On March 17, 2026 Myriad Genetics, Inc., (NASDAQ: MYGN), a leader in molecular diagnostic testing and precision medicine, reported 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.
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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 referenced here apply to the US only). (For other indications, see "About Zejula" section below).
To learn more about the MyChoice CDx Test and how it can support treatment decisions for patients eligible for Zejula, please visit View Source
About the MyChoice CDx Test
The MyChoice CDx Test is the only FDA-approved homologous recombination deficiency (HRD) test specifically mentioned in American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) guidelines for selecting patients with ovarian cancer who may benefit from poly [ADP-ribose] polymerase (PARP) inhibitors.5 The MyChoice CDx Test determines HRD status by conducting a comprehensive assessment of BRCA1/2 genes and tumor genomic instability score (GIS) that includes loss of heterozygosity (LOH), telomeric allelic imbalance (TAI) and large-scale state transitions (LST). The MyChoice CDx Test can identify 34% more patients with HRD than other tumor tests that use %LOH alone.1
About Zejula (niraparib)
Zejula is an oral, once-daily poly (ADP ribose) polymerase (PARP) inhibitor that works by preventing DNA repair in tumor cells, ultimately leading to their death. Zejula is indicated in the US for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD)-positive status.
Zejula is also indicated for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy and who have been selected based on a US FDA-approved companion diagnostic for Zejula (Zejula indications referenced here apply to the US only).
(Press release, Myriad Genetics, MAR 17, 2026, View Source [SID1234663676])