FDA approves first immunotherapy-linked test to guide ovarian cancer care

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Agilent Technologies announced that the U.S. FDA has approved its PD-L1 IHC 22C3 pharmDx, Code SK006, as a companion diagnostic for first-line epithelial ovarian, fallopian tube, or primary peritoneal carcinoma (EOC). This test identifies patients whose tumors express PD-L1 and may be eligible for treatment with Merck’s KEYTRUDA® (pembrolizumab). This approval marks the seventh FDA-approved companion diagnostic indication for the test, expanding treatment options for EOC, a disease with a challenging prognosis.

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