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Myriad Genetics Receives FDA Approval of the MyChoice CDx Test as the Companion Diagnostic for Zejula (niraparib) for Patients with Ovarian Cancer
Approval reinforces Myriad’s leadership in comprehensive HRD testing and establishes MyChoice CDx as the only FDA-approved companion diagnostic for Zejula in
About this update from Myriad Genetics, Inc.
[{"type":"text","content":"Approval reinforces Myriad’s leadership in comprehensive HRD testing and establishes MyChoice CDx as the only FDA-approved companion diagnostic for Zejula in the United States\nSALT LAKE CITY, March 17, 2026 (GLOBE NEWSWIRE) -- 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). “The FDA approval reinforces Myriad’s long-standing leadership in ovarian cancer diagnostics and underscores the clinical importance of comprehensive HRD testing,” said Brian Donnelly, Chief Commercial Officer, Myriad Genetics. “By enabling precise identification of patients who may benefit from PARP inhibitors, MyChoice CDx helps ensure that treatment decisions are guided by robust genomic insights.” Nearly 50% of patients with advanced ovarian cancer have HRD positive (HRD+) tumors.1 Identifying these patients is critical to ensuring appropriate use of PARP inhibitor therapy and improving personalized treatment decisions.1-4 Zejula is a prescription medicine used for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer whose cancer is associated with HRD+ status defined by a deleterious or suspected deleterious BRCA mutation and/or genomic instability. Zejula is used after the cancer has responded (complete or partial response) to treatment with first-line platinum-based chemotherapy (Zejula indications refe...