Agilent companion diagnostic expands CE-IVD Mark in Europe to include cervical cancer

Agilent Technologies says its PD-L1 IHC 22C3 pharmDx, Code SK006, is now EU CE-IVD–marked for use in cervical cancer. PD-L1 IHC 22C3 pharmDx can be used as an aid in identifying cervical cancer patients for whom treatment with KEYTRUDA (pembrolizumab) may be appropriate. 

KEYTRUDA is an anti-PD-1 therapy developed by Merck (known as MSD outside the U.S. and Canada). In Europe, KEYTRUDA, in combination with chemotherapy with or without bevacizumab, is indicated for the treatment of persistent, recurrent, or metastatic cervical cancer in adults whose tumours express PD-L1 [Combined Positive Score (CPS) ≥ 1].

PD-L1 expression is a critical biomarker for response to anti-PD-1 therapies such as KEYTRUDA whose therapeutic value is being demonstrated across a growing list of cancer types. 

Sam Raha, president of Agilent’s Diagnostics and Genomics Group, said: “PD-1/PD-L1-targeted immunotherapies such as KEYTRUDA have become important cancer treatment options for a growing number of patients. 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.”

Currently, PD-L1 IHC 22C3 pharmDx is the only CE-IVD marked companion diagnostic indicated as an aid in identifying cervical cancer patients with PD-L1 CPS ≥ 1 for treatment with KEYTRUDA. This indication expansion extends the scope of patients who can be tested to determine eligibility for KEYTRUDA.