FDA okays Myriads' BRACAnalysis as companion diagnostics for Lynparz
Myriad Genetics announced that the U.S. Food and Drug Administration approved BRACAnalysis CDx for use as a companion diagnostic by healthcare professionals to identify patients with HER2-negative metastatic breast cancer who have a germline BRCA mutation and are candidates for treatment with the PARP inhibitor Lynparza, marketed by AstraZeneca and Merck, known as MSD outside of the U.S. and Canada. BRACAnalysis CDx is the first and only FDA-approved test for use in this indication."This important advance underscores the need for patients with HER2-negative metastatic breast cancer to know their BRCA status with an FDA approved test to help ensure that they will receive the best available therapy," said Johnathan Lancaster, M.D., Ph.D., chief medical officer of Myriad Genetics. "As shown in the OlympiAD study, Myriad's BRACAnalysis CDx test was proven to accurately identify those patients who had a germline BRCA mutation and may benefit from Lynparza."The approval also adds to the body of knowledge about the clinical use and value of companion diagnostics to enable personalized medicine for people with cancer.