Myriad Announces HRD Companion Diagnostic Collaboration

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News Desk 2018
Myriad Announces HRD Companion Diagnostic Collaboration With Tesaro

SALT LAKE CITY, March 24, 2014 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (Nasdaq: MYGN ) today announced that Tesaro, Inc. will use Myriad's novel HRD (homologous recombination deficiency) test to identify tumor types that may respond to its investigational poly-ADP ribose polymerase (PARP) inhibitor, niraparib, currently in Phase 3 clinical development. Specific terms of the deal were not disclosed.

"The biology of cancer is complex and increasingly the goal of oncology is to use a companion diagnostic to pair a tumor type with the targeted activity of a specific medicine. Prior studies have shown that only a subset of patients will respond to PARP inhibitors. HRD is the most comprehensive test to identify those patients who might respond to treatment," said Jerry Lanchbury, Ph.D., chief scientific officer at Myriad. "The HRD test is engineered to look for evidence of genomic disrepair, which appears as a DNA scar. We believe using the HRD test may capture an enhanced number of responders to treatment with the exciting new class of PARP inhibitors."

The research agreement with Tesaro is Myriad's fifth collaboration with a major pharmaceutical company to evaluate HRD. Myriad estimates the global market for an HRD test could exceed $3 billion as oncologists move toward personalized medicine and targeted therapies.    

"As an innovation-focused company, we are leading the way in developing breakthrough companion diagnostics that have the potential to create significant value for patients and physicians," said Lanchbury. "We also strive to be the research partner of choice. Myriad has a proven track record of providing our pharmaceutical partners with what they need to move their products forward and achieve success."

About HRD ( Homologous Recombination Deficiency)

Myriad's proprietary HRD test detects when a tumor has lost the ability to repair double-stranded DNA breaks resulting in increased susceptibility to DNA-damaging drugs. High HRD scores are prevalent in all breast cancer subtypes and most other major cancers. In previously published data, Myriad showed that the HRD test predicted drug response to platinum therapy in triple-negative breast cancer patients. It is estimated that 490,000 people in the United States who are diagnosed with cancers annually are candidates for treatment with DNA-damaging agents.

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 website: www.myriad.com .

Myriad, the Myriad logo and Prolaris, Myriad myPath, Myriad myPlan, Myriad myRisk, 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 Tesaro's evaluation of the Company's novel HRD (homologous recombination deficiency) test to identify tumor types that may respond to Tesaro's investigational poly-ADP ribose polymerase (PARP) inhibitor, niraparib, currently in Phase 3 clinical development; the Company's belief that using our HRD approach has the potential to capture an enhanced number of responders to treatment with the exciting new class of PARP inhibitors; the Company's estimates of the global market for an HRD test exceeding $3 billion as oncologists move toward personalized medicine and targeted therapies; and the Company's strategic directives 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 in the forward-looking statements. These risks include, but are not limited to: the risk that sales and profit margins of our existing molecular diagnostic tests and companion diagnostic services may decline or will not continue to increase at historical rates; risks related to changes in the governmental or private insurers reimbursement levels for our tests; the risk that we may be unable to develop or achieve commercial success for additional molecular diagnostic tests and companion diagnostic services in a timely manner, or at all; the risk that we may not successfully develop new markets for our molecular diagnostic tests and companion diagnostic 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 companion diagnostic services tests and any future tests are terminated or cannot be maintained on satisfactory terms; risks related to delays or other problems with operating our laboratory testing facilities; risks related to public concern over our 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; 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 companion diagnostic 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 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 Investor Contact: Scott Gleason (801) 584-1143

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