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Agilent's diagnostic test gets FDA nod for use in cervical cancer

Agilent Technologies Inc.'s diagnostic test received approval from the U.S. Food and Drug Administration for use in cervical cancer.

The test, Dako PD-L1 IHC 22C3 pharmDx, has an initial approval in non-small cell lung cancer and a subsequent expanded approval for stomach cancer.

The in vitro diagnostic test — done on samples such as blood or tissue — helps to check whether cancer cells have the PD-L1 protein and allows healthcare professionals to identify patients who are most likely to benefit from treatment with anti-PD-1 immunotherapy, such as Merck & Co. Inc.'s Keytruda.

Keytruda, or pembrolizumab, works by blocking the PD-1 protein on immune cells from linking up with the PD-L1 protein on cancer cells and has generally been limited to patients with high levels of the PD-L1 marker. The therapy was recently approved for cervical cancer.

"PD-L1 is a critical biomarker for identifying patients who are likely to derive benefit from anti-PD-1 immunotherapy, and with an increasingly complex marketplace, pathologists look to Agilent as the clear leader to provide accurate and reliable PD-L1 testing," said Sam Raha, president of Agilent's Diagnostics and Genomics Group.