Agilent Receives European IVDR Certification for Companion Diagnostic Assay
- The IVDR certification enhances confidence in Agilent's PD-L1 IHC 22C3 pharmDx, allowing healthcare professionals and patients to continue benefiting from the assay without disruption in established indications
- None.
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
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 Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc.,
LIBTAYO® is a registered trademark of Regeneron Pharmaceuticals, Inc.
About Agilent Technologies
Agilent Technologies Inc. (NYSE: A) is a global leader in analytical and clinical laboratory technologies, delivering insights and innovation that help our customers bring great science to life. Agilent’s full range of solutions includes instruments, software, services, and expertise that provide trusted answers to our customers' most challenging questions. The company generated revenue of
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Source: Agilent Technologies Inc.
