Agilent Companion Diagnostic Gains CE-IVD Mark for Cervical Cancer in Europe

Agilent Technologies has received expanded CE-IVD marking in Europe for its PD-L1 IHC 22C3 pharmDx companion diagnostic test, now including its use in cervical cancer. The test can aid in identifying patients with cervical cancer eligible for treatment with KEYTRUDA®, an anti-PD-1 therapy developed by Merck.

In Europe, KEYTRUDA is indicated, in combination with chemotherapy with or without bevacizumab, for adult patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 with a Combined Positive Score (CPS) of 1 or greater. This marks a significant step in making targeted immunotherapies accessible for this patient population.

PD-L1 expression is a critical biomarker for response to anti-PD-1 therapies, and its importance is growing across various cancer types. Cervical cancer is a significant global health concern, particularly for women, with tens of thousands of new cases diagnosed in Europe annually. Agilent's measure aims to improve outcomes by facilitating access to appropriate treatments.

According to Agilent, the PD-L1 IHC 22C3 pharmDx is currently the only CE-IVD marked companion diagnostic intended to aid in identifying cervical cancer patients with PD-L1 CPS ≥ 1 for KEYTRUDA therapy. This expansion reinforces Agilent's role in developing immunohistochemistry-based diagnostics for targeted cancer treatments.