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Category Archives: Genetic Medicine

Push Is On in US to Figure Out South Asians High Heart Risks – Kaiser Health News

For years, Sharad Acharyas frequent hikes in the mountains outside Denver would leave him short of breath. But a real wake-up call came three years ago when he suddenly struggled to breathe while walking through an airport.

An electrocardiogram revealed that Acharya, a Nepali American from Broomfield, Colorado, had an irregular heartbeat on top of the high blood pressure he already knew about. He had to immediately undergo triple bypass surgery and get seven stents.

Acharya, now 54, thought of his late father and his many uncles who have had heart problems.

Its part of my genetics, for sure, he said.

South Asian Americans people with roots in Nepal, India, Pakistan, Sri Lanka, Bangladesh, Bhutan and the Maldives have a disproportionately higher risk of heart disease and other cardiovascular ailments. Worldwide, South Asians account for 60% of all heart disease cases, even though at 2 billion people they make up only a quarter of the planets population.

In the United States, theres increasing attention on these risks for Americans of South Asian descent, a growing population of about 5.4 million. Health care professionals attribute the problem to a mix of genetic, cultural and lifestyle influences but researchers are advocating for more resources to fully understand it.

Rep. Pramila Jayapal (D-Wash.) is sponsoring legislation that would direct $5 million over the next five years toward research into heart disease among South Asian Americans and raising awareness of the issue. The bill passed the U.S. House in September and is up for consideration in the Senate.

The issue could gain more attention after Sen. Kamala Harris (D-Calif.) becomes the nations first vice president with South Asian lineage. Harris mother, Shyamala Gopalan, moved from India to the U.S. in 1958 to attend graduate school. Gopalan, a breast cancer researcher, died in 2009 of colon cancer.

A 2018 study for the American Heart Association found South Asian Americans are more likely to die of coronary heart disease than other Asian Americans and non-Hispanic white Americans. The study pointed to their high incidences of diabetes and prediabetes as risk factors, as well as high waist-to-hip ratios. People of South Asian descent have a higher tendency to gain visceral fat in the abdomen, which is associated with insulin resistance. They also were found to be less physically active than other ethnic groups in the U.S.

One of the nations largest undertakings to understand these risks is the Mediators of Atherosclerosis in South Asians Living in America study, which began in 2006. The MASALA researchers, from institutions such as Northwestern University and the University of California-San Francisco, have examined more than 1,100 South Asian American men and women ages 40-79 to better understand the prevalence and outcomes of cardiovascular disease. They stress that high blood pressure and diabetes are common in the community, even for people at normal weights.

Thats why, said Dr. Alka Kanaya, MASALAs principal investigator and a professor at UCSF, South Asians cannot rely on traditional body mass index metrics, because BMI numbers considered normal could provide false reassurance to those who might still be at risk.

Kanaya recommends cardiac CT scans, which she said help identify high-risk patients, those who need to make more aggressive lifestyle changes and those who may need preventive medication.

Another risk factor, this one cultural, is diet. Some South Asian Americans are vegetarians, though its often a grain-heavy diet reliant on rice and flatbread. The AHA study found risks in such diets, which are high in refined carbohydrates and saturated fat.

We have to understand the cultural nuances [with] an Indian vegetarian diet, said Dr. Ronesh Sinha, author of The South Asian Health Solution and an internal medicine physician. That means something totally different than a Westerner whos going to be consuming a lot of plant-based protein and tofu, eating lots of salads and things that typical South Asians dont.

But getting South Asians to change their eating habits can be challenging, because their culture expresses hospitality and love through food, according to Arnab Mukherjea, an associate professor of health sciences at California State University-East Bay. One of the things South Asians tend to take a lot of pride in is transmitting cultural values and norms knowledge to the next generation, Mukherjea said.

The intergenerational transmission goes both ways, according to MASALA researchers. Adult, second-generation South Asian Americans might be the key to helping those in the first generation who are resistant to change adopt healthier habits, according to Kanaya.

In the San Francisco Bay Area, El Camino Hospitals South Asian Heart Center is one of the nations leading centers for educating the community. Its three locations are not far from Silicon Valley tech giants, which employ many South Asian Americans.

The centers medical director, Dr. Csar Molina, said the center treats many relatively young patients of South Asian descent without typical risk factors for cardiovascular disease.

It was like the typical 44-year-old engineer with a spouse and two kids showing up with a heart attack, he said.

The South Asian Health Center helps patients make lifestyle changes through meditation, exercise, diet and sleep. The nearby Palo Alto Medical Foundations Prevention and Awareness for South Asians program and the Stanford South Asian Translational Heart Initiative provide medical support for the community. Even patients in the later stages of heart disease can be helped by lifestyle changes, Sinha said.

Dr. Kevin Shah, a University of Utah cardiologist who co-authored the AHA study, said people with diabetes, hypertension and obesity are also at higher risk of COVID-19 complications so should now especially work to improve their cardiovascular health and fitness.

In Colorado, Acharyas health is still an issue. He said he had to get four more stents this year, and the surgeries have put pressure on his family. But hes breathing well, watching what he eats and once more exploring his beloved mountains.

Nowadays, I feel very, very good, he said. Im hiking a lot.

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Push Is On in US to Figure Out South Asians High Heart Risks - Kaiser Health News

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Worldwide Companion Diagnostic Industry to 2025 – Featuring Abbott Diagnostics, AccuraGen and Aethlon Medical Among Others – ResearchAndMarkets.com -…

DUBLIN--(BUSINESS WIRE)--The "Companion Diagnostic Markets - the Future of Diagnostics, by Funding Source and Application with Customized Forecasting/Analysis, COVID-19 Updates, and Executive and Consultant Guides 2021-2025" report has been added to ResearchAndMarkets.com's offering.

Companion Diagnostics are poised to revolutionize the diagnostics industry. The market is finally moving out of the lab and into the clinic. Oncology, especially immune-oncology is leading the way. And the FDA is holding the door open for this diagnostic technology of the future. But COVID-19 is impacting healthcare treatment everywhere and lowering demand for specialized cancer testing. Find out the latest outlook for this important market.

Learn all about how diagnostic players are jockeying for position with their pharmaceutical counterparts and creating new and significant business opportunities. And some players are already taking the lead. It is a dynamic market situation with enormous opportunity. Diagnostic companies are trying to back the right horse. The science is racing forward. And the cost of molecular diagnostics continues to fall.

This report provides data that analysts and planners can use. Hundreds of pages of information including a complete list of Current 2020 United States Medicare Fee Payment Schedules to help understand test pricing in detail. Forecast demand for new testing regimes or technologies. Make research investment decisions. Existing laboratories and hospitals can use the information directly to forecast and plan for clinical facilities growth.

The report includes detailed breakouts for 18 Countries and 4 Regions.

Companion Diagnostic Market - Strategic Situation Analysis

Companies Mentioned

Key Topics Covered:

1. Introduction and Market Definition

2. Market Overview

2.1 Players in a Dynamic Market

2.2 Personalized Medicine and Companion Diagnostics

2.3 Chromosomes, Genes and Epigenetics

2.4 Cancer Genes

2.5 Structure of Industry Plays a Part

3. Market Trends

3.1 Factors Driving Growth

3.1.1 Level of Care

3.1.2 Immuno-oncology

3.1.3 Liability

3.1.4 Aging Population

3.2 Factors Limiting Growth

3.2.1 State of knowledge

3.2.2 Genetic Blizzard.

3.2.3 Protocol Resistance

3.2.4 Regulation and coverage

3.3 Instrumentation and Automation

3.3.1 Instruments Key to Market Share

3.3.2 Bioinformatics Plays a Role

3.4 Diagnostic Technology Development

4. Companion Diagnostics Recent Developments

4.1 Recent Developments - Importance and How to Use This Section

4.1.1 Importance of These Developments

4.1.2 How to Use This Section

5. Profiles of Key Players

6. The Global Market for Companion Diagnostics

6.1 Global Market Overview by Country

6.2 Global Market by Application - Overview

6.3 Global Market Funding Source - Overview

7. Global Companion Diagnostic Markets - By Application

7.1 Oncology

7.2 Neurology

7.3 Cardiology

7.4 Other Application

8. Global Companion Diagnostic Markets - Funding Source

8.1 Global Market Pharmaceutical

8.2 Global Market Venture

8.3 Global Market Clinical

8.4 Global Market Other Funding

For more information about this report visit https://www.researchandmarkets.com/r/ur5vbq

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Worldwide Companion Diagnostic Industry to 2025 - Featuring Abbott Diagnostics, AccuraGen and Aethlon Medical Among Others - ResearchAndMarkets.com -...

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Baylor Genetics Launches Combination Test for COVID-19 and Influenza A and B; Multi-Panel Test Seeks to Address Dilemma of "Overlapping symptoms…

HOUSTON, Nov. 17, 2020 /PRNewswire/ --With the arrival of flu season, Baylor Genetics, a pioneer of genetic testing and precision medicine, has launched the latest combination test for the novel coronavirus, SARS-CoV-2, and Influenza A and B.

"Baylor Genetics created the combination COVID-19 and flu test because the symptoms between the two are so similar, but the treatments are undeniably different," stated Kengo Takishima, President & Chief Executive Officer at Baylor Genetics. "This groundbreaking test, with results available in 48 hours or less, will result in better data and more accurate treatments for these similar, but distinct, viruses."

In response to the global pandemic, Baylor Genetics validated its first test for COVID-19 in June 2020. Once launched, the company continued to focus on innovative efforts to help prevent the spread of the disease. Some of these efforts include unique partnerships with the City of Houston and Rice University. With their latest COVID-19 (SARS-CoV-2) & Flu (Influenza A/B) RT-PCR test, individuals will be able todetermine if they are currently infected with COVID-19 or the flu.

"The clinical presentations of COVID-19 and influenza are similar, and it is difficult to differentiate the two entities on symptoms alone," stated Dr. Christine Eng, Chief Medical Officer and Chief Quality Officer at Baylor Genetics. "This combination test will identify if SARS-CoV-2 or influenza A/B is the culprit, thus helping you and your healthcare provider better direct your care. Of course, it's important to stay proactive this season and get your flu shot if you haven't already."

Since many are traveling during the holidays, it is imperative that individuals know whether they are infected with either COVID-19 or the flu and how to treat each virus. While these respiratory viruses have similar symptoms, their treatments are different. For COVID-19, potential treatment and vaccine options are emerging. For the flu, antiviral medications can help address symptoms and potentially shorten the time an individual is sick. Therefore, it is crucial for individuals to be able to confirm which virus they may be infected with to take the proper next steps to restore their health.

For the COVID-19 and flu combination test, all sample results will be sent to individuals securely and electronically within 48 hours of Baylor Genetics' receiving the sample. In addition, the results will be automatically reported to state officials to track and slow the spread of cases in the local community. With accepted sample types of nasal or nasopharyngeal swab, all of the supplies for testing and returning the kit is provided to the individual.

To learn more about Baylor Genetics' test for COVID-19, visit https://www.baylorgenetics.com/covid19/.

About Baylor GeneticsBaylor Genetics is a joint venture of H.U. Group Holdings, Inc. and Baylor College of Medicine, including the #1 NIH-funded Department of Molecular and Human Genetics. Located in Houston's Texas Medical Center, Baylor Genetics serves clients in 50 states and 16 countries.

To learn more about Baylor Genetics visit http://www.baylorgenetics.com.

SOURCE Baylor Genetics

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UCB inks Handl buyout to boost nascent gene therapy unit – FierceBiotech

UCB has struck a deal to buy gene therapy startup Handl Therapeutics. The takeover, which was disclosed alongside a separate gene therapy collaboration, positions UCB to accelerate its push into genetic medicines.

In recent years, UCB has quietly built out its genetic medicine capabilities, buying Element Genomics for a small sum in 2018 while hiring gene therapy specialists and creating plans to refurbish an ex-Eli Lilly R&D site to support its aspirations in the area. Those efforts have been overshadowed by the big-ticket gene therapy deals struck by UCBs peers but point to its interest in the space.

UCB stepped up its gene therapy expansion on Thursday with two deals. UCB has bought Handl for an undisclosed sum to gain control of technology platforms designed to facilitate the development of AAV gene therapy treatments for complex neurodegenerative diseases.

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Handl was founded by Florent Gros, a Novartis veteran, and Michael Linden, an AAV expert who set up the Pfizer Genetic Medicine Institute in London. Working out of Leuven, Belgium, Handl has used the expertise and connections of Gros, its CEO, and Linden, its CSO, to identify and license technologies from Spain, Chile, the U.K. and Belgium.

The Chilean and Spanish academic centers that struck licensing deals with Handl put out statements about their work, disclosing an interest in treating diseases including Alzheimers, amyotrophic lateral sclerosis and Parkinsons. Handl entered into a manufacturing contract with Novasep earlier this month, securing support as it wraps up ongoing IND-enabling studies and moves into the clinic.

As part of UCB, the Handl team will continue to work on that program and other projects from its base in Leuven. UCBs international research teams will collaborate with the Handl group.

UCB disclosed the Handl takeover alongside details of a collaboration with Lacerta Therapeutics, a Florida-based AAV gene therapy startup. The deal gives UCB access to Lacertas pipeline of CNS gene therapies. Lacerta will handle research, preclinical and early process development, leaving UCB to focus on IND-enabling studies and subsequent manufacturing work and clinical development.

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Molecular Testing With Universal Method Comparable to Traditional Method in Hereditary Solid Tumors – Targeted Oncology

In multiple solid malignancies, including breast, ovarian, colorectal, and pancreatic cancers, there is a subset of patients with a hereditary predisposition for these diseases, but the current testing criteria do not mention this subset. In an effort to provide more information of genetic testing in this population, a study of Memorial Sloan Kettering Cancer Center (MSKCC) patients was conducted to test the traditional guideline-based method of testing versus universal testing of a broad cancer patient population over a 5-year period.

A total of 7235 patients were included in the analysis and tested for 76 to 88 cancers. Through this study, investigators uncovered pathogenic and likely pathogenic (P/LP) variants in 7.5% (95% CI 6.6%- 8.4%) of 3,341 patients with breast cancer, 17.4% (95% CI, 14%- 21.6%) of 384 those with ovarian cancer, 13.5% (95% CI, 9.8%- 18%) of 252 patients with colorectal, and 8.8% (95% CI, 5.1%-14.8%) of 136 patients with pancreatic cancer.

Overall, the study found that testing with universal method was comparable to the guideline-based method, implying that universal testing can expand genetic testing to patient populations who are in need but are currently underserved.

In an interview with Targeted Oncology during the 2020 Association for Molecular Pathology (AMP) Annual Meeting, Ozge Ceyhan-Birsoy, PhD, assistant directorof the Laboratoryfor Molecular Medicine, MSKCC, discussed genetic testing methods for patients with hereditary predisposition and the molecular research underway at MSKCC to improve testing in this patient population.

TARGTED ONCOLOGY: In recent years, what advances have we see in cancer genetics?

Ceyhan-Birsoy: There have been significant advances in the range of genetic testing options for cancer patients in recent years. More patients are now able to receive molecular testing on their tumors to identify optimal targeted therapies for their cancer and germline genetic testing to uncover hereditary cancer predisposition. A paired analysis of tumor and normal DNA is increasingly being adapted, which improves the interpretation of both somatic and germline mutations. Additionally, incorporation of RNA analysis has expanded the scope of mutations that can be detected and characterized. Finally, the use of cell-free DNA now allows us to profile a patients tumor using only their blood.

TARGETED ONCOLOGY: How can hereditary predisposition inform oncologist for care/treatment decisions?

Ceyhan-Birsoy: Identifying hereditary mutations that predispose patients to cancer has important implications for their treatment and management. There are established targeted therapies available now for certain germline defects. For instance, germline mutations in certain homologous recombination and mismatch repair genes can predict response to PARP inhibitor and immune-checkpoint inhibitor therapies, respectively. Some therapies may pose high risk for patients with particular gene mutations, such as radiation therapy risks for patients with germline TP53 mutations. In addition, identifying hereditary cancer predisposition is critical to allow timely surveillance and prophylactic interventions for future cancers that the patient may be at higher risk of developing. As germline mutations are heritable, this information provides the opportunity for early surveillance in the patients family members, as well.

TARGETED ONCOLOGY: Can you explain how this MSKCC study came about?

Ceyhan-Birsoy: Genetic testing for hereditary cancer predisposition is traditionally performed in a guideline-dependent and targeted manner. In current practice, only patients who meet established criteria from national and professional organizations receive genetic testing and typically get tested for a small number of genes selected based on their tumor type, age of onset, and family histories. MSKCC has been 1 of the first institutes to pilot a universal testing approach for cancer patients, providing comprehensive germline testing of all known cancer predisposition genes without pre-selection of patients based on traditional genetic testing criteria. We have been performing both targeted and universal testing for our patients since 2015.

In this study, we aimed to understand how the yields (positive rates) of these 2 testing approaches compare to each other in greater than 4000 patients who had traditional and more than 9,000 patients who had universal testing at MSKCC in the past 5 years. We also assessed whether universal testing identified additional findings that would have been missed in a targeted testing approach for any given patient.

TARGETED ONCOLOGY: What are the key results of this analysis?

Ceyhan-Birsoy: We saw that universal germline testing without preselection of patients based on current guidelines yielded comparable rates of positive results to traditional guideline-dependent testing approach, particularly in patients with breast, ovarian, and pancreatic cancers. In addition, universal testing uncovered mutations that predispose to other cancers in about 9% of patients in genes that are not routinely tested for their diagnosis. Approximately half of those conferred high to moderate risk to cancer and about 40% of them implicated early surveillance or prophylactic surgery recommendations to prevent other cancers.

TARGETED ONCOLOGY: What is a key takeaway from your AMP 2020 presentation and explain the implications of these findings?

Ceyhan-Birsoy: Our results suggest that the preselection of patients for genetic testing based on the current guidelines may not significantly increase the likelihood of identifying a germline mutation in certain patient populations. A universal and comprehensive testing approach further provides the benefit of identifying hereditary risk for other cancers, allowing early surveillance and prophylactic interventions.

TARGETED ONCOLOGY: How can this information be applied in oncology clinics?

Ceyhan-Birsoy: Our study underlies the advantages of universal and comprehensive testing for cancer patients. However, there are many challenges that may limit the application of this approach for all cancer patients, including the cost of testing, resources needed to provide pre-test and post-test genetic counseling to patients, and the potential to discover more variants of uncertain significance that may lead to higher number of inconclusive results. Future efforts should be dedicated to providing wider groups of cancer patients access to genetic testing, which can aid in their clinical care and in the care of their family members.

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Myriad Genetics Announces Global Expansion of Myriad myChoice Tumor Testing in Europe and China – GlobeNewswire

SALT LAKE CITY, Nov. 16, 2020 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (NASDAQ: MYGN), a global leader in molecular diagnostics and precision medicine, announced today the expansion of Myriad myChoice tumor testing in several European markets and China.

Myriad myChoice CDx is the industrys most clinically-validated genomic instability test. The test enables physicians to identify patients with tumors that have lost the ability to repair double-stranded DNA breaks, resulting in potentially increased susceptibility to DNA-damaging drugs such as platinum drugs or PARP inhibitors, including Lynparza (olaparib). A biomarker subgroup analysis of the PAOLA-1 Phase III trial (Olaparib plus Bevacizumab as First-Line Maintenance in Ovarian Cancer, 2019) of Lynparza included patients with advanced ovarian cancer and homologous recombination deficient (HRD)-positive tumors as detected by the myChoice test, including those with BRCA gene mutations. The trial showed that Lynparza in combination with bevacizumab maintenance treatment improved progression-free survival to a median of 37.2 months versus 17.7 months for bevacizumab alone in patients with HRD-positive advanced ovarian cancer. Recently, the European Commission authorized use of Lynparza for the first-line maintenance treatment with bevacizumab of patients with HRD-positive advanced ovarian cancer. Lynparza is jointly developed and commercialized by AstraZeneca (LSE/STO/Nasdaq: AZN) and Merck.

As part of the expansion in Europe, Myriad will license and provide technological support to leading pathology institutes in Germany and France. Additionally, Myriad will support European customers by performing testing out of its clinical laboratory at the companys global headquarters in Salt Lake City. Also, the institutes in Europe will perform the tests with Myriads myChoice CDx PLUS assay. Myriad myChoice CDx PLUS is CE-marked in accordance with the In-Vitro Diagnostic Devices Directive (98/79/EC).

Another collaboration in China provides that Myriad will partner with Burning Rock Biotech, a leader in next generation sequencing technology for precision oncology, to provide myChoice for HRD testing in Phase III clinical studies and clinics throughout China. Myriad will provide Burning Rock with access to its proprietary myChoice technology. The partnership with Burning Rock expands global access to myChoice and positions the test as a preferred developmental companion diagnostic in this important drug development category.

These new strategic partnerships with leading companies dedicated to advancing the power of precision medicine, reinforce Myriads commitment to expanding access to genetic insights for more patients than ever before, said Nicole Lambert, president of Myriad Genetic Laboratories. Through close collaboration with innovative laboratories in Europe and with Burning Rock in China, we are bringing the clinical benefits of myChoice testing to additional markets and patients, advancing personalized treatment for patients around the world.

In August 2020, myChoice was exclusively cited and the only named commercial companion diagnostic by the American Society of Clinical Oncology in new recommendations on the use of PARP inhibitors for the treatment and management of certain patients with advanced ovarian cancer. The new recommendations, based on clinical trial results, were published in the Journal of Clinical Oncology.

AboutMyriad myChoice Myriad myChoice is the most comprehensive homologous recombination deficiency (HRD) test, enabling physicians to identify patients with tumors that have lost the ability to repair double-stranded DNA breaks, resulting in increased susceptibility to DNA-damaging drugs such as platinum drugs or PARP inhibitors. The myChoice test comprises tumor sequencing of the BRCA1 and BRCA2 genes and a composite of three proprietary technologies (loss of heterozygosity, telomeric allelic imbalance and large-scale state transitions). For more information, visit: https://myriad-oncology.com/mychoice-cdx/

About Myriad Genetics Myriad Genetics Inc., is a leading personalized medicine company dedicated to being a trusted advisor transforming patient lives worldwide with pioneering molecular diagnostics. Myriad discovers and commercializes molecular diagnostic tests that: determine the risk of developing disease, accurately diagnose disease, assess the risk of disease progression, and guide treatment decisions across six major medical specialties where molecular diagnostics can significantly improve patient care and lower healthcare costs. Myriad is focused on three strategic imperatives: transitioning and expanding its hereditary cancer testing markets, diversifying its product portfolio through the introduction of new products and increasing the revenue contribution from international markets. For more information on how Myriad is making a difference, please visit the Company's website:www.myriad.com.

Myriad, the Myriad logo, BART, BRACAnalysis, Colaris, Colaris AP, myPath, myRisk, Myriad myRisk, myRisk Hereditary Cancer, myChoice, myPlan, BRACAnalysis CDx, Tumor BRACAnalysis CDx, myChoice CDx, Vectra, Prequel, Foresight, GeneSight, riskScore and Prolaris are trademarks or registered trademarks of Myriad Genetics, Inc. or its wholly owned subsidiaries in the United States and foreign countries. MYGN-F, MYGN-G.

Safe Harbor Statement This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements related to the Companys new international collaborations on the myChoice CDx test, including offering the test to European patients, and partnering with pathology institutes in Europe and Burning Rock in China; and the Companys strategic directives under the caption "About Myriad Genetics." These "forward-looking statements" are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by forward-looking statements. These risks and uncertainties include, but are not limited to: uncertainties associated with COVID-19, including its possible effects on our operations and the demand for our products and services; our ability to efficiently and flexibly manage our business amid uncertainties related to COVID-19; the risk that sales and profit margins of our molecular diagnostic tests and pharmaceutical and clinical services may decline; risks related to our ability to transition from our existing product portfolio to our new tests, including unexpected costs and delays; risks related to decisions or changes in governmental or private insurers reimbursement levels for our tests or our ability to obtain reimbursement for our new tests at comparable levels to our existing tests; risks related to increased competition and the development of new competing tests and services; the risk that we may be unable to develop or achieve commercial success for additional molecular diagnostic tests and pharmaceutical and clinical services in a timely manner, or at all; the risk that we may not successfully develop new markets for our molecular diagnostic tests and pharmaceutical and clinical services, including our ability to successfully generate revenue outside the United States; the risk that licenses to the technology underlying our molecular diagnostic tests and pharmaceutical and clinical services and any future tests and services are terminated or cannot be maintained on satisfactory terms; risks related to delays or other problems with operating our laboratory testing facilities and our healthcare clinic; risks related to public concern over genetic testing in general or our tests in particular; risks related to regulatory requirements or enforcement in the United States and foreign countries and changes in the structure of the healthcare system or healthcare payment systems; risks related to our ability to obtain new corporate collaborations or licenses and acquire new technologies or businesses on satisfactory terms, if at all; risks related to our ability to successfully integrate and derive benefits from any technologies or businesses that we license or acquire; risks related to our projections about our business, results of operations and financial condition; risks related to the potential market opportunity for our products and services; the risk that we or our licensors may be unable to protect or that third parties will infringe the proprietary technologies underlying our tests; the risk of patent-infringement claims or challenges to the validity of our patents or other intellectual property; risks related to changes in intellectual property laws covering our molecular diagnostic tests and pharmaceutical and clinical services and patents or enforcement in the United States and foreign countries, such as the Supreme Court decisions in Mayo Collab. Servs. v. Prometheus Labs., Inc., 566 U.S. 66 (2012), Assn for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013), and Alice Corp. v. CLS Bank Intl, 573 U.S. 208 (2014); risks of new, changing and competitive technologies and regulations in the United States and internationally; the risk that we may be unable to comply with financial operating covenants under our credit or lending agreements; the risk that we will be unable to pay, when due, amounts due under our credit or lending agreements; and other factors discussed under the heading "Risk Factors" contained in Item 1A of our most recent Annual Report on Form 10-K for the fiscal year ended June 30, 2020, which has been filed with the Securities and Exchange Commission, as well as any updates to those risk factors filed from time to time in our Quarterly Reports on Form 10-Q or Current Reports on Form 8-K. All information in this press release is as of the date of the release, and Myriad undertakes no duty to update this information unless required by law.

Media Contact: Jared Maxwell (801) 505-5027 jmaxwell@myriad.comInvestor Contact: Scott Gleason(801) 584-1143sgleason@myriad.com

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