Agilent gets FDA approval for cancer diagnostic test

Agilent Technologies Inc. (A) received U.S. Food and Drug Administration approval for its PD-L1 IHC 22C3 pharmDx diagnostic test to identify patients with esophageal or gastroesophageal junction carcinoma who may be eligible for treatment with Merck’s KEYTRUDA (pembrolizumab).

The diagnostic test identifies patients whose tumors express PD-L1 with a Combined Positive Score of 1 or higher. This marks the eighth FDA-approved companion diagnostic indication for the PD-L1 IHC 22C3 pharmDx test for use with KEYTRUDA.

The test is designed to help physicians identify patients with locally advanced or metastatic esophageal or gastroesophageal junction carcinoma that cannot be treated with surgical resection or definitive chemoradiation. KEYTRUDA is indicated for these patients in combination with platinum- and fluoropyrimidine-based chemotherapy when tumors express PD-L1.

The diagnostic is also approved for use in identifying patients with non-small cell lung cancer, esophageal squamous cell carcinoma, cervical cancer, head and neck squamous cell carcinoma, triple-negative breast cancer, gastric or gastroesophageal junction adenocarcinoma, and epithelial ovarian, fallopian tube, or primary peritoneal carcinoma who may benefit from KEYTRUDA treatment.

According to the National Cancer Institute, esophageal cancer caused approximately 16,250 deaths in the United States in 2025, with a 5-year relative survival rate of 21.9 percent.

Agilent developed the diagnostic test in partnership with Merck as a companion diagnostic for KEYTRUDA. The information is based on a company press release.