Agilent Expands Companion Diagnostic Portfolio with EU Nod for Ovarian Cancer Test
Event summary
- Agilent received EU certification for PD-L1 IHC 22C3 pharmDx as a companion diagnostic for epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.
- The approval enables identification of patients eligible for Merck's KEYTRUDA® therapy in the platinum-resistant setting.
- This marks the eighth CE-marked indication for PD-L1 IHC 22C3 pharmDx in the EU.
- Approval was supported by data from the KEYNOTE-B96/ENGOT-ov65 clinical trial.
The big picture
This approval strengthens Agilent's position in the growing precision oncology space, particularly as demand increases for targeted cancer therapies. The expansion of PD-L1 IHC 22C3 pharmDx indications aligns with broader industry trends toward personalized medicine and immunotherapy advancements. With $6.95 billion in revenue (FY 2025), Agilent continues to invest in diagnostic innovations that support treatment decisions for challenging cancer types.
What we're watching
- Market Expansion
- How Agilent will leverage this approval to expand its presence in European precision oncology markets.
- Commercialization Pace
- The speed at which clinical labs adopt the new diagnostic indication for ovarian cancer treatment decisions.
- Strategic Partnerships
- Whether Agilent's collaboration with Merck will extend to additional companion diagnostics beyond KEYTRUDA®.
Related topics