Myriad's BRACAnalysis CDx(R) cupplementary PMA accepted by FDA for review
Myriad Genetics announced the FDA has accepted its sPMA for BRACAnalysis CDx® to be used as a companion diagnostic with AstraZeneca's PARP inhibitor Lynparza® (olaparib) in patients with HER2-negative metastatic breast cancer. Myriad expects the FDA's priority review process to conclude in 2018. October 18, 2017