Benzinga | Aug 2, 2021 07:12AM EDT

Myriad Genetics Expands Access to Genetic Testing with Launch of First Polygenic Breast Cancer Risk Assessment Score Validated for Women of All Ancestries

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."