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Agilent Technologies Inc., a global leader in analytical and clinical laboratory technologies, announced that the US 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 tumours 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 US, ovarian cancer caused approximately 12,730 deaths in 2025 and has a 5-year survival rate of 51.6% between 2015 to 2021.
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.
Agilent Technologies, Inc. is a global leader in analytical and clinical laboratory technologies, delivering insights and innovation that help our customers bring great science to life. Agilent’s full range of solutions includes instruments, software, services, and expertise that provide trusted answers to our customers' most challenging questions.
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