Myriad Genetics, Inc., (NASDAQ:MYGN), a leader in molecular diagnostic testing and precision medicine, today announced that the U.S. Food and Drug Administration (FDA) has approved the MyChoice® CDx Test as the Companion Diagnostic (CDx) for Zejula® (niraparib), a PARP inhibitor from GSK, for patients with advanced ovarian cancer.

This approval is based on final data from the PRIMA trial, where the MyChoice CDx Test determined homologous recombination deficiency (HRD) status and was used to stratify advanced ovarian cancer patients.

The MyChoice CDx is the only FDA-approved companion diagnostic test in the United States to identify patients with HRD-positive status eligible for treatment with Zejula. The test determines HRD status by leveraging next generation sequencing technology to conduct a comprehensive assessment of BRCA1/2 genes -- including large rearrangements -- and tumor genomic instability score (GIS) that includes loss of heterozygosity (LOH), telomeric allelic imbalance (TAI) and large-scale state transitions (LST).