Agilent Receives European IVDR Certification for Companion Diagnostic Assay

30 August 2023 | Wednesday | News

Agilent Technologies Inc. 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).
Image Source : Public Domain

Image Source : Public Domain

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, esophageal cancer, and triple-negative breast cancer (TNBC). Furthermore, the IVDR certification covers NSCLC for LIBTAYO. 

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. 

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. 

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