South Korea Ministry of Food and Drug Safety (MFDS) has approved the Agilent Technologies PD-L1 IHC 22C3 pharmDx as a companion diagnostic (CDx) to identify patients with non-small cell lung cancer (NSCLC) who are suitable for first-line monotherapy with KEYTRUDA (pembrolizumab) on the Dako Omnis platform.

Dako Omnis is Agilent’s fully automated solution for staining tumor samples that supports lean and flexible workflows integrated into the core of the laboratory interface, providing diagnostic confidence for the right NSCLC patients to facilitate greater choice and accelerate patient care.

This marks the third approval of the CDx for Agilent in the context of treatment with KEYTRUDA to enable metastatic NSCLC patients’ access to targeted immunotherapy for improved patient outcomes.

KEYTRUDA is a humanized anti-PD-1 treatment indicated for cancer immunotherapy to help the immune system detect and fight tumor cells. Developed by Merck, KEYTRUDA blocks the PD-1 pathway to help prevent cancer cells from evading T cells. 

“The new approval in the Asia Pacific region reinforces the proven efficacy of this IHC-based companion diagnostic test for cancer therapy and enables further immunotherapy options for NSCLC patients, who previously had few and inefficient therapy options. We are committed to bringing PD-L1 IHC 22C3 pharmDx on Dako Omnis to the patient community as part of our plan to expand NSCLC detection” said Sam Raha, president of Agilent’s Diagnostics and Genomics Group.