Agilent’s MMR IHC Panel pharmDx (Dako Omnis) Receives European IVDR Certification as a Companion Diagnostic Test for Colorectal Cancer

SANTA CLARA, Calif.--(BUSINESS WIRE)--Agilent Technologies Inc. (NYSE: A) today announced 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. 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.

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.

1. In Vitro Diagnostic Medical Devices Regulation (europa.eu)
2. Olave, M.C.; Graham, R.P. Mismatch repair deficiency: The what, how, and why it is important. Genes Chromosomes Cancer 2022, 61 (6), 314-321. DOI:10.1002/gcc.23015.
3. Mulet-Margalef, N.; Linares, J.; Badia-Ramentol, J.; Jimeno, M.; Sanz Monte, C.; Manzano Mozo, J.L.; Calon, A. Challenges and Therapeutic Opportunities in the dMMR/MSI-H Colorectal Cancer Landscape. Cancers 2023, 15 (4), 1022. DOI: 10.3390/cancers15041022. PMID: 36831367; PMCID: PMC9954007.

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