Agilent Technologies Inc. announced that the U.S. Food and Drug Administration (FDA) has approved PD-L1 IHC 22C3 pharmDx, Code SK006, as the only FDA-approved companion diagnostic indicated to aid in identifying patients with epithelial ovarian, fallopian tube, or primary peritoneal carcinoma (EOC), whose tumors express PD-L1 and who may be eligible for treatment with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy.

PD-L1 IHC 22C3 pharmDx, Code SK006, enables pathologists to assess PD-L1 expression at the time of diagnosis, supporting informed treatment decisions in a disease where therapeutic options remain limited for many patients. This approval marks the seventh FDA approved companion diagnostic indication currently available for PD-L1 IHC 22C3 pharmDx, Code SK006, for use with KEYTRUDA.

Nina Green, vice president and general manager of Agilent’s Clinical Diagnostics Division, stated: “Delivering effective precision oncology requires close collaboration between diagnostics and therapeutics, and this FDA approval reflects Agilent’s long-standing industry partnership in companion diagnostics. We are proud to enable pathologists to identify patients with EOC who may benefit from immunotherapy. As the first immuno-oncology approval for this disease, this milestone underscores our commitment to advancing precision medicine and expanding access to innovative cancer treatments worldwide.”

PD-L1 expression in EOC was evaluated using PD-L1 IHC 22C3 pharmDx, Code SK006, in the KEYNOTE-B96 clinical trial supporting its use in identifying patients who may benefit from KEYTRUDA.

In the U.S., ovarian cancer caused approximately 12,730 deaths in 2025 and has a 5-year survival rate of 51.6% between 2015 to 2021³.

In addition to EOC, PD-L1 IHC 22C3 pharmDx, Code SK006, is indicated in the U.S. to help physicians identify patients with non-small cell lung cancer (NSCLC), esophageal squamous cell carcinoma (ESCC), cervical cancer, head and neck squamous cell carcinoma (HNSCC), triple-negative breast cancer (TNBC), and gastric or gastroesophageal junction (GEJ) adenocarcinoma who may benefit from treatment with KEYTRUDA.

PD-L1 IHC 22C3 pharmDx, Code SK006, was developed by Agilent in partnership with Merck & Co. (known as MSD outside the United States and Canada) as a companion diagnostic for KEYTRUDA.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

Corrected on Feb. 11, 2026: Amended press release to align with FDA-approved KEYTRUDA indication language. See KEYTRUDA full prescribing information.