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NCCN Guidelines Broadly Endorse Biomarker Testing in Prostate Cancer

Prolaris®, myRisk® Hereditary Cancer, and myChoice® HRD Testing Are Appropriate For a Total of 200,000 Prostate Cancer Patients per Year

/EIN News/ -- SALT LAKE CITY, Feb. 20, 2018 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (NASDAQ:MYGN) today announced that the National Comprehensive Cancer Network (NCCN) has updated its medical guidelines for prostate cancer treatment to broadly include biomarker testing in prostate cancer. The changes to the guidelines include new language supporting Prolaris® as standard of care in treatment decision making for patients with low and favorable-intermediate risk prostate cancer. Additionally, the new guidelines support an expansion of hereditary cancer testing for prostate cancer to include all patients with a family history regardless of Gleason score along with all patients with metastatic disease, and new recommendations supporting testing for homologous recombination deficiency (HRD) in patients with metastatic prostate cancer.

“We view this significant update in guidelines as a clear indication of the increasing importance of molecular biomarkers in guiding prostate cancer care and Myriad is uniquely positioned with its broad portfolio of tests to address these clinical needs,” said Nicole Lambert, general manager, Urology. “These new guidelines are critical in our efforts to broaden insurance coverage and increase patient access to Myriad’s entire portfolio of prostate cancer molecular diagnostic tests.”

Below are the key updates from the guidelines:

  • Prolaris: now standard of care for 110,000 patients per year identified as low or favorable-intermediate risk patients.
  • myRisk Hereditary Cancer: now recommended for approximately 70,000 prostate cancer patients per year including all patients with metastatic prostate cancer and those with a family history of cancer regardless of Gleason score.
  • myChoice HRD: now recommended for 20,000 patients per year with metastatic prostate cancer to identify tumors with homologous recombination deficiency (HRD) so that these patients can be considered for targeted therapies. 

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 patients with prostate cancer. 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 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 the development of eight hereditary cancers 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, a medical management tool 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 therefore eligible for myRisk Hereditary Cancer test.

About myChoice® HRD
Myriad's myChoice HRD is the most comprehensive homologous recombination deficiency test, enabling physicians to identify tumors that have lost the ability to repair double-stranded DNA breaks, resulting in increased susceptibility to DNA-damaging drugs such as platinum drugs or PARP inhibitors. The myChoice HRD test is a composite of three proprietary technologies (loss of heterozygosity, telomeric allelic imbalance and large-scale state transitions).

Positive myChoice HRD scores, reflective of DNA repair deficiencies, are prevalent in all breast cancer subtypes, ovarian cancer and most other major cancers. It is estimated that 1.4 million people in the United States and Europe who are diagnosed with cancers annually may be candidates for treatment with DNA-damaging agents. Learn more: https://mychoicehrd.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 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 relating to the new guidelines supporting an expansion of hereditary cancer testing for prostate cancer to include all patients with a family history regardless of Gleason score along with all metastatic patients; the increasing importance of molecular biomarkers in guiding prostate cancer care and the Company being uniquely positioned with its broad portfolio of tests to address these clinical needs; the Company’s efforts to broaden insurance coverage and increase patient access to the Company’s entire portfolio of prostate cancer molecular markers; the anticipated number of prostate cancer patients now indicated for Prolaris®, myRisk® Hereditary Cancer, and myChoice® HRD testing under the new NCCN guidelines; 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             
(801) 584-3065        
rrogers@myriad.com

Investor Contact:
Scott Gleason
(801) 584-1143
sgleason@myriad.com

 

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