Myriad Genetics’ MyChoice CDx Gains Sole FDA Approval for Zejula Ovarian Cancer Test
Myriad Genetics’ MyChoice CDx Test has been approved by the FDA as the sole companion diagnostic for Zejula in advanced ovarian cancer patients in the US. The test leverages next-gen sequencing to assess BRCA1/2 genes and a genomic instability score, identifying nearly 50% of HRD-positive patients for PARP inhibitor eligibility.
1. FDA Approval and Market Impact
The FDA has designated MyChoice CDx as the only companion diagnostic for Zejula in advanced ovarian cancer, reinforcing Myriad’s leadership in HRD testing. This approval paves the way for the company to capture diagnostic revenues as Zejula expands its maintenance therapy use in the US.
2. Test’s Technical Advantages
MyChoice CDx employs next-generation sequencing to conduct a comprehensive assessment of BRCA1/2 genes—including large rearrangements—and calculates a tumor genomic instability score that integrates LOH, TAI and LST. The test identifies 34% more HRD-positive patients compared to assays relying solely on LOH metrics.
3. Clinical Significance and Adoption
Based on final PRIMA trial data, the test accurately stratifies patients eligible for PARP inhibitor therapy, covering nearly half of advanced ovarian cancer cases with HRD-positive tumors. Its inclusion in clinical guidelines positions MyChoice CDx for rapid adoption by oncologists seeking precise treatment decision tools.