On September 2, 2025 Agilent Technologies Inc. (NYSE: A) reported that its MMR IHC Panel pharmDx (Dako Omnis) has received class C companion diagnostic (CDx) certification under EU in vitro diagnostic regulation (IVDR)1 as a CDx test for colorectal cancer (Press release, Agilent, SEP 2, 2025, View Source [SID1234655681]). MMR IHC Panel pharmDx (Dako Omnis) is indicated as an aid to identify mismatch repair (MMR) deficient CRC patients eligible for treatment with OPDIVO (nivolumab) in combination with YERVOY (ipilimumab). MMR IHC Panel pharmDx (Dako Omnis) is approved for exclusive use with the Agilent Dako Omnis automated staining solution.

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The MMR pathway corrects DNA replication errors to maintain genomic stability2. Dysfunction in key MMR proteins (MLH1, PMS2, MSH2, and MSH6) causes MMR deficiency (dMMR), leading to elevated mutations, tumorigenesis, and neoantigen accumulation—features that make dMMR tumors more responsive to immunotherapy due to enhanced immune recognition3.

MMR IHC Panel pharmDx (Dako Omnis) is an immunohistochemical panel specifically developed and validated to detect the loss of function of any of the four MMR proteins in formalin-fixed paraffin-embedded colorectal cancer tissue. Agilent’s panel is the only companion diagnostic IHC panel IVDR approved to diagnose colorectal cancer patients eligible for treatment with OPDIVO in combination with YERVOY.

Nina Green, vice-president and general manager of Agilent’s Clinical Diagnostics Division remarked: "The approval of MMR IHC Panel pharmDx will provide physicians in Europe with critical information to inform treatment decisions for patients with mismatch repair deficiency (dMMR). This endorsement underscores Agilent’s leadership in the development of companion diagnostics for groundbreaking therapies."

Agilent collaborated with Bristol Myers Squibb Company to develop the MMR IHC Panel pharmDx (Dako Omnis).

OPDIVO and YERVOY are registered trademarks of Bristol-Myers Squibb Company.