Agilent Technologies has received 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 (pembrolizumab), Merck’s anti-PD-1 therapy, and Regeneron’s anti-PD-1 therapy LIBTAYO (cemiplimab). The IVDR certification covers five CDx cancer indications for KEYTRUDA: non-small cell
lung cancer (NSCLC), urothelial carcinoma, head and neck squamous cell carcinoma, oesophageal cancer, and triple-negative breast cancer (TNBC). Furthermore, the IVDR certification covers NSCLC for LIBTAYO.