MYGN Myriad Genetics, Inc.
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Executive Summary
Myriad Genetics announced FDA approval of its MyChoice® CDx Test as the companion diagnostic for GSK's Zejula (niraparib) in advanced ovarian cancer patients, based on the PRIMA trial data. This makes MyChoice CDx the only FDA-approved test in the U.S. to identify HRD-positive patients eligible for Zejula, reinforcing Myriad's leadership in ovarian cancer diagnostics and expanding the commercial utility of its test.
Actionable Insight
Traders should monitor future revenue guidance and test volume metrics in upcoming earnings; this approval positions Myriad for increased market penetration and potential pricing leverage. Consider long-term upside given exclusivity and alignment with standard-of-care treatment.
Key Facts
- FDA approved Myriad's MyChoice® CDx Test as the companion diagnostic for GSK's Zejula in advanced ovarian cancer.
- The approval is based on final data from the PRIMA trial, using HRD status to stratify patients.
- MyChoice CDx is now the only FDA-approved HRD test in the U.S. for PARP inhibitor eligibility with Zejula.
- The test identifies HRD status via comprehensive BRCA1/2 analysis and genomic instability score (GIS).
- Nearly 50% of advanced ovarian cancer patients have HRD-positive tumors, making this a significant patient population.
Financial Impact
Significant commercial upside potential — test now required for Zejula eligibility, likely increasing adoption and revenue. No direct dollar figure provided, but expands addressable market and strengthens pricing power.
Risk Factors
- Adoption dependent on physician uptake and payer reimbursement.
- Competition from lab-developed tests (LDTs) or future rival CDx approvals.
- Zejula's own market performance and safety profile could impact test utilization.
Market Snapshot
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3257649 |
Track record builds as more directional reports settle.
Filters
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May 27, 2026
16d ago
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Press Release
| $3.93 $4.31 | ▲ +9.67% | ▲ +8.46% | $4.33 (+10.18%) |
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Mar 17, 2026
12w ago
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Press Release
| $4.64 $4.68 | ▲ +0.86% | ▲ +1.58% | $4.33 (−6.68%) |
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Feb 28, 2026
15w ago
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Institutional Cluster
| $5.01 $4.81 | ▼ −3.99% | ▼ −2.78% | $4.33 (−13.57%) |
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Feb 24, 2026
15w ago
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S-3
| $4.78 $5.28 | ▲ +10.46% | ▲ +11.56% | $4.33 (−9.41%) |
US Market Status
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