Posted by Michael Wonder on 12 Mar 2022
Myriad Genetics receives FDA approval of BRACAnalysis CDx as a companion diagnostic for Lynparza in early breast cancer
11 March 2022 - 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.
Myriad Genetics today announced the U.S. FDA has approved Myriad’s BRACAnalysis CDx test for use as a companion diagnostic to identify patients with germline BRCA mutated HER2 negative, high risk early stage breast cancer who may benefit from Lynparza (olaparib).
