Myriad Genetics Secures FDA Nod For GSK Cancer Diagnostic

Edgen Stock

·Mar 17 2026, 20:21

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Key Takeaways

Myriad Genetics received U.S. Food and Drug Administration (FDA) approval for its MyChoice CDx test, positioning it as a required companion diagnostic for a GSK ovarian cancer therapy. This regulatory milestone directly links Myriad's diagnostic product to a major pharmaceutical treatment, creating a new and specific revenue channel.

Regulatory Approval: On March 17, 2026, the FDA approved Myriad Genetics' MyChoice CDx test.
Companion Diagnostic: The test will identify ovarian cancer patients suitable for treatment with GSK's drug, Zejula (niraparib), a PARP inhibitor.
Commercial Impact: The approval establishes a new revenue stream for Myriad (MYGN) by making its test a prerequisite for patients accessing a specific, high-value therapy.

FDA Greenlights MyChoice CDx Test on March 17

Myriad Genetics secured a critical U.S. Food and Drug Administration (FDA) approval on March 17, 2026, for its MyChoice CDx test. The approval designates the test as the official companion diagnostic for Zejula (niraparib), a PARP inhibitor developed by GSK. This regulatory action authorizes the test to identify ovarian cancer patients who are candidates for treatment with Zejula, effectively making Myriad's diagnostic an essential step in the clinical pathway for this specific therapy.

Approval Forges New Revenue Channel with GSK

The FDA's decision provides Myriad Genetics with a significant commercial victory, creating a direct revenue stream tied to the prescription of GSK's established cancer drug. By becoming a required companion diagnostic, Myriad's sales for the MyChoice CDx test are now linked to the market uptake of Zejula for this patient population. This development solidifies Myriad's strategic position in the personalized medicine sector, where diagnostic tests guide targeted and more effective treatments. For investors, the approval de-risks a portion of Myriad's commercial pipeline and signals a clear path to increased sales volume.