Biomarker offers another companion diagnostic option to establish eligibility for FDA-approved drug ELAHERE®
SALT LAKE CITY, May 24, 2023 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in genetic testing and precision medicine, today announced the addition of Folate Receptor Alpha (FRα) to its Precise™ Oncology Solutions portfolio. The new biomarker adds another companion diagnostic option for providers to help guide treatment decisions for patients with ovarian cancer.
FRα is a biomarker commonly expressed in patients with ovarian cancer. FRα establishes patient eligibility for ELAHERE® (“mirvetuximab soravtansine-gynx”), the only FDA-approved drug indicated for patients who are FRα-positive and resistant to platinum-based chemotherapy. FRα is a newly recommended biomarker test included in the National Comprehensive Cancer Network treatment guidelines for ovarian cancer. According to the SORAYA study, 36% of patients screened were found to have high tumor FRα expression, representing a significant proportion of patients with ovarian cancer who could potentially benefit from MIRV-based therapy.
“FRα, alongside germline and homologous recombination deficiency status, can be a powerful biomarker for patients with ovarian cancer to create a comprehensive treatment plan,” said Ramez N. Eskander, associate professor in the Department of Obstetrics, Gynecology, and Reproductive Sciences at UC San Diego School of Medicine. “Patients will benefit from Myriad’s addition of FRα testing to their Precise Oncology Solutions portfolio to help improve outcomes for this patient group.”
FRα is available immediately and can be ordered alongside other companion diagnostic test offerings through the Myriad ordering portal. For a streamlined workflow and quicker path to making treatment decisions, oncologists can receive germline, HRD, FRα biomarker and tumor testing results from a single laboratory.
“The expansion of our portfolio with FRα highlights our commitment to continually growing and innovating to support oncologists with comprehensive, data-driven genetic insights that can better inform treatment decisions for their patients,” said Michael Lyons, general manager of Oncology, Myriad Genetics.
About Myriad GeneticsMyriad Genetics is a leading genetic testing and precision medicine company dedicated to advancing health and well-being for all. Myriad develops and offers genetic tests that help assess the risk of developing disease or disease progression and guide treatment decisions across medical specialties where genetic insights can significantly improve patient care and lower healthcare costs. For more information, visit www.myriad.com.
Myriad, the Myriad logo, and Precise are registered trademarks or trademarks of Myriad Genetics, Inc. All third-party marks—® and ™—are the property of their respective owners.
ABOUT ELAHEREELAHERE (mirvetuximab soravtansine-gynx) is a first-in-class antibody-drug conjugate (ADC) comprising a folate receptor alpha-binding antibody, cleavable linker, and the maytansinoid payload DM4, a potent tubulin inhibitor designed to kill the targeted cancer cells. Please see the full Prescribing Information, including a Boxed Warning, for ELAHERE here.
ELAHERE® is a registered trademark of ImmunoGen, Inc.
Safe Harbor StatementThis press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the addition of FRα to the Precise Oncology Solutions portfolio, FRα testing will help improve outcomes for ovarian cancer patients, and the company’s commitment to continually growing and innovating to support oncologists with comprehensive, data-driven genetic insights that can better information treatment decisions for their patients. These “forward-looking statements” are management’s expectations of future events as of the date hereof and are subject to known and unknown risks and uncertainties that could cause actual results, conditions, and events to differ materially and adversely from those anticipated. Such factors include those risks described in the company’s filings with the U.S. Securities and Exchange Commission, including the company’s Annual Report on Form 10-K filed on March 1, 2023, 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. Myriad is not under any obligation, and it expressly disclaims any obligation, to update or alter any forward-looking statements, whether as a result of new information, future events or otherwise except as required by law.