baby Arthur - Independent.ie

NEW YORK Myriad Genetics unveiled data at the American Society of Clinical Oncology's virtual annual meeting demonstrating that its polygenic score for assessing breast cancer risk can provide accurate estimates for women regardless of their ancestry.

The company launched riskScore three years ago initially as a test for estimating the five-year and lifetime risk of breast cancer for women who had never had the disease and who do not have a mutation in breast cancer-associated genes detected by its next-generation sequencing myRisk Hereditary Cancer test. However, the availability of the around 86-SNP polygenic risk score to date has been restricted to women who self-identified as having European and Ashkenazi Jewish ancestry.

Now, having recalibrated riskScore to provide more accurate breast cancer risk estimates for women in the US, regardless of their genetic ancestry, Myriad is planning to launch this version of the test later this year for women who qualify for myRisk, which gauges mutations in multiple genes conferring high or moderate risk for breast cancer. In 2022, the company will offer riskScore as a standalone, direct-to-consumer (DTC) test for women who aren't eligible for the myRisk test based on their personal and family history of breast cancer.

Polygenic risk scores rely on the combinatorial power of many SNPs associated with disease risk, but these SNPs have largely been identified in genome-wide association studies done in patients of European ancestry. As such, these scores tend to overestimate disease risk and are less accurate in discerning between high- and low-risk groups in those of non-European ancestry.

For example, studies have shown that Black women have similar incidence of breast cancer compared to white women in the US. But Myriad's 86-SNP riskScore developed for women of European ancestry overestimates the breast cancer risk in Black women by nearly twofold, said Holly Pederson, who was involved in the effort to recalibrate riskScore and directs medical breast services at the Cleveland Clinic.

Myriad wanted to address this limitation within its test and has been refining riskScore in Hispanic, African American, and other racial groups for several years. Pederson presented the culmination of those efforts at ASCO's annual meeting and unveiled a new 93-SNP riskScore, re-engineered for all ancestries using data from more than 275,000 women.

The new iteration of riskScore will not only test women for 93 breast cancer-associated SNPs, but also for 56 ancestry-associated genes, in order to calculate an ancestry-specific result that corresponds to their chances of developing breast cancer in the next five years and over their lifetime. This will preclude women from having to self-report their ancestry, which can be inaccurate, especially for non-European women. "What I found during my years of seeing patients is that many patients weren't entirely sure of their ancestry, and this will no longer be a barrier for care," said Nicole Lambert, president of Myriad Genetic Laboratories.

Weighted by genetic ancestry

The 93-SNP riskScore is weighted according to 56 SNPs associated with ancestral lineage from Africa, East Asia, and Europe, the three places that account for most of the genetic diversity in the US. "There are multiple sub-clusters within each of those [continental] clusters, so using three ancestries is a simplification of the full diversity of human populations," Pederson acknowledged during her presentation at the meeting. "However, these three ancestries together should reasonably represent most of US human genetic diversity."

Data from more than 189,000 women were used to develop the score, and it was validated in data from more than 89,000 women. In these cohorts, 23 percent of women had breast cancer and around 30 percent had a first-degree relative with the disease. Roughly 10 percent of women in these cohorts self-reported as Black or African, around the same proportion self-reported as Hispanic, and around 2 percent self-reported as Asian.

To develop the score, researchers led by Myriad CSO Jerry Lanchbury and Elisha Hughes, the company's director of research biostatistics, first developed polygenic risk scores specific to people of African, Asian, and European descent using data from its own hereditary cancer testing customers with self-reported race, as well as from large consortia and genome-wide association studies. For each of the patients in the development cohort, researchers determined their "fractional ancestry" from the three continents using the 56 SNPs, which then allowed for the ancestry-adjusted calculation of their risk for developing breast cancer based on the 93 SNPs.

"The different alleles found for each SNP in an individual woman are interpreted not only as a function of her ancestral composition, but also on the frequency of that allele's presence in one of the three continental ancestries because they are each different," Pederson said. "An individual woman's polygenic risk score therefore depends not only on her genotype, but also on her ancestral derivation and the frequency of an allele in a given ancestry."

In the validation cohort, researchers wanted to see how well the re-engineered riskScore distinguished between women at high and low-risk of developing breast cancer across ancestries and how the new score compared to the 86-SNP test for women of European descent. The study showed that the 93-SNP test was generally an improvement over the 86-SNP test in terms of breast cancer risk predictions for women of all ancestries. In their abstract, the authors noted that the Asian cohort was too small to demonstrate that either score was superior.

Furthermore, the validation study showed that the women with the recalibrated riskScore placed in the highest risk category the top 1 percent in fact had a two to threefold greater chance of developing breast cancer compared to average-risk women. For women of all self-reported ancestries, except Black women, if the test placed them in the top decile in terms of risk, they were twice as likely to develop breast cancer compared to average-risk women.

Self-reported African or Black women who were deemed by riskScore to be in the top decile in terms of risk had a 44 percent greater chance of developing breast cancer risk. Pederson said during her presentation that the re-engineered riskScore's ability to assess self-reported Black women's breast cancer risk was "significantly improved" compared to the earlier test but still "sub-optimal." She added that the new score's risk discrimination in Black women will likely become more precise with additional data.

"We have known for some time that genomically-based breast cancer risk stratification was biased towards SNPs from women with European ancestry and did not perform as well in women ofother ancestries," said Corey Speers, assistant professor of radiation oncology at the University of Michigan Rogel Cancer Center. "This study represents an important step to 'level the field' for women of disparate ancestries and more accurately estimate breast cancer risk in these women," Speers, who researches the biology of aggressive breast cancers and wasn't involved in the riskScore study, added.

More definitive guidance

Cleveland Clinic, where Pederson works, hasn't yet incorporated polygenic risk scores into standard disease risk estimation workflows. The academic medical center is participating in a prospective study, called GENRE-2, using a 300-SNP breast cancer polygenic risk score developed by Fergus Couch at the Mayo Clinic. In that study, researchers are tracking if this score helps patients make decisions about breast cancer prevention, such as whether to take endocrine therapy. https://clinicaltrials.gov/ct2/show/NCT04474834?term=GENRE-2&draw=2&rank

Outside of the research setting, however, the lack of validation in non-European populations has been a big reason holding up adoption of polygenic risk scores for breast cancer and other diseases. "Clinically, the polygenic risk score is really in its infancy," Pederson said. "Previous to this, really due to concerns over applicability in non-European populations and interpretation and communication of the results, we have not utilized polygenic risk scores at Cleveland Clinic."

Even though Myriad has been offering the 86-SNP riskScore for European women as part of myRisk at no additional cost, Cleveland Clinic has been opting out of that information, according to Pederson. This study, she believes, may very well change that, since to the best of her knowledge Myriad's test is the only breast cancer polygenic risk score that has been calibrated to be informative for all ancestries.

Speers noted as a positive that the training and validation cohorts in the study presented at ASCO included tens of thousands of women and were well balanced in terms of the factors that are most likely to influence breast cancer risk. He is eagerly awaiting peer-reviewed publication of the data, upon which he expects that riskScore will represent "an important step forward for providing equitable and accurate test results for women of all ancestral backgrounds."

With the increasing use of multi-gene tests, like myRisk, which look for pathogenic variants in moderate-risk genes alongside well-known high-risk genes like BRCA1/2, more patients are receiving results where the management implications aren't well established. This can be particularly difficult when women's personal or family history of cancer doesn't offer straightforward clues as to their future cancer risks.

Myriad and others developing polygenic risk scores are betting that these tests will providerisk information when large NGS panels turn up negative or even refine risk estimates when considered alongside mutations in moderate-penetrance genes, and relieve uncertainties around patient management. "If patients have a genetic mutation in CHEK2, which is a moderate-risk gene, we tell them they have an estimated lifetime [breast cancer] risk of about 30 percent," Pederson said. "But when you look at the risk stratification that can be achieved by a polygenic risk score, patients may have a risk as low as 6.6 percent over the course of her life or a 70 percent risk, which is similar to a patient with a BRCA1/2 [high-risk] mutation."

Women she treats overwhelmingly want to know this information, Pederson said.

Although she believes that Myriad's new riskScore is "sufficiently validated and calibrated" in all ancestries, she would like to see the test factor in patients' clinical features that also increase their chances of developing breast cancer. At her own practice, patients' decisions about having preventive mastectomies or oophorectomies to mitigate their cancer risk isn't just based on genetic testing but also on a variety of other clinical factors, as well as patients' own priorities for their health and family planning.

The genetic test result is "just one piece of information," she said. "While it is useful in and of itself, it'll be even more useful for a woman to get an estimate in combination with those other [clinical] factors. It just allows for more precise estimates and better conversations."

Myriad's 86-SNP score for European women incorporates the Tyrer-Cuzick risk model, which evaluates breast cancer risk based on features like age, body mass index, age of first period, and family history of cancer. Myriad is working on integrating clinical risk features into the recalibrated riskScore, Pederson said, adding that this work will likely be presented at a medical meeting by year end.

Access to all

Myriad is planning to launch the recalibrated riskScore for all ancestries later this year, but in the near-term will maintain it as a physician-ordered test offered alongside myRisk. Next year, however, the company wants to launch riskScore as a standalone test through a DTC model for the estimated 93 million women who don't qualify for testing for high- or moderate-penetrance breast cancer risk genes based on stringent personal and family cancer history criteria, as well as the National Comprehensive Cancer Network's guidelines. "This will allow us to provide a precise risk estimate to all women: myRisk for those who qualify, standalone riskScore for those who dont," said Lambert.

Myriad's DTC plans for riskScore also raises questions about how the company will navigate the regulatory landscape. The US Food and Drug Administration has been clear about its intent to regulate labs marketing genetic tests for assessing disease risk directly to consumers.

23andMe is the only company that currently sells FDA-authorized genetic tests for gauging disease risk, including for cancer, which people can order online without any physician involvement. Other companies offering testing in CLIA-certified labs have found ways around FDA oversight by using third-party physician networks to review and approve customer's online orders. However, this is a controversial model because often the physicians approving test orders don't have much interaction with the patients.

Myriad demurred on its specific regulatory plans, saying that it is still ironing out the specific DTC model it will employ when it launches riskScore as a standalone test next year. "We are currently assessing the regulatory requirements, talking with stakeholders, and creating the specific launch plans," Lambert said.

Pederson backed efforts to broaden access to cancer risk testing, recognizing that using current testing guidelines, largely based on personal and family history of cancer, the healthcare system has identified only a minority of patients with mutations in high-risk genes. At the same time, the rapid introduction of broad NGS panels has made it difficult for physicians lacking genetic expertise to accurately interpret test reports.

As such, a broad marketing strategy for polygenic risk scores must include a robust education plan for patients and providers, Pederson said, including genetic counseling support and resources to help primary care providers interpret test reports and relay nuanced risk information to patients.

Lambert assured that Myriad currently makes genetic counselors available to any doctor or patient ordering germline genetic testing and that these resources would also be available in the consumer-facing service. "We are in the process of evaluating what other services would be desirable as we prepare for the launch of the consumer version in 2022," she said.

Ultimately, given the popularity of DTC genetic testing, "something real like this, if it is priced right and marketed correctly, would really provide women with information that they really want," Pederson said.

See original here:
Myriad Genetics Recalibrates Breast Cancer PRS for All Ancestries in Anticipation of Broader Launch - Precision Oncology News

Breast cancer is caused by mutations, or damage, to the DNA in breast cells. Exactly what triggers this change is unknown, but many people will spend countless hours trying to figure it out.

What is known is that there are risk factors that may increase your chances of getting breast cancer. Some of them, like age, family history, and dense breasts, cant be changed. Others are determined by lifestyle factors that can often be controlled.

In the United States, its estimated that around 30% of new cancer diagnoses in women will be breast cancer. This makes early detection and possible prevention very important. In this article, well go over the potential causes of breast cancer and what you can do about them.

Breast cancer originates in breast tissue. Its caused by changes, or mutations, in breast cell DNA. These mutations cause cells to grow abnormally and divide quicker than healthy cells do. The abnormal cells accumulate, forming a malignant breast mass, also known as a lump.

Your immune system may be able to successfully fight some abnormal cells. but the ones that continue to grow may spread, or metastasize, throughout the breast to the lymph nodes or other parts of the body.

When breast cancer spreads, the malignant tumors it causes in other places are still referred to as breast cancer.

What exactly triggers DNA changes in breast cells isnt clear. Two people can have the same or similar risk factors, but only one might develop breast cancer.

Age is the most significant risk factor for breast cancer. Most breast cancer cases are diagnosed in people over 55 years old.

But your genetics and external factors, like smoking, also have an impact. Genetic risk factors cant be changed, but lifestyle choices that put you at higher risk can be altered.

Its also likely that for many people, multiple risk factors both genetic and environmental have an impact when several are present.

People born with a vagina are at a significantly higher risk for getting breast cancer than those born without one. According to the Centers for Disease Control and Prevention (CDC), only about 1 in every 100 cases of breast cancer diagnosed in the United States is in a man.

You can inherit a gene mutation that puts you at higher risk for breast cancer from either biological parent. About 5 to 10 percent of all breast cancer cases are caused by hereditary gene mutations. The most common type is a mutation in the BRCA1 or BRCA2 gene.

If you have a BRCA1 or BRCA2 gene mutation, your risk for ovarian cancer is also increased.

There are other inherited gene mutations that can increase your risk as well, including:

If you have several close relatives with breast cancer, you may be more likely to develop it. This is especially true if you have one or more first-degree relatives with breast cancer. A first-degree relative is anyone you share at least 50 percent of your genetics with, like a parent or child.

Having a family history of breast cancer may mean you share the same genetic mutation. But there are other potential explanations here that have nothing to do with genetics.

For example, it may mean you share lifestyle choices that put you at greater risk. It may also be caused by environmental factors, like living in an area where chemical exposure, air pollution, or water pollution levels are high.

You may be more likely to develop ER-positive breast cancer if you began menstruating at a younger age or started menopause later than usual. This is because theres a longer period of time when breast cells are affected by estrogen and possibly, progesterone.

Never having given birth also increases your lifetime exposure to estrogen.

If you have given birth, every 12 months that you nurse your child reduces your chance of getting breast cancer by about 4.3 percent.

Smoking cigarettes and using nicotine products modestly increases the risk for breast cancer. The younger you were when you started smoking, the greater your risk. Smoking also increases your risk to a greater degree if you have a family history of the disease.

The International Agency for Research on Cancer has determined that alcohol is a carcinogen thats causally related to breast cancer risk.

The greater your alcohol intake, the higher your risk may be. But even one drink per day increases risk in both premenopausal and postmenopausal women.

Toxins and chemicals can be found in:

Some toxins are known as endocrine disruptors, or endocrine disrupting compounds. These toxins can mimic the effects of estrogen in the body and may increase breast cancer risk. Endocrine disruptors include:

Certain foods may increase your risk of breast cancer. Foods to limit or avoid include:

Because fat cells produce estrogen, being overweight or obese can be a significant risk factor as is having a sedentary lifestyle, which may contribute to increased weight.

Women whove previously had breast cancer or are postmenopausal have an even higher risk if theyre overweight or are living with obesity.

Hormonal birth control, including the pill, ring, and IUD, may increase your breast cancer risk slightly. This may be greater if you use hormonal birth control for 5 years or more. If you have a family history of breast cancer, your risk may be higher.

Hormone replacement therapy (HRT) poses a much greater risk. HRT isnt recommended for symptom relief of menopause in people who have other risk factors for breast cancer.

Early detection wont stop you from getting breast cancer, but it can help to ensure a better outcome. Talk with a doctor about how often you should get a mammogram. If you have dense breasts, getting regular ultrasounds may also be beneficial.

Adjustments to your lifestyle may also help. These include:

The following tips may aid with recovery and with avoiding breast cancer recurrence:

Breast cancer is caused by mutations in breast tissue cells. The underlying risk factors for breast cancer include genetics, environmental toxins, and lifestyle factors, but a definite cause hasnt been identified.

Make proactive choices to reduce your risk of breast cancer. These include cutting down on smoking and alcohol use, as well as maintaining a healthy weight.

Go here to read the rest:
Breast Cancer Causes: Genetics, Prevention, and More - Healthline

EAST HANOVER, N.J., June 3, 2021 /PRNewswire/ -- Novartis today reported the final analysis from the NETTER-1 phase III study comparing treatment using Lutathera (INN: lutetium (177Lu) oxodotreotide / USAN: lutetium Lu 177 dotatate) plus 30 mg octreotide LAR to 60 mg of octreotide LAR in patients with midgut neuroendocrine tumors. The previously reported primary analysis of the trial demonstrated a statistically significant improvement in progression free survival (PFS) (HR: 0.18*, p < 0.0001)3. In the final analysis of overall survival, a secondary objective of the trial, treatment with Lutathera resulted in a clinically relevant prolongation in median overall survival of 11.7 months [48.0 months (95%CI: 37.4-55.2) compared to the control arm (36.3 months (95%CI: 25.9-51.7)]1.While this analysis did not reach statistical significance (Hazard ratio for OS (HR): 0.84 with 95% CI: (0.60, 1.17) (p=0.30, two-sided))1, the analyses of overall survival may have been impacted by multiple factors, including the crossover of patients from the control arm receiving subsequent radioligand therapy (36% of patients) as well as heterogenous subsequent anti-cancer treatments in both study arms1.No new safety signals emerged in the final analysis1. These results will be presented during the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting on June 4.

Jonathan Strosberg, MD, Principal Investigator and Associate Professor, Section Head, Neuroendocrine Tumor Program at Moffitt Cancer Center, said, "Lutathera plus long-acting octreotide was associated with a nearly 12-month difference in median overall survival compared to high-dose long-acting octreotide in these difficult to treat patients with inoperable midgut NETs progressing under standard dose octreotide LAR treatment.While not statistically significant, I consider this difference to be clinically relevant for these patients. It is also important to emphasize that PFS was the primary endpoint of this study.Moreover, 36% of patients in the control arm crossed over to receive subsequent radioligand treatment, which may have impacted the comparison of survival between both study arms."

"We are proud of our 30-year legacy as an innovator for patients in the neuroendocrine tumor community," said John Tsai, Head of Global Drug Development and Chief Medical Officer for Novartis. "Since its approval by the European Commission in 2017 and the FDA in 2018, Lutathera has been administered to more than 9,000 gastroenteropancreatic neuroendocrine tumor (GEP-NET) patients in Europe and the United States1. We believe in the potential of targeted radioligand therapy and are investing in new discovery and expansion of this important platform, including exploration of new radioisotopes and combinations with complementary mechanisms of action, such as immunotherapy and inhibitors of DNA damage response."

At this final analysis, no new safety signals emerged in the long-term safety follow-up with a median of 6.3 years. In terms of secondary hematological malignancies, no new cases of MDS or acute leukemia were reported in the long term follow up4.

Radioligand therapy combines a targeting compound that binds to receptors expressed by tumors and a radioactive isotope, causing DNA damage that inhibits tumor growth and replication and may lead to cell death5-7. In the case of Lutathera, it binds to somatostatin receptor type 2, which is over-expressed on certain types of cells, such as gastroenteropancreatic neuroendocrine tumor cells8,9.

Novartis has established global expertise and specialized supply chain and manufacturing capabilities across its network of four radioligand therapy production sites, and is further increasing capacity to ensure delivery of future targeted radioligand therapies to patients in need. Novartis is the only pharmaceutical company which is pursuing four different cancer treatment platforms. These include targeted radioligand therapy, cell and gene therapy, targeted therapy and immunotherapy, with an opportunity to combine these platforms for the best outcomes for each cancer patient.

Visithttps://www.hcp.novartis.com/virtual-congress/a-2021/for the latest information from Novartis, including our commitment to the Oncology community, and access to our ASCO21 Virtual Scientific Program data presentations (for registered participants).

* HR: 0.21 (0.13, 0.32) in the US Package Insert

About NETTER-1NETTER-1 is a Phase III international, multicenter, controlled, randomized study that compared treatment using Lutathera every eight weeks plus best standard of care (octreotide LAR 30 mg) to 60 mg of octreotide LAR (dosed every four weeks) in patients with inoperable midgut NETs progressing under standard dose octreotide LAR treatment and overexpressing somatostatin receptors3.

The primary endpoint was to compare the progression-free survival (PFS) after treatment with Lutathera plus octreotide LAR 30 mg versus octreotide LAR 60 mg using RECIST 1.1 criteria3. Secondary trial endpoints included comparing objective response rate, overall survival, time to tumor progression, duration of response and safety between the two study arms3.

About GEP-NETs Neuroendocrine tumors (NETs) are a type of cancer that originate in neuroendocrine cells throughout the body. NETs are commonly considered slow-growing malignancies. However, some NETs are associated with rapid progression and poor prognosis10-11. In many cases, NET diagnosis is delayed until patients have advanced disease12. Symptoms such as fatigue, diarrhea, and abdominal pain can occur on a daily basis13. Gastroenteropancreatic neuroendocrine tumors (GEP-NETs) are subdivided into two categories: tumors of the gastrointestinal (GI) tract and pancreas14. There is a need for additional treatment options for inoperable or advanced GEP-NET, including those who have progressed while taking first-line somatostatin analogs.

The estimated age-adjusted incidence, or rate of new cases of NETs in the United States is approximately 6.98/100,000 per year (as of 2012), while the estimated 20-year limited-duration prevalence for 2014, based on the National Cancer Institute's Surveillance, Epidemiology, and End Results (SEER) database, was 171,32111. Even though NETs have historically been considered to be rare (orphan disease), their incidence has grown over 500% over the last 3 decades 10,11,12,15.

About LutatheraLutathera (lutetium Lu 177 dotatate) is an Advanced Accelerator Applications product approved in the United States for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut and hindgut neuroendocrine tumors in adults16.

Lutathera (lutetium (177Lu) oxodotreotide) is also approved in Europe for the treatment of unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adults3.

Important Safety InformationLUTATHERA(lutetium Lu 177 dotatate) is a prescription medicine used to treat adults with a type of cancer known as gastroenteropancreatic neuroendocrine tumors (GEP-NETs) that are positive for the hormone receptor somatostatin, including GEP-NETs in the foregut, midgut, and hindgut.

LUTATHERA is associated with some serious safety considerations, and in some cases these may require a healthcare provider to adjust or stop treatment. Treatment with LUTATHERA will expose patients to radiation which can contribute to long-term radiation exposure. Overall radiation exposure is associated with an increased risk for cancer. The radiation will be detectable in urine for up to 30 days following administration of the drug. It is important to minimize radiation exposure to household contacts consistent with good radiation safety practices as advised by your healthcare provider. Treatment with LUTATHERA increases the risk of myelosuppression, a condition in which bone marrow activity is decreased, resulting in a drop in blood cell counts. You may experience blood-related side effects such as low red blood cells (anemia), low numbers of cells that are responsible for blood clotting (thrombocytopenia), and low numbers of white blood cells (neutropenia). Speak with your healthcare provider if you experience any signs or symptoms of infection, fever, chills, dizziness, shortness of breath or increased bleeding or bruising. Other serious conditions that you may develop as a direct result of treatment with LUTATHERA include blood and bone marrow disorders known as secondary myelodysplastic syndrome and cancer known as acute leukemia. Your healthcare provider will routinely check your blood cell counts and tell you if they are too low or too high. Treatment with LUTATHERA will expose kidneys to radiation and may impair their ability to work as normal. You may be at an increased risk for kidney problems after LUTATHERA treatment if you already have kidney impairment before treatment. In some cases, patients have experienced kidney failure after treatment with LUTATHERA. Your healthcare provider will provide you with an amino acid solution before, during, and after LUTATHERA to help protect your kidneys. You should stay well hydrated before, during, and after your treatment. You should urinate frequently during and after administration of LUTATHERA. Your doctor will monitor your kidney function and may withhold, reduce, or stop your LUTATHERA treatment accordingly. In clinical studies of LUTATHERA, less than 1% of patients were reported to have tumor bleeding (hemorrhage), swelling (edema) or tissue damage (necrosis) to the liver. If you have tumors in your liver, you may be more likely to experience these side effects. Signs that you may be experiencing liver damage include increases in blood markers called ALT, AST and GGT. Your healthcare provider will monitor your liver using blood tests and may need to withhold, reduce, or stop your LUTATHERA treatment accordingly. During your treatment you may experience certain symptoms that are related to hormones released from your cancer. These symptoms may include flushing, diarrhea, difficulty breathing (bronchospasm), and low blood pressure (hypotension), and may occur during or within the 24 hours after your first LUTATHERA treatment. Your healthcare provider will monitor you closely. Speak with your healthcare provider if you experience any of these signs or symptoms. Tell your healthcare provider if you are pregnant. LUTATHERA can harm your unborn baby. Females should use an effective method of birth control during treatment and for 7 months after the final dose of LUTATHERA. Males with female partners should use an effective method of birth control during treatment and for 4 months after the final dose of LUTATHERA. You should not breastfeed during treatment with LUTATHERA and for 2.5 months after your final dose of LUTATHERA. Treatment with LUTATHERA may cause infertility. This is because radiation absorbed by your testes or ovaries over the treatment period falls in the range of exposure where temporary or permanent infertility may occur.

The most common and most serious side effects of LUTATHERA include: vomiting, nausea, decreased blood cell counts, increased liver enzymes, decreased blood potassium levels, and increased blood glucose. Talk to your doctor if you experience any of these, or any other side effects.

Tell your healthcare provider if you are taking any other medications. Somatostatin analogs and corticosteroids may affect how your LUTATHERA treatment works. You should stop taking your long-acting somatostatin analog at least 4 weeks before LUTATHERA treatment. You may continue taking short-acting somatostatin analogs up to 24 hours before your LUTATHERA treatment. Avoid repeated high doses of glucocorticosteroids during treatment with LUTATHERA.

Please see fullPrescribing Informationfor LUTATHERA.

Disclaimer

This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as "potential," "can," "will," "plan," "may," "could," "would," "expect," "anticipate," "seek," "look forward," "believe," "committed," "investigational," "pipeline," "launch," or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases such as COVID-19; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About Advanced Accelerator Applications S.A. Advanced Accelerator Applications, S.A. (AAA), a Novartis company, is developing targeted radioligand therapies and precision imaging radioligands for oncology indications. We are committed to transforming patients' lives by leading innovation in nuclear medicine. AAA has a legacy as a leader in radiopharmaceutical drugs for Positron Emission Tomography (PET) and Single-Photon Emission Computed Tomography (SPECT) diagnostic imaging. For more information, please visit: https://www.adacap.com

About NovartisNovartis is reimagining medicine to improve and extend people's lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world's top companies investing in research and development. Novartis products reach nearly 800 million people globally and we are finding innovative ways to expand access to our latest treatments. About 110,000 people of more than 140 nationalities work at Novartis around the world. Find out more at https://www.novartis.com

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SOURCE Novartis Pharmaceuticals Corporation

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Novartis reports clinically relevant improvement in median overall survival data in final analysis of pivotal NETTER-1 study with targeted radioligand...