Agilent MMR IHC Panel pharmDx (Dako Omnis) Receives FDA Approval 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 FDA approval as a companion diagnostic (CDx) test for colorectal cancer. This test aids in identifying mismatch repair deficient (dMMR) colorectal cancer (CRC) patients who are eligible for treatment with Bristol Myers Squibb’s Opdivo^® (nivolumab) alone or Opdivo (nivolumab) in combination with Yervoy^® (ipilimumab). The MMR IHC Panel pharmDx (Dako Omnis) is approved for exclusive use with the Agilent Dako Omnis automated staining solution.

The mismatch repair (MMR) pathway corrects DNA replication errors to maintain genomic stability¹. Dysfunction in key MMR proteins (MLH1, PMS2, MSH2, and MSH6) causes MMR deficiency, leading to elevated mutations, tumorigenesis, and neoantigen accumulation—features that make dMMR tumors more responsive to immunotherapy due to enhanced immune recognition².

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

“This approval marks an important step forward in the ongoing effort to improve colorectal cancer care,” stated Nina Green, vice-president and general manager of Agilent’s Clinical Diagnostics Division. “Our new CDx product offers healthcare providers an additional tool to identify mismatch repair deficiency in patients, complementing existing options and enhancing the ability to tailor immunotherapy treatments. By providing more choices, we aim to support better tumor control and potentially improve progression-free survival, ultimately contributing to patient care and well-being.”

Agilent partnered with Bristol Myers Squibb to develop the MMR IHC Panel pharmDx (Dako Omnis). This highlights the collaborative efforts between Agilent and Bristol Myers Squibb in developing and gaining approval for diagnostic assays that aid in selecting patients for specific treatments.

Opdivo® and Yervoy® are registered trademarks of Bristol-Myers Squibb Company.

1. 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.
2. 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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