News | August 2, 2021

Myriad Genetics Expands Access To Genetic Testing With Launch Of First Polygenic Breast Cancer Risk Assessment Score Validated For Women Of All Ancestries

  • Myriad’s MyRisk® Hereditary Cancer test with RiskScore® provides a breast cancer risk assessment for all women not previously diagnosed with breast cancer, regardless of ancestry
  • MyRisk with RiskScore is an important step to help address racial and ethnic disparities in the healthcare system

​Salt Lake City, UT, (GLOBE NEWSWIRE) - Advancing its mission to expand access to genetic testing, Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in genetic testing and precision medicine, today launched a new version of its market-leading MyRisk Hereditary Cancer Test. For the first time, women of all ancestries can now receive a personalized polygenic breast cancer risk assessment together with the market’s most accurate hereditary cancer test.

MyRisk with RiskScore offers a breast cancer risk assessment designed to improve patient outcomes and help minimize healthcare disparities. RiskScore results are informed by a combination of genetic markers, clinical and biological variables, personal and family history, and ancestry-specific data. RiskScore is available at no additional cost to women who take the MyRisk test.

With traditional hereditary cancer tests, approximately 95% of women will test negative for high-risk gene mutations, but still have additional breast cancer risk factors that need to be managed. The RiskScore component of MyRisk helps women and their physicians assess those added risk factors. An estimated 56% of patients who undergo MyRisk testing and receive a RiskScore result, qualify for medical management changes such as increased cancer surveillance or intervention.

Working with industry leading researchers, Myriad Genetics assessed data from more than 275,000 women to validate the use of an enhanced method for assessing polygenic breast cancer risk assessments like RiskScore in women across ancestries. The research was presented by Dr. Holly Pederson, director of Medical Breast Services at Cleveland Clinic, at the 2021 American Society of Clinical Oncology (ASCO) annual meeting.

“The polygenic risk score (PRS) is one of the most powerful risk prediction tools in the field of breast cancer, and until now a validated model had not been available to assess women of all ancestries,” said Pederson. “Our data now provide a framework for a PRS that delivers a personalized genomic breast cancer risk assessment to any and all interested women. The updated PRS, validated and well-calibrated, may be the most exciting clinical development in risk stratification since multi-gene panel testing.”

Since 2017, Myriad’s MyRisk test has included a polygenic breast cancer risk assessment (RiskScore) for women who test negative for gene mutations known to put them at risk for several cancers. The assessment provides women with a clinically validated, five-year and remaining lifetime breast cancer risk calculation. Women who previously took the MyRisk test since 2017 and were unable to benefit from RiskScore due to genetic ancestry, will now be offered the opportunity to have their risk assessment updated by Myriad Genetics free of charge.

“I am proud of Myriad’s commitment and investment in innovation that serves our patients of all ancestries,” said Nicole Lambert, president of Myriad Genetic Laboratories. “All women deserve to know their precise risk to develop breast cancer and the power to choose how to manage that risk.”

“All women in the U.S. should have equal access to the insights that genetic testing provides,” said Dr. Monique Gary, DO, FACS, breast surgeon and patient advocate at Grand View Health in Sellersville, PA. “As a doctor, improving health outcomes has always been my mission. Women and the physicians whom they trust for guidance will now have access to an assessment tool that considers the unique genetic makeup of different ethnicities, providing vital information that can help save lives.”

About Myriad MyRisk with RiskScore
The MyRisk Hereditary Cancer Test uses advanced technologies and proprietary algorithms to evaluate 35 clinically significant genes associated with eight hereditary cancer sites including breast, colon, ovarian, endometrial, pancreatic, prostate, gastric cancers, and melanoma. RiskScore for all ancestries is a precision medicine tool that enhances the Myriad MyRisk test. The assessment incorporates data from more than 140 single nucleotide polymorphisms identified through 20 years of genome-wide association studies in breast cancer and ancestral studies.

About Myriad Genetics
Myriad Genetics is a leading genetic testing and precision medicine company dedicated to advancing health and wellbeing for all, empowering individuals with vital genetic insights and enabling healthcare providers to better detect, treat and prevent disease. Myriad discovers and commercializes genetic tests that determine the risk of developing disease, assess the risk of disease progression, and guide treatment decisions across medical specialties where critical genetic insights can significantly improve patient care and lower healthcare costs. For more information, visit the company's website: www.myriad.com.

Myriad, the Myriad logo, BART, BRACAnalysis, Colaris, Colaris AP, myRisk, Myriad myRisk, myRisk Hereditary Cancer, myChoice, myPlan, BRACAnalysis CDx, Tumor BRACAnalysis CDx, myChoice CDx, Vectra, EndoPredict, 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.

Safe Harbor Statement
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to receiving a personalized breast cancer risk assessment for women of all ancestries, patients who undergo MyRisk testing and receive a RiskScore result, the utility of the RiskScore component of MyRisk and the company’s 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; risks related to our ability to efficiently and flexibly manage our business amid uncertainties associated with COVID-19; the risk that sales and profit margins of our existing molecular diagnostic tests may decline or that we may not be able to operate our business on a profitable basis; risks related to our ability to generate sufficient revenue from our existing product portfolio or in launching and commercializing new tests; risks related to changes in governmental or private insurers’ coverage and 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 in a timely manner, or at all; the risk that we may not successfully develop new markets for our molecular diagnostic tests, including our ability to successfully generate revenue outside the United States; the risk that licenses to the technology underlying our molecular diagnostic tests and any future tests are terminated or cannot be maintained on satisfactory terms; risks related to delays or other problems with operating our laboratory testing facilities; 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 the potential market opportunity for our products; 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 patents or enforcement in the United States and foreign countries; 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; risks related to the material weakness identified in our internal control over financial reporting, including the impact thereof and our remediation plan; and other factors discussed under the heading "Risk Factors" contained in Item 1A of our Transition Report on Form 10-K for the six month transition period ended December 31, 2020, which was filed with the Securities and Exchange Commission on March 16, 2021, 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.

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Source: Myriad Genetics, Inc.