Myriad Genetics, Inc., (MYGN) announced that the U.S. FDA has approved its MyChoice CDx Test as the companion diagnostic for Zejula, a PARP inhibitor developed by GSK, for patients with advanced ovarian cancer.
The approval is based on final data from the PRIMA trial, where the MyChoice CDx Test was used to determine homologous recombination deficiency (HRD) status and stratify patients. Nearly half of women with advanced ovarian cancer have HRD-positive tumors, making accurate identification critical for guiding treatment decisions.
The MyChoice CDx Test is now the only FDA-approved companion diagnostic for Zejula in the United States. It uses next-generation sequencing to assess BRCA1/2 genes- including large rearrangements- and a tumor genomic instability score that incorporates multiple markers such as loss of heterozygosity and telomeric allelic imbalance.
Brian Donnelly, Chief Commercial Officer at Myriad Genetics, said the approval reinforces the company's leadership in ovarian cancer diagnostics and highlights the importance of comprehensive HRD testing. By enabling precise identification of patients who may benefit from PARP inhibitors, the test ensures treatment decisions are guided by robust genomic insights.
Zejula is indicated in the U.S. for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who respond to first-line platinum-based chemotherapy and whose cancer is associated with HRD-positive status.
This FDA decision marks a significant milestone for Myriad Genetics, strengthening its position in precision medicine and expanding its role in guiding personalized cancer care.
MYGN has traded between $3.76 and $10.40 over the past year. The stock closed Tuesday's trading session at $4.78, up 4.14%. During overnight trading, the stock fell to $4.70, down 1.67%.
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