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Press Release: New Study Demonstrates the Ability of Prolaris® to Predict Which Men With Prostate Cancer Will Benefit from Multi-Modality Therapy


SALT LAKE CITY, Feb. 14, 2020 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in molecular diagnostics and precision medicine, announced that it is presenting new data at the American Society of Clinical Oncology Genitouranary Cancer Symposium in San Francisco, California. The key finding is that Prolaris accurately predicts which men with intermediate or high-risk prostate cancer will benefit from multi-modality therapy and which can avoid unnecessary treatment.

“While it has been demonstrated that multi-modality therapy can improve overall survival in prostate cancer, it comes at the risk of increased morbidity and increased cost to the healthcare system,” said Jonathan Tward M.D., PhD, associate professor in the Department of Radiation Oncology at the University of Utah. “Prolaris provides a unique tool that can accurately predict which patients with high-risk prostate cancer will truly benefit from multi-modality therapy and conversely which patients with lower risk can safely avoid such treatments.”

The investigators evaluated 718 men with intermediate or high-risk prostate cancer. The Prolaris score predicted metastasis (HR=3.75; p=1.6x10-16) and remained highly predictive after adjusting for the effect of standard clinical and pathological features (HR=4.30; p=4.4x10-8). In the study, patients above the high-risk threshold with a Prolaris score of greater than 2.112, which comprised approximately 44 percent of the men in the study, saw a statistically significant benefit from multi-modality therapy leading to a reduction in risk of metastases. Patients below the high-risk threshold saw no benefit from multi-modality therapy, suggesting that such patients may be able to avoid additional morbidity associated with additional treatment.

About Prolaris®
Prolaris is a genetic test developed by Myriad that directly measures tumor cell growth. The Prolaris test paired with both prostate-specific antigen (PSA) and Gleason provides the level of aggressiveness of a patient’s individual prostate cancer. PSA and Gleason only have the ability to identify how far the cancer has progressed thus far. However, when these are combined with a Prolaris test score, patients get an accurate assessment of how aggressively that cancer will progress over the next ten years. For more information visit: www.prolaris.com

About Myriad Genetics
Myriad Genetics Inc. is a leading precision 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 critical success factors: building 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 CDx, EndoPredict, Vectra, GeneSight, riskScore, Prolaris, Foresight and Prequel 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.

Lynparza is a registered trademark of AstraZeneca.

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 Company presenting new data at the American Society of Clinical Oncology Genitouranary Cancer Symposium in San Francisco, California; patients below the high-risk threshold being able to avoid additional morbidity associated with additional treatment; and the Company’s strategic imperatives under the caption “About Myriad Genetics.” These “forward-looking statements” are management’s present 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 described or implied in the forward-looking statements. These risks include, but are not limited to: the risk that sales and profit margins of the Company’s existing molecular diagnostic tests and pharmaceutical and clinical services may decline or will not continue to increase at historical rates; risks related to the Company’s ability to successfully transition from its existing product portfolio to its new tests; risks related to changes in the governmental or private insurers’ reimbursement levels for the Company’s tests or the Company’s ability to obtain reimbursement for its new tests at comparable levels to its existing tests; risks related to increased competition and the development of new competing tests and services; the risk that the Company 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 the Company may not successfully develop new markets for its molecular diagnostic tests and pharmaceutical and clinical services, including the Company’s ability to successfully generate revenue outside the United States; the risk that licenses to the technology underlying the Company’s molecular diagnostic tests and pharmaceutical and clinical services tests and any future tests are terminated or cannot be maintained on satisfactory terms; risks related to delays or other problems with operating the Company’s laboratory testing facilities; risks related to public concern over the Company’s genetic testing in general or the Company’s 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 the Company’s ability to obtain new corporate collaborations or licenses and acquire new technologies or businesses on satisfactory terms, if at all; risks related to the Company’s ability to successfully integrate and derive benefits from any technologies or businesses that it licenses or acquires; risks related to the Company’s projections about the potential market opportunity for the Company’s products; the risk that the Company or its licensors may be unable to protect or that third parties will infringe the proprietary technologies underlying the Company’s tests; the risk of patent-infringement claims or challenges to the validity of the Company’s patents; risks related to changes in intellectual property laws covering the Company’s molecular diagnostic tests and pharmaceutical and clinical services and patents or enforcement in the United States and foreign countries, such as the Supreme Court decisions Mayo Collab. Servs. v. Prometheus Labs., Inc., 566 U.S. 66 (2012), Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013), and Alice Corp. v. CLS Bank Int’l, 573 U.S. 208 (2014); risks of new, changing and competitive technologies and regulations in the United States and internationally; the risk that the Company may be unable to comply with financial operating covenants under the Company’s credit or lending agreements; the risk that the Company will be unable to pay, when due, amounts due under the Company’s credit or lending agreements; and other factors discussed under the heading “Risk Factors” contained in Item 1A of the Company’s 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 the Company’s Quarterly Reports on Form 10-Q or Current Reports on Form 8-K.



Posted: 2020-02-14 12:05:00

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