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Agilent Obtains CE-IVD Mark for CDx to ID Cervical Cancer Patients Suitable for Keytruda

NEW YORK ─ Agilent Technologies announced Tuesday that it has obtained the CE mark for its PD-L1 IHC 22C3 pharmDx companion diagnostic assay for use in cervical cancer.

The assay can be used as an aid to identify cervical cancer patients for whom treatment with Merck's anti-PD-1 therapy Keytruda (pembrolizumab) may be appropriate, Agilent said.

"With this European indication expansion of PD-L1 IHC 22C3 pharmDx into cervical cancer, pathologists have access to reliable diagnostic results, supporting even more cancer patients who could benefit from targeted therapies," Sam Raha, president of Agilent’s Diagnostics and Genomics Group, said in a statement.

In Europe, pembrolizumab along with chemotherapy with or without Genentech's Avastin (bevacizumab) is indicated for the treatment of persistent, recurrent, or metastatic cervical cancer in adults whose tumors express PD-L1, Agilent said.

Last October, Agilent said it had obtained CE marking for the expanded use of its PD-L1 IHC 22C3 pharmDx CDx to identify patients with triple-negative breast cancer in the European Union.