Myriad Genetics Inc, Salt Lake City, has announced the expansion of its companion diagnostic collaboration with pharma giants AstraZeneca, Cambridge, UK, and Merck, Kenilworth, NJ (known as MSD outside of the United States and Canada).
Under the expanded collaboration, the companies will use Myriad’s BRACAnalysis companion diagnostic to identify germline BRCA mutations in men who have metastatic castration-resistant prostate cancer (mCRPC) and are enrolled in the Phase III Profound study. If the study is successful, Myriad intends to file a supplementary premarket approval application with FDA for BRACAnalysis to be used as a companion diagnostic to qualify individuals from this patient population for the use of Lynparza (olaparib).
BRACAnalysis is a companion diagnostic intended for the qualitative detection and classification of variants in the protein-coding regions and intron-exon boundaries of the BRCA1 and BRCA2 genes using genomic DNA obtained from whole blood specimens collected in ethylenediaminetetraacetic acid. Single-nucleotide variants and small insertions and deletions (indels) are identified by polymerase chain reaction (PCR) and Sanger sequencing. Large deletions and duplications in BRCA1 and BRCA2 are detected using multiplex PCR.
“Our companion diagnostic collaboration with AstraZeneca and Merck has led to significant advancements in precision treatment for patients with ovarian and breast cancer,” says Nicole Lambert, president of Myriad Oncology. “However, 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 poly-ADP ribose polymerase (PARP) inhibitors is being explored. We look forward to this exciting opportunity to potentially expand the use of BRACAnalysis CDx in this setting.”
For further information, visit Myriad Genetics.