Agilent Gains After EU Approves Ovarian Cancer Diagnostic for Keytruda

Agilent Technologies Inc. (NYSE:A) shares climbed in premarket trading on Thursday after the company announced it had secured European Union certification for a key cancer diagnostic. The stock rose 3.2% following the news of the approval.

Details of the Approval

The certification applies to Agilent's PD-L1 IHC 22C3 pharmDx, a companion diagnostic test. According to the company's announcement, the approval allows its use to identify patients with epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumors express the PD-L1 protein.

This is significant for clinicians as it helps determine which patients may be eligible for treatment with Merck’s immunotherapy drug, KEYTRUDA (pembrolizumab). The diagnostic provides a critical tool for guiding treatment decisions in cancers where therapeutic options can be limited.

Expanding Diagnostic Portfolio

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This marks the eighth CE-marked indication for the PD-L1 IHC 22C3 pharmDx in the European Union, underscoring the diagnostic's expanding utility across various cancer types. The ovarian cancer approval was supported by data from the KEYNOTE-B96/ENGOT-ov65 clinical trial.

Agilent, which developed the test in partnership with Merck, noted that the diagnostic is also approved in the EU to help identify patients for KEYTRUDA treatment in several other cancers, including:

• Non-small cell lung cancer
• Triple-negative breast cancer
• Esophageal and cervical cancers
• Head and neck squamous cell carcinoma
• Gastric or gastroesophageal junction adenocarcinoma
• Urothelial carcinoma