Agilent receives European IVDR certification for companion diagnostic assay

Agilent Technologies (A) announced the issuing of a companion diagnostic, CDx, Class C IVDR certification for PD-L1 IHC 22C3 pharmDx, Code SK006. This CDx assay has previously been CE-IVD-marked for sales in the European Union and is now certified in accordance with the new EU Regulation for in vitro diagnostic medical devices, IVDR. PD-L1 IHC 22C3 pharmDx, Code SK006, is indicated as an aid in identifying certain cancer patients for treatment with KEYTRUDA , Merck’s anti-PD-1 therapy, and Regeneron’s anti-PD-1 therapy LIBTAYO. The IVDR certification covers five CDx cancer indications for KEYTRUDA: non-small cell lung cancer , urothelial carcinoma, head and neck squamous cell carcinoma, esophageal cancer, and triple-negative breast cancer . Furthermore, the IVDR certification covers NSCLC for LIBTAYO. Sam Raha, president of Agilent’s Diagnostics and Genomics Group, commented on the importance of this announcement: “CDx assays are critical diagnostic products for pathology laboratories as they support cancer patients who could benefit from targeted therapies.” Jenipher Dalton, senior vice president of Agilent’s Global Quality and Regulatory Affairs, added: “With this IVDR certification of a Class C-CDx device, Agilent remains committed to continuously supporting laboratories in Europe with high-quality solutions for the benefit of healthcare professionals and patients.” As an innovative industry leader with more than 50 years’ experience, Agilent launched the first FDA-approved companion diagnostic and continues to deliver world-class CDx products in close collaboration with pharma partners. KEYTRUDA is a registered trademark of Merck (MRK). LIBTAYO is a registered trademark of Regeneron Pharmaceuticals (REGN).