Based on the positive outcome of a Phase 3 study evaluating AstraZeneca and Merck’s PARP inhibitor Lynparza (olaparib) in men with metastatic castration-resistant prostate cancer (mCRPC) with BRCA1/2 or ATM mutations, Myriad Genetics (MYGN -1%) plans to pursue FDA approval of its BRACAnalysis CDx test as a companion diagnostic for olaparib in BRCA mutation-positive mCRPC patients.
The company has been collaborating with AstraZeneca on olaparib since 2007. BRACAnalysis CDx is currently approved in the U.S. as a companion diagnostic in breast and ovarian cancer patients.
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