Myriad Genetics Announces New Results from Two Large Studies of Its myRisk® Hereditary Cancer Test at American Society of Clinical Oncology

SALT LAKE CITY, June 03, 2019 (GLOBE NEWSWIRE) — Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in molecular diagnostics and personalized medicine, announced today that results from two studies of the myRisk^® Hereditary Cancer test will be featured today in presentations at the annual meeting of the American Society of Clinical Oncology (ASCO).

The key findings were that women with post-menopausal breast cancer had a high rate of inherited mutations in a range of cancer causing genes, and that overall this mutation rate did not diminish with age.  In a separate study, panel testing did not appear to result in over-use of preventative surgery.  The findings will be presented by research collaborators from Stanford University Cancer Institute and the University of Southern California (USC) Norris Comprehensive Cancer Center.

“We thank our research partners for their outstanding collaboration, and are excited to share new information that advances the field of personalized medicine for people with or at risk for breast cancer,” said Johnathan Lancaster, M.D., Ph.D., chief medical officer, Myriad Genetics, Inc.  “As scientific evidence continues to mount, we have entered an era when all women diagnosed with breast cancer should be considered for genetic testing.”

Summaries of the studies appear below and abstracts are available at https://abstracts.asco.org.  Please visit Myriad Genetics at booth #5087 to learn more about our leading portfolio of personalized medicine products.  Follow Myriad on Twitter via @myriadgenetics and keep up to date with ASCO meeting news and updates by using the hashtag #ASCO19.

myRisk Hereditary Cancer Poster Presentations
Title:  Prevalence and penetrance of inherited pathogenic variants in breast cancer susceptibility genes in the Women’s Health Initiative.
Presenter:  Allison Kurian, M.D., Stanford University Cancer Institute.
Date:  Monday, June 3, 2019, 1:15 – 4:15 p.m.
Location:  Poster 1513

This Women’s Health Initiative ancillary study (AS508) used the myRisk Hereditary Cancer test to evaluate the prevalence and penetrance of pathogenic variants across 28 genes in 2,195 post-menopausal women with breast cancer compared to 2,322 post-menopausal women without breast cancer.  The study demonstrated that approximately seven percent of patients with breast cancer tested positive for a pathogenic variant.  Importantly, these mutations were in genes of high penetrance (BRCA1/2, OR = 5; BARD1, OR=10; PALB2, OR=6; other breast cancer genes, OR=2), and the mutation rate in non-BRCA1/2 genes did not diminish with age.

“Approximately 80 percent of breast cancers occur in postmenopausal women, and this study shows that many of these women carry harmful mutations in high penetrance breast cancer genes,” said Dr. Lancaster.  “These findings reinforce the importance of expanded access to broader genetic testing for women with breast cancer.”

Title:  Preventive surgery after multiplex genetic panel testing.
Presenter:  Gregory Idos, M.D., USC Norris Comprehensive Cancer Center.
Date:  Monday, June 3, 2019, 1:15 – 4:15 p.m.
Location:  Poster 1525.

This study evaluated surgery utilization in a prospective, multi-institutional cohort of 1,537 women who received multiplex genetic panel testing with the myRisk Hereditary Cancer test. Overall, 12.9 percent of patients reported surgery after testing. Preventive surgery utilization was statistically significantly higher among patients who tested positive for a pathogenic mutation compared to those testing negative or with a VUS (p<0.001).  Preventive surgery was very low among patients testing negative or VUS who had no personal history of cancer.

“This study found that patients with a clinically-actionable genetic mutation and/or personal history of cancer were most likely to receive surgery, while those with a VUS or negative result and no cancer history were least likely to undergo surgery,” said Dr. Lancaster.  “Importantly, this study demonstrates that surgery was not over-utilized following genetic panel testing.”

About Myriad myRisk^® Hereditary Cancer
The Myriad myRisk Hereditary Cancer test uses an extensive number of sophisticated technologies and proprietary algorithms to evaluate 35 clinically significant genes associated with eight hereditary cancer sites including: breast, colon, ovarian, endometrial, pancreatic, prostate and gastric cancers and melanoma.

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 HRD, EndoPredict, Vectra, GeneSight, riskScore Prolaris, ForeSight and Prequel 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 presentation of data from two clinical studies at the 2019 American Society of Clinical Oncology annual meeting to be held May 31 to June 4, 2019 in Chicago, Ill; key podium presentations highlighting the performance of the myRisk hereditary multigene panel test in assessing hereditary cancer risk; the myRisk Hereditary Cancer studies presented at ASCO advancing the field of hereditary cancer testing; the new data providing additional evidence for the safety and efficacy of the myRisk Hereditary Cancer test to help improve and save the lives of patients; many post-menopausal women carrying harmful mutations in high penetrance breast cancer genes; entering an era when all women diagnosed with breast cancer should be considered for genetic testing; these study findings reinforcing the importance of expanded access to broader genetic testing for women and breast cancer; 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: 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 decision in the lawsuit brought against us by the Association for Molecular Pathology et al; risks of new, changing and competitive technologies and regulations in the United States and internationally; 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, 2018, 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.