Myriad Genetics announced that the U.S. Food and Drug Administration approved its MyChoice CDx Test as the companion diagnostic for Zejula (niraparib), a PARP inhibitor used to treat advanced ovarian cancer. The approval, granted on March 17, 2026, follows the final data from the PRIMA trial, which demonstrated that the test accurately determines homologous recombination deficiency (HRD) status in patients.
The PRIMA trial data underpinning the approval showed that MyChoice CDx can identify approximately 50% of advanced ovarian cancer patients with HRD‑positive tumors, a critical biomarker for selecting patients likely to benefit from Zejula. The FDA’s decision makes MyChoice CDx the only U.S.‑approved HRD test referenced in American Society of Clinical Oncology guidelines for patient selection, solidifying its clinical relevance.
The regulatory win is expected to strengthen Myriad’s oncology portfolio and drive increased adoption of the test, potentially expanding revenue from the companion diagnostic market. The approval also aligns with the company’s strategy to focus on precision diagnostics, positioning it to capture a larger share of the growing PARP inhibitor market and reinforcing its competitive advantage in ovarian cancer care.
Myriad’s Q4 2025 earnings, released on February 23, 2026, beat analyst expectations with an adjusted EPS of $0.04 versus a consensus of –$0.02, while revenue of $209.8 million matched year‑over‑year estimates. The earnings beat was largely driven by disciplined cost management and a favorable mix of high‑margin diagnostic services. The company reiterated its 2026 revenue guidance of $860 million to $880 million, indicating confidence in continued growth as the new approval expands its market reach.
Brian Donnelly, Chief Commercial Officer, said, “The FDA approval reinforces Myriad’s long‑standing leadership in ovarian cancer diagnostics and underscores the clinical importance of comprehensive HRD testing.” The approval, coupled with the recent earnings beat, signals strong execution and positions Myriad to capitalize on the expanding PARP inhibitor market.
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