Myriad Genetics Receives FDA Approval of the MyChoice CDx Test as the Companion Diagnostic for Zejula (niraparib) for Patients with Ovarian Cancer

Core Insights - Myriad Genetics has received FDA approval for the MyChoice® CDx Test as a Companion Diagnostic for Zejula® (niraparib) in patients with advanced ovarian cancer [1][4] Group 1: FDA Approval and Clinical Significance - 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 in advanced ovarian cancer patients [2] - MyChoice CDx is the only FDA-approved test in the U.S. for identifying HRD-positive patients eligible for Zejula treatment, utilizing next-generation sequencing technology to assess BRCA1/2 genes and tumor genomic instability [3][6] Group 2: Importance of HRD Testing - Nearly 50% of patients with advanced ovarian cancer have HRD-positive tumors, making the identification of these patients crucial for appropriate PARP inhibitor therapy [4] - The MyChoice CDx Test can identify 34% more HRD-positive patients compared to other tests that rely solely on loss of heterozygosity [6] Group 3: Zejula Overview - Zejula is indicated for maintenance treatment in adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who have HRD-positive status and have responded to first-line platinum-based chemotherapy [7][8]