Myriad Genetics Blog Myriad Genetics Blog > BRACAnalysis CDx Approved by FDA for Patients with HER2- Metastatic Breast Cancer BRACAnalysis CDx Approved by FDA for Patients with HER2- Metastatic Breast Cancer January 23, 2018 Breast Cancer Corporate The U.S. Food and Drug Administration (FDA) has approved BRACAnalysis CDx® for use as a companion diagnostic to identify patients with HER2- metastatic breast cancer who are candidates for treatment with AstraZeneca’s PARP inhibitor, Lynparza®(Olaparib). BRACAnalysis CDx is the only FDA-approved test for use in this important indication. The approval of BRACAnalysis CDx underscores the need for patients with metastatic breast cancer to know their BRCA status and to help them receive the best available therapy. As was shown in the OlympiAD study, the BRACAnalysis CDx test was proven to accurately identify those patients who benefited from treatment with Lynparza. Myriad Genetics is actively working with all stakeholders to raise awareness of BRACAnalysis CDx, so that patients with HER2- metastatic breast cancer can be immediately tested to determine if they are likely to benefit from Lynparza. You can get more information about BRACAnalysis CDx by visiting www.Myriad.com or by calling us at 1-800 469-7423.