Agilent Secures FDA Nod for Ovarian Cancer Companion Diagnostic
Event summary
- Agilent's PD-L1 IHC 22C3 pharmDx received FDA approval for identifying epithelial ovarian cancer patients eligible for KEYTRUDA treatment.
- This marks the seventh FDA-approved companion diagnostic indication for the test, expanding its use to seven cancer types.
- The approval is based on data from the KEYNOTE-B96 clinical trial, supporting first-line treatment decisions.
- Ovarian cancer caused approximately 12,730 deaths in the U.S. in 2025, with a 5-year survival rate of 51.6%.
- The diagnostic was developed in partnership with Merck & Co., the maker of KEYTRUDA.
The big picture
This FDA approval solidifies Agilent's position as a leader in companion diagnostics, particularly in the rapidly evolving field of immuno-oncology. The expansion of PD-L1 IHC 22C3 pharmDx to ovarian cancer underscores the growing importance of precision medicine in treating aggressive cancers. With Merck's KEYTRUDA as the therapeutic partner, Agilent is well-positioned to capitalize on the increasing demand for personalized cancer treatments.
What we're watching
- Market Expansion
- How Agilent will leverage this approval to expand its presence in the immuno-oncology diagnostics market.
- Partnership Dynamics
- Whether Agilent and Merck can sustain their collaborative advantage in developing companion diagnostics.
- Clinical Adoption
- The pace at which pathologists and oncologists integrate this diagnostic into standard ovarian cancer treatment protocols.
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