NEW YORK (GenomeWeb) – Myriad Genetics announced today it has expanded its collaboration with AstraZeneca and Merck to use its BRACAnalysis CDx test to identify men with metastatic, castrate-resistant prostate cancer (mCRPC) and germline BRCA mutations who are likely to respond to olaparip (Lynparza).
Myriad said that depending on the success of the study, it intends to file a supplementary premarket approval application with the US Food and Drug Administration for use of BRACAnalysis CDx as a companion diagnostic for the drug for this specific patient population.
"There is a significant unmet medical need in men with metastatic, castration-resistant prostate cancer and BRCA1/2 mutations, which is an area where the utility of PARP inhibitors is being explored," Nicole Lambert, president of Myriad Oncology, said in a statement. Â
The collaboration between Myriad and AstraZeneca started in 2007, and since then BRACAnalysis CDx has been approved by the FDA as a companion test for Lynparza in several ovarian and breast cancer indications. Â