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Myriad Announces Inclusion of Prolaris(R) Test in NCCN Guidelines

SALT LAKE CITY, Oct. 27, 2014 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (Nasdaq:MYGN) today announced that its Prolaris test has been included in the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology (NCCN Guidelines) for all men with localized prostate cancer, regardless of their risk category. The NCCN guidelines provide treatment recommendations to ensure that patients receive diagnostic treatment and services that are likely to improve clinical outcomes.

Specifically, the updated NCCN guidelines include the use of the Prolaris test to help patients better assess their risk of disease specific mortality and biochemical recurrence. Importantly, Prolaris is supported by seven peer-reviewed publications and is the first and only genetic test for prostate cancer that is:

  • Proven and validated based on gold standard clinical endpoints of disease recurrence and prostate cancer-specific death in untreated men, thus identifying men who can safely forgo initial surgery or radiation and be managed with active surveillance;
  • Proven in clinical utility studies to change treatment recommendations for up to 65 percent of prostate cancer patients in all risk categories, which may enhance adherence to recommended treatments; and
  • To receive a draft local coverage determination (LCD) for Medicare reimbursement for low-risk patients.

"We are excited that the NCCN has included Prolaris as an important prognostic test to help inform men with localized prostate cancer about the aggressiveness of their disease and to help their physicians tailor therapy based on a more accurate assessment of risk," said Chip Parkinson, general manager of the Urology Business Unit at Myriad. "Prolaris is the only test proven to accurately predict mortality in men with localized prostate cancer, and the only biomarker validated in studies of patients who were untreated. This means that men can be confident in choosing active surveillance with Prolaris."

Earlier this month, Myriad announced that Palmetto GBA, the Medicare administrative contractor, issued a draft LCD for the Prolaris test for patients with low-risk prostate cancer. Once finalized, the LCD will establish coverage policy for Medicare beneficiaries throughout the United States.

About Prolaris®

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

About Myriad Genetics

Myriad Genetics is a leading molecular diagnostic company dedicated to making a difference in patients' lives through the discovery and commercialization of transformative tests to assess a person's risk of developing disease, guide treatment decisions and assess risk of disease progression and recurrence. Myriad's molecular diagnostic tests are based on an understanding of the role genes play in human disease and were developed with a commitment to improving an individual's decision making process for monitoring and treating disease. Myriad is focused on strategic directives to introduce new products, including companion diagnostics, as well as expanding internationally. For more information on how Myriad is making a difference, please visit the Company's websites: www.myriad.com.

Myriad, the Myriad logo, BART, BRACAnalysis, Colaris, Colaris AP, myPath, myRisk, myRisk Hereditary Cancer, myChoice, myPlan Lung Cancer, BRACAnalysis CDx, HRD, Vectra and Prolaris are trademarks or registered trademarks of Myriad Genetics, Inc. 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 relating to the inclusion of the Prolaris test in the NCCN guidelines for all men with localized prostate cancer, regardless of their risk category; the NCCN guidelines providing treatment recommendations to ensure that patients receive diagnostic treatment and services that are likely to improve clinical outcomes; the use of the Prolaris test to help patients and their physicians better assess their risk of disease specific mortality and biochemical recurrence; the ability of the Prolaris test to predict prostate cancer-specific disease progression; the ability of the Prolaris test to identify men who can safely forgo initial surgery or radiation and be managed with active surveillance; the ability of the Prolaris test to change treatment recommendations for up to 65 percent of prostate cancer patients in all risk categories, which may enhance adherence to recommended treatments; the CMS draft local coverage determination for the Prolaris test, and the scope, timing and effectiveness of a final local coverage determination; the Prolaris testing being the only test to accurately predict clinical outcomes or influence treatment plans for patients; 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 existing molecular diagnostic tests and pharmaceutical and clinical services may decline or will not continue to increase at historical rates; risks related to our ability to transition from our existing product portfolio to our new tests; risks related to changes in the 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 we may not be successful in transitioning from our existing product portfolio to our new products, such as our myRisk Hereditary Cancer test, which represents the next generation of our existing hereditary cancer franchise; the risk that we may not be able to generate sufficient revenue from our existing tests and our new tests or develop new tests; the risk that licenses to the technology underlying our molecular diagnostic tests and pharmaceutical and clinical services and any future tests are terminated or cannot be maintained on satisfactory terms; risks related to delays or other problems with manufacturing our products or operating our laboratory testing facilities; 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 increased competition and the development of new competing tests and services; risks related to our projections about the potential market opportunity for our products; 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; 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 in our most recent Annual Report on Form 10-K 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.

CONTACT: Media Contact: Ron Rogers (801) 584-3065 rrogers@myriad.com Investor Contact: Scott Gleason (801) 584-1143 sgleason@myriad.com

Source:Myriad Genetics, Inc.