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.
