Agilent Receives MFDS Approval in South Korea for Companion Diagnostic PD-L1 IHC 22C3 pharmDx

New approval demonstrates confidence in companion diagnostic advancing immunotherapy options for non-small cell lung cancer patients.




SEOUL, South Korea--(BUSINESS WIRE)-- Agilent Technologies Inc. (NYSE: A) today announced that the South Korea Ministry of Food and Drug Safety (MFDS) has approved the company’s 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.


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.

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.



“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,” said Sam Raha, president of Agilent’s Diagnostics and Genomics Group. “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 in areas of unmet need.”


“At Agilent, we are pleased to build on our strong heritage of bringing innovative technologies to patients with NSCLC and the laboratories across South Korea,” said You Jae Soo, South Korea country general manager of Agilent. “This important milestone reflects the company’s position as a trusted local provider of diagnostic assays that deliver high-quality answers.”


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.


Lung cancer remained the leading cause of cancer-related deaths in South Korea, with an estimated 20,505 deaths and 28,651 new cases reported in 2020¹. Globally, NSCLC accounts for approximately 85% of lung cancer diagnoses, resulting in nearly 1.7 million new cases each year².


1. International Agency for Research on Cancer – South Korea Cancer Stat.

https://gco.iarc.fr/today/data/factsheets/populations/410-korea-republic-of-fact-sheets.pdf (accessed on May 23, 2022).


2. World Health Organization – Cancer Stat. https://www.who.int/news-room/fact sheets/detail/cancer (accessed May 23, 2022).


About Agilent Technologies

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