Recent Device Approval: FoundationFocus CDxBRCA LOH

FDA has recently approved the FoundationFocus™ CDx BRCA LOH. This was originally approved as a companion diagnostic designed to detect the presence of mutations in the BRCA1 and BRCA2 genes. The laboratory test can also be used to detect the percentage of genomic loss of heterozygosity (LOH) in tumor tissue samples from patients with ovarian cancer. BRCA1 and BRCA2 stand for Breast Cancer, early onset genes 1 and 2, which are also associated with ovarian cancer. LOH is a genetic event that occurs in many cancer types, and results in the loss of one allele (or copy) of a genetic locus. Patients with BRCA mutations or a high percentage of LOH are classified as positive for homologous recombination deficiency (HRD), which means cells are less able to repair harmful breaks on both strands of DNA. If BRCA mutations are detected or patients have positive HRD status, the patients may be considered for treatment with Rubraca (rucaparib).