Myriad Genetics Advances Prostate And Renal Cancer Molecular Diagnostic Tests At The 2016 ASCO Genitourinary Cancers Symposium

SALT LAKE CITY, Jan. 07, 2016 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, today announced that new data will be highlighted on prostate and renal cancers at the 2016 ASCO Genitourinary Cancers Symposium, January 7-9, in San Francisco, Calif. These presentations reaffirm the Company’s commitment to developing pioneering molecular diagnostics in the fight against urological cancers.

"We are committed to continuing our pioneering work in urology," said Dr. Michael Brawer, M.D., senior vice president of Medical Affairs, Myriad Genetic Laboratories. "Urologic cancers claim thousands of lives every year and are a leading cause of disability. Myriad developed Prolaris, the first prostate cancer prognostic test, and is bringing that same level of rigorous scientific innovation to renal cancer prognosis as well. We remain dedicated to developing new biomarker-based diagnostics to combat urologic diseases and improve patient care."

The following key studies will be presented by collaborators during the ASCO GU symposium.

Highlighted Presentations

  • Title: Application of Active Surveillance Threshold to Series of Samples Submitted for Commercial Testing.
    Date: Thursday, January 7, 2016: 11:30 a.m.–1:00 p.m. PT.
    Location: Poster Session A.
    Presenter: Daniel Lin, M.D., University of Washington.

    In this study 11,665 men diagnosed with prostate cancer were evaluated to determine which patients would be candidates for active surveillance (AS) based on their combined clinical risk (CCR) score. CCR is a composite of the Prolaris® test with clinical features measured by CAPRA (Cancer of the Prostate Risk Assessment). The results showed that 7,325 men (63 percent) qualified for AS based on their CCR score. Of these, a substantial number of patients, 3,306 (45 percent), would not have qualified for AS based on their clinical features alone. Therefore, for patients considering deferred treatment, the Prolaris test provides significant prognostic information at the time of diagnosis beyond traditional pathological measures of risk.

  • Title: Prognostic Utility of a Multi-Gene Signature (the Cell Cycle Proliferation Score) in Patients with Renal Cell Carcinoma after Radical Nephrectomy.
    Date: Saturday, January 9, 2016: 11:30 a.m.–1:00 p.m. PT.
    Location: Poster Session C.
    Presenter: Todd Morgan, M.D., University of Michigan.

    This study assessed the ability of the myPlan® Renal Cancer test to predict disease recurrence or disease-specific mortality in 305 patients who had a radical nephrectomy. The results demonstrate that myPlan Renal Cancer is a significant predictor of key long-term oncologic outcomes in patients who have undergone a radical nephrectomy for renal cancer, providing information beyond what is available from clinical parameters alone. When the myPlan score is combined with pathological stage to provide a composite prognostic score (PS), patients with a high PS had a three-fold increased risk of recurrence compared to patients with a low score. These finding suggest that the myPlan Renal Cancer score may be useful in the clinical management of patients with renal cancer.

For more information about these presentations, please visit the ASCO GU website at http://gucasym.org/. Follow Myriad on Twitter via @MyriadGenetics and stay informed about news and updates by using the hashtag #GU16.

About Prolaris ®

Prolaris is a novel 46-gene RNA-expression test that directly measures tumor cell growth characteristics for stratifying the risk of disease-specific mortality in prostate cancer patients. Prolaris provides a quantitative measure of the RNA expression levels of genes involved in the progression of tumor growth. Low gene expression is associated with a low risk of disease-specific mortality in men who may be candidates for active surveillance and high gene expression is associated with a higher risk of disease-specific mortality in patients who may benefit from additional therapy. For more information visit: www.prolaris.com.

About Myriad myPlan® Renal Cancer

Myriad myPlan Renal Cancer is a molecular prognostic test that measures the expression levels of cell cycle progression genes to provide an accurate assessment of cancer aggressiveness in patients with renal cell carcinoma. For more information visit: https://www.myriad.com/.

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, 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 Company’s commitment to developing pioneering molecular diagnostics in the fight against urological disease; data on renal and prostate cancer being presented at this year’s 2016 ASCO Genitourinary Cancers Symposium; the ability of Prolaris to provide significant prognostic information at the time of disease diagnosis; the utility of the myPlan Renal Cancer test in the clinical management of patients with renal 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.

Media Contact: Ron Rogers (908) 285-0248 rrogers@myriad.com Investor Contact: Scott Gleason (801) 584-1143 sgleason@myriad.com

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