# MMR IHC Panel pharmDx (Dako Omnis)

Source: https://onco.cc/drugs/mmr-ihc-panel-pharmdx/  
OnCo record `mmr-ihc-panel-pharmdx` (Test). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Agilent's four-protein mismatch repair stain, approved in 2025 to select nivolumab, with or without ipilimumab, in bowel cancer.

## Summary

Agilent's MMR IHC Panel pharmDx (Dako Omnis) was approved on 15 August 2025 (PMA P250004) as the companion diagnostic for nivolumab, alone or with ipilimumab, in colorectal cancer with deficient mismatch repair. Roche's VENTANA MMR RxDx Panel stains the same four proteins and carries other drug claims.

## Fields

- Kind: Test
- Status: approved
- Last checked: 2026-11-03
- Tags: test
- Brand: MMR IHC Panel pharmDx
- Modality: Immunohistochemistry companion diagnostic panel (mismatch repair proteins, colorectal tumour tissue)
- Mechanism: Immunohistochemistry for the four mismatch repair proteins MLH1, PMS2, MSH2 and MSH6 on the Dako Omnis platform; loss of any one marks the tumour as mismatch repair deficient (dMMR).
- Approvals: US 2025: Companion diagnostic for nivolumab alone or with ipilimumab in dMMR colorectal cancer

## Sources

- FDA PMA P250004: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250004
- FDA: List of cleared or approved companion diagnostic devices: https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools

## Connected records

- drugs: [Idylla CDx MSI Test](https://onco.cc/drugs/idylla-cdx-msi/), [Ipilimumab](https://onco.cc/drugs/ipilimumab/), [Nivolumab](https://onco.cc/drugs/nivolumab/), [VENTANA MMR RxDx Panel](https://onco.cc/drugs/ventana-mmr-rxdx/)
- biomarkers: [dMMR (mismatch repair deficiency by IHC)](https://onco.cc/biomarkers/dmmr-ihc/)
- cancers: [Colorectal cancer](https://onco.cc/cancers/colorectal/)
- technologies: [Companion diagnostics](https://onco.cc/technologies/companion-diagnostic/), [Histopathology & immunohistochemistry](https://onco.cc/technologies/histopathology-ihc/)
- targets: [Mismatch repair proteins (MLH1, MSH2, MSH6, PMS2)](https://onco.cc/targets/mmr/)
- companies: [Agilent Technologies (Dako)](https://onco.cc/companies/agilent/)
- terms: [Companion diagnostic](https://onco.cc/terms/companion-diagnostic-term/), [Immunohistochemistry (IHC)](https://onco.cc/terms/ihc/), [Microsatellite instability (MSI-H) / mismatch repair deficiency (dMMR)](https://onco.cc/terms/msi/)

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