Myriad Oncology, AztraZeneca and MSD (Merck) will BRACAnalysis CDx to identify germline BRCA mutations in men who have metastatic castrate-resistant prostate cancer.
Myriad, AstraZeneca and MSD (Merck) have been collaborating on the development of companion diagnostics since 2007. These efforts have led to the advances in precision treatment for patients with ovarian and breast cancer, according to Myriad’s president Nicole Lambert.
The companies recently expanded their collaboration in order to focus on the development of a companion diagnostic for men who have metastatic castration-resistant prostate (mCRPC) cancer. PARP inhibitors are being investigated as treatments for this disease. The collaboration will use Myriad’s BRACAnalysis CDx, an in vitro diagnostic device intended for the qualitative detection and classification of variants in the protein coding regions and intron/exon boundaries of the BRCA1 and BRCA2 genes, to identify individuals with germline BRCA mutations with mCRPC who are enrolled in the phase III PROfound (NCT02987543) study.
If the collaboration is successful, Myriad will file a supplementary premarket approval application with the U.S. Food and Drug Administration (FDA) for BRACAnalysis CDx to be used as a companion diagnostic to Lynparza (olaparib).