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Agilent receives European IVDR certification for companion diagnostic assay

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.

agilent PD L1 IHC 22C3

Substantial technological and scientific progress in the medical device sector over the last 20 years has highlighted an important need for updated regulations to help ensure the continued safety and performance of a wide range of medical devices. IVDR compliance certification enhances the confidence of healthcare professionals and patients in the EU by showing that these medical devices can be safely relied upon in diagnostic workflows.

PD-L1 is a critical biomarker for response to anti-PD-1 therapy, and Agilent’s PD-L1 IHC 22C3 pharmDx is widely used by pathology laboratories to identify cancer patients eligible for treatment. At the same time, oncologists are increasingly selecting patients for treatment with anti PD-1 therapies in indications across a growing range of cancer types. This IVDR certification allows healthcare professionals and patients to continue to benefit from the assay without disruption to critical diagnostic capabilities in established indications.

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