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Agilent CDx Assay IVDR Certified to ID Cancer Patients for Keytruda, Libtayo Treatment

NEW YORK – Agilent Technologies said Thursday that it has secured CE-IVDR marking for its PD-L1 IHC 22C3 PharmDx companion diagnostic assay for use to identify cancer patients for treatment with anti-PD-1 therapies.

The immunohistochemistry assay is used to aid identification of patients with non-small cell lung cancer (NSCLC), urothelial carcinoma, head and neck squamous cell carcinoma, esophageal cancer, or triple-negative breast cancer who would benefit from Merck's Keytruda (pembrolizumab); and patients with NSCLC who would benefit from Regeneron's Libtayo (cemiplimab).

Agilent had previously secured CE-IVD marking for use of the companion diagnostic to help identify patients for treatment with Keytruda or Libtayo for several of the same cancer types.

"CDx assays are critical diagnostic products for pathology laboratories as they support cancer patients who could benefit from targeted therapies," Agilent Diagnostics and Genomics Group President Sam Raha said in a statement.

Jenipher Dalton, Agilent's senior VP of global quality and regulatory affairs, said in a statement that the firm is committed to supporting European labs with high-quality solutions that benefit healthcare professionals and patients.

In Europe, Keytruda gained marketing authorization in 2015 and is mainly used in adults for advanced, spreading, or returning cancers that are not responsive to other treatments and cannot be removed by surgery, according to the European Medicines Agency. Libtayo gained marketing authorization on the continent in 2019 and is used to treat skin, lung, and cervical cancers that are advanced, metastatic, or difficult to treat with surgery or other chemotherapies.