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Agilent Cancer Diagnostic Assay Receives Certification to Comply with New EU Regulations
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Agilent Cancer Diagnostic Assay Receives Certification to Comply with New EU Regulations
Dec 10, 2024 9:40 AM

12:10 PM EST, 12/10/2024 (MT Newswires) -- Agilent Technologies ( A ) Tuesday said European regulators have issued a class C in vitro diagnostic regulation certification for the company's PD-L1 IHC 28-8 pharmDx diagnostic assay.

The companion diagnostic identifies the PD-L1 biomarker and the body's potential response to cancer therapies such as Bristol-Myers Squibb's (BMY) Opdivo that contain anti-PD-1 antibodies and have shown therapeutic value across a variety of cancer types.

The Agilent ( A ) assay previously carried a CE-IVD mark for sales in the European Union and is now certified to comply with new EU regulations for in vitro diagnostic medical devices, the company said.

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