Myriad Genetics received FDA approval for its MyChoice CDx test as a companion diagnostic to identify homologous recombination deficiency (HRD) and BRCA mutations in patients eligible for GSK’s PARP inhibitor Zejula (niraparib). The approval stems from final PRIMA trial data where MyChoice was used to stratify advanced ovarian cancer patients. MyChoice uses NGS to report BRCA1/2 status and a tumor genomic instability score; Myriad said nearly half of advanced ovarian tumors are HRD‑positive. The FDA decision enables clinicians to use a validated assay to guide maintenance therapy decisions with Zejula across HRD‑positive populations. Diagnostics and oncology teams should expect Myriad’s clearance to shape testing algorithms and companion diagnostic workflows for PARP therapy selection in ovarian cancer.