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Agilent Technologies PD-L1 IHC Assay Approved by China Regulators

NEW YORK – The China National Medical Products Administration (NMPA) has approved Agilent Technologies' PD-L1 IHC 22C3 pharmaDx assay for marketing in that country, the company said today.

Santa Clara, California-based Agilent said that the assay is now approved as a companion diagnostic to identify patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with tumors that express PD-L1 for first-line treatment with Merck's anti-PD-L1 immunotherapy pembrolizumab (Keytruda).

Merck and Agilent's Dako subsidiary developed the assay in partnership, and the US Food and Drug administration initially approved the test in Oct. 2015 to determine whether patients with advanced NSCLC were likely to respond to Keytruda. In August, Agilent received expanded approval from the FDA for the assay to be used as a companion diagnostic for Keytruda for esophageal squamous cell carcinoma.

"Pathologists in China recognize the need for validated tests, and our companion diagnostic gives them a highly accurate tool to inform oncologists on PD-L1 expression for metastatic NSCLC patients," Sam Raha, president of Agilent's Diagnostics and Genomics Group, said in a statement. "With this approval, Agilent is excited to be able to offer the first PD-L1 CDx in the Chinese market."