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Myriad Genetics Receives FDA Approval of BRACAnalysis® CDx as a Companion Diagnostic for Lynparza® in Early Breast Cancer
BRACAnalysis CDx is now the only germline test approved by FDA as a companion diagnostic for treatment of HER2 negative high-risk early-stage breast cancer
About this update from Myriad Genetics, Inc.
[{"type":"text","content":"BRACAnalysis CDx is now the only germline test approved by FDA as a companion diagnostic for treatment of HER2 negative high-risk early-stage breast cancer\nSALT LAKE CITY, March 11, 2022 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc., (NASDAQ: MYGN), a leader in genetic testing and precision medicine, today announced the U.S. Food and Drug Administration (FDA) has approved Myriad’s BRACAnalysis® CDx test for use as a companion diagnostic to identify patients with germline BRCA-mutated (gRBCAm) HER2 negative, high-risk early-stage breast cancer who may benefit from Lynparza®(olaparib). “This most recent regulatory approval confirms the benefits of using biomarkers to help guide care for patients with breast cancer,” said Nicole Lambert, chief operating officer, Myriad Genetics. “Data from the OlympiA trial and numerous other clinical studies continue to demonstrate the power of BRACAnalysis CDx as an effective test for patients deciding on their best treatment options. More patients with breast cancer now potentially qualify for BRCA testing.” BRACAnalysis CDx is intended to detect and interpret germline BRCA1 and BRCA2 variants. The test identifies deleterious or suspected deleterious germline BRCA variants in patients with HER2 negative high-risk early breast cancer. In the OlympiA trial, patients with HER2 negative early-stage breast cancer with BRCA1 or BRCA2 germline pathogenic or likely pathogenic variants, and high-risk clinicopathological factors had a statistically-significant and clinically meaningful improvement with longer survival, free of invasive or distant disease. “Studies have demonstrated that PARP inhibitors are highly effective in patients with BRCA1/BRCA2 mutations. Once we identify these patients, they will have more options for treatment,” said Thomas Slavin, M.D., chief medical officer, Myriad Genetics. “This important advancement underscores the need for breast cancer patients being evaluated for approved therapies to know their BRCA status with an FDA-approved test right after diagnosis to help ensure they will receive the best available therapy. Additionally, the quick adoption of OlympiA criteria by guideline committees greatly supports the advancement of genomics in clinical care.” Lynparza is being commercialized by AstraZeneca and MSD Inc. (MSD: known as Merck & Co., Inc. inside the US and Canada). The...