Myriad's myRisk® Hereditary Cancer Test Finds More Than 12 Percent of Men with Prostate Cancer Carry an Inherited Genetic Mutation

February 7, 2018 at 7:05 AM EST

SALT LAKE CITY, Feb. 07, 2018 (GLOBE NEWSWIRE) --

Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, announced today that results from a large 1,162 patient study of the Myriad myRisk® Hereditary Cancer test will be featured during the poster presentation at the 2018 Genitourinary Cancer Symposium in San Francisco, Calif.  The key finding is that more than 12 percent of men with prostate cancer had an inherited (i.e. hereditary) mutation in a cancer-causing gene.

"As one of the largest studies of hereditary cancer risk assessment ever conducted in prostate cancer, our myRisk Hereditary Cancer test demonstrated that roughly the same percentage of men with prostate cancer carry hereditary cancer-causing mutations as do women with breast cancer," said Johnathan Lancaster, M.D., Ph.D., chief medical officer, Myriad Genetics.  "These compelling findings provide a strong reason for expanding the use of genetic testing in men diagnosed with prostate cancer consistent with existing professional medical guidelines."

The key data are summarized below and the abstract is available at: abstracts.asco.org.  Follow Myriad on Twitter via @MyriadGenetics and stay informed about symposium news and updates by using the hashtag #GU18.

Title:  Inherited Germline Mutations in Men with Prostate Cancer.
Presenter:  Robert Reid, M.D., Virginia Cancer Specialists.
Date:  Sunday, February 9, 2018, 12:15 — 1:45 p.m. and 6:00 p.m. — 7:00 p.m.   
Location:  Poster Board E4; Poster Abstract 357.

The study will be presented by Robert Reid, M.D. from the Virginia Cancer Specialists who served as the lead investigator of this study.  The study objective was to evaluate genetic testing using the 28-gene myRisk Hereditary Cancer test in 1,162 men with a personal history of prostate cancer.  Of these, 64 percent had a history of prostate cancer, while 36 percent had a history of prostate cancer and at least one additional cancer.  The results showed that 12.1 percent of men with prostate cancer were positive for one or more hereditary cancer mutations in the genes tested.  Additionally, the positive rate was significantly higher among men with prostate cancer plus one other cancer (14.7 percent).  The inherited mutations were found in genes with a well-known prostate cancer risk (i.e., BRCA2) as well as genes historically associated with other cancer types including breast and colon.  These findings suggest that hereditary cancer testing in men with prostate cancer may aid in medical management decision making to reduce overall cancer risk.

"We believe hereditary cancer testing can help inform treatment decisions for these men, including whether to pursue active surveillance, increased screening for secondary cancers and potentially for treatment selection with PARP inhibitors or other medicines in the future," said Dr. Lancaster.  "Additionally, once men know they carry an inherited mutation, they can encourage their family members to get tested to learn if they're at increased risk for cancer and potentially help them prevent future cancers."

The National Comprehensive Cancer Network, American Urological Association (AUA) and an academic consensus panel all support hereditary cancer risk assessment for patients with prostate cancer deemed to be high risk due to metastatic disease or high grade cancer with a family history of BRCA associated cancers including breast, ovarian, pancreatic or prostate cancer.

Importantly, the AUA position states that: "Patients with localized prostate cancer who are at highest risk for developing metastatic castration-resistant prostate cancer, may have a higher incidence of germline DNA repair mutations than expected from published reports. The presence of germline DNA repair gene mutations has important implications for the prostate cancer patient in terms of general cancer screening and possible future prostate cancer treatment decisions. Additionally the presence of germline DNA repair mutations is of utmost relevance to the patient's first-degree family members due to increased cancer risk and screening implications."

About Prostate Cancer
One in nine American men will have prostate cancer during his lifetime. Prostate cancer is the second leading cause of cancer death among American men and is the most commonly diagnosed.  The American Cancer Society estimates in its Cancer Facts & Figures 2018 report that 164,690 men will be told they have prostate cancer in 2018.  Currently, there are nearly 2.9 million American men living with the disease and every 18 minutes another American man dies from prostate cancer. That's a little more than 80 deaths per day and 29,430 this year.

About Myriad myRisk® Hereditary Cancer
The Myriad myRisk Hereditary Cancer test uses an extensive number of sophisticated technologies and proprietary algorithms to evaluate 28 clinically significant genes associated with eight hereditary cancer sites including: breast, colon, ovarian, endometrial, pancreatic, prostate and gastric cancers and melanoma.  The myRisk Hereditary Cancer test offers physicians several distinct advantages over other commercial tests, including unsurpassed lab accuracy, industry leading variant classification and exceptional customer service.

Men with prostate cancer can take the Hereditary Cancer Quiz to find out if they might be at risk for an inherited mutation and qualify for myRisk Hereditary Cancer test.

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 five strategic imperatives:  build upon a solid hereditary cancer foundation, growing new product volume, expanding reimbursement coverage for new products, increasing RNA kit revenue internationally and improving profitability with Elevate 2020.  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 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 results from a large 1,162 patient study of the Myriad myRisk® Hereditary Cancer test being featured during the poster presentation at the 2018 Genitourinary Cancer Symposium in San Francisco; the study findings providing a strong reason for expanding the use of genetic testing in men diagnosed with prostate cancer consistent with existing professional medical guidelines; the study being presented by Robert Reid, M.D. from the Virginia Cancer Specialists; hereditary cancer testing in men with prostate cancer aiding in medical management decision making to reduce overall cancer risk; hereditary cancer testing helping inform treatment decisions for these men, including whether to pursue active surveillance, increased screening for secondary cancers and potentially for treatment selection with PARP inhibitors or other medicines in the future; knowledge that they carry an inherited mutation potentially helping them and their families prevent future cancers; and the Company's strategic directives under the captions "About BRACAnalysis CDx," and "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, 2016, 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:       Ron Rogers
(908) 285-0248
rrogers@myriad.com
                             Investor Contact:       Scott Gleason
(801) 584-1143
sgleason@myriad.com