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FDA Approves Expanded Use of Agilent Assay as Keytruda CDx for Cervical Cancer

NEW YORK (GenomeWeb) – Agilent Technologies said after the close of the market on Tuesday that the US Food and Drug Administration has approved the Dako PD-L1 IHC 22C3 pharmDx assay for expanded use as a companion diagnostic test for Keytruda (pembrolizumab) for cervical cancer.

The test can now be used by physicians to identify cervical cancer patients who may benefit from the anti-PD1 immunotherapy from Merck. The two companies developed the Dako assay in partnership, and the FDA initially approved PD-L1 IHC 22C3 pharmDx as a companion diagnostic for Keytruda for non-small cell lung cancer in October 2015. A year later, the agency granted expanded approval for the assay as a CDx for Keytruda to determine expression status and inform treatment in a broader range of metastatic NSCLC patients. Last September, the FDA expanded approval for the assay as a CDx for the drug for gastric or gastroesophageal junction adenocarcinoma.

Agilent said that about 13,000 new cases of cervical cancer are expected to be diagnosed this year, making it the third most common gynecological cancer in the US. Despite advances in prevention and early detection, the overall survival rate has not improved in the past 40 years, the company added.