Therapy Areas: Oncology
Agilent's MMR IHC Panel gains FDA approval as colorectal cancer companion diagnostic test
20 August 2025 -

Agilent Technologies Inc (NYSE: A), a provider of analytical and clinical laboratory technologies, announced on Wednesday that it has received FDA approval for its MMR IHC Panel pharmDx (Dako Omnis) as a companion diagnostic for colorectal cancer. The test identifies mismatch repair deficient (dMMR) patients eligible for treatment with Bristol Myers Squibb's Opdivo (nivolumab) alone or combined with Yervoy (ipilimumab).

Designed for use exclusively with Agilent's Dako Omnis automated staining system, the panel detects loss of function in key MMR proteins (MLH1, PMS2, MSH2, MSH6) in formalin-fixed paraffin-embedded colorectal cancer tissue. It is the only FDA-approved IHC companion diagnostic for selecting CRC patients for Opdivo-based therapy.

Development of the panel involved collaboration between Agilent and Bristol Myers Squibb, underscoring joint efforts to advance precision diagnostics and targeted treatment selection.

Agilent Technologies reported USD6.51bn in revenue for fiscal year 2024 and employs approximately 18,000 staff worldwide.

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