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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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DeviceMMR IHC Panel pharmDx (Dako Omnis)
Generic NameImmunohistochemistry test, DNA mismatch repair (MMR) Protein assay
Regulation Number864.1860
ApplicantAgilent Technologies, Inc.
6392 Via Real
Carpinteria, CA 93013
PMA NumberP250004
Date Received02/18/2025
Decision Date08/15/2025
Product Code QNH 
Advisory Committee Pathology
Clinical TrialsNCT04008030
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
For In Vitro Diagnostic Use.MMR IHC Panel pharmDx (Dako Omnis) is a qualitative immunohistochemical (IHC) assay intended for use in the assessment of mismatch repair (MMR) proteins (MLH1, PMS2, MSH2, and MSH6) in formalin-fixed, paraffin-embedded (FFPE) colorectal cancer (CRC) tissue using EnVision FLEX visualization system on Dako Omnis automated staining instrument. MMR IHC Panel pharmDx (Dako Omnis) consists of MLH1 IHC pharmDx (Dako Omnis), PMS2 IHC pharmDx (Dako Omnis), MSH2 IHC pharmDx (Dako Omnis), and MSH6 IHC pharmDx (Dako Omnis), which must be used together to identify MMR deficient CRC patients.MMR IHC Panel pharmDx (Dako Omnis) is indicated as an aid to identify MMR deficient CRC patients eligible for treatment with OPDIVO® (nivolumab) alone or OPDIVO (nivolumab) in combination with YERVOY® (ipilimumab).
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
Labeling
Labeling Part 2
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