Myriad myRisk® Hereditary Cancer Article in Journal of Clinical Oncology Highlights Importance of Expanding Genetic Testing for Breast Cancer Patients

Prospective Clinical Study Showed the myRisk Test Identified 70 Percent More Deleterious Mutations than BRCA Testing Alone with 42 Percent of These in Women Over Age 45


SALT LAKE CITY, March 30, 2016 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, working in collaboration with researchers from the Harvard Medical School, today announced that the Journal of Clinical Oncology has published a paper showing the frequency of germline mutations in 25 cancer susceptibility genes among patients with breast cancer.  

“This is the first study to show the frequency of germline mutations in BRCA1/2 and other breast cancer predisposition genes in a sequential series of breast cancer patients prospectively collected and unselected for family history or age,” said Anne-Renee Hartman, M.D., an author of the publication and senior vice president of clinical development at Myriad Genetic Laboratories.  "Overall, the 25-gene panel identified 70 percent more breast cancer causing mutations than BRCA1/2 testing alone.  This important new finding is being used to identify more patients with mutations with the ultimate goal of helping them and their families to take appropriate risk reduction measures."

In this study, 488 patients newly diagnosed with breast cancer at the Dana-Farber Cancer Institute were evaluated for mutations in 25 cancer genes using the Myriad myRisk® Hereditary Cancer test.  The results show that 52 patients, or 10 percent, had a germline mutation in a breast cancer predisposition gene.  Approximately 30 mutations were in BRCA1/2 genes and 21 were in other cancer genes, representing a 70 percent increase in mutations identified above BRCA testing alone.  Importantly, of the women with deleterious mutations 22, or 42 percent, were diagnosed after age 45, suggesting that older patients may benefit from genetic testing using the 25-gene panel. 

“We are delighted to have partnered with Myriad to examine this important question,” said Judy E. Garber, M.D., director, Center for Cancer Genetics and Prevention, Dana-Farber Cancer Institute, and one of the lead investigators in the study.  “It is clear that panel testing is providing new information on inherited breast cancer predisposition, and we hope this study provides another piece of the puzzle.”

The online JCO publication can be accessed at: http://bit.ly/1Z6rLEj. Follow Myriad on Twitter via @MyriadGenetics to stay informed about news and updates from the Company.

About Myriad myRisk® Hereditary Cancer Testing
The Myriad myRisk Hereditary Cancer test uses an extensive number of sophisticated technologies and proprietary algorithms in an 850 step laboratory process to evaluate 25 clinically significant genes associated with eight hereditary cancer sites including: breast, colon, ovarian, endometrial, pancreatic, prostate and gastric cancers and melanoma.  For more information visit: https://www.myriad.com/products-services/hereditary-cancers/myrisk-hereditary-cancer/.

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, Vectra 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 clinical utility of the Myriad myRisk® Hereditary cancer gene panel test; multi-gene panel testing with Myriad myRisk Hereditary Cancer providing clinically significant results that drive appropriate changes in patient care; new data demonstrating positive perceptions from patients after they receive a multi-gene test result; the ability of the myRisk Hereditary Cancer test to identify a subset of patients with deleterious mutations who historically would have been missed by traditional genetic testing for BRCA1/2 genes alone, and who could receive appropriate medical management as a result; the findings of the studies suggesting that patients diagnosed with breast cancer at older ages may benefit from genetic testing with the Myriad myRisk Hereditary Cancer gene panel test; the Company’s commitment to bringing transformative molecular diagnostics to people with 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, 2015, 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.


            

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