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    Agilent has developed MMR IHC Panel pharmDx (Dako Omnis) for use as a companion diagnostic to aid in identifying dMMR colorectal cancer (CRC) patients who may benefit from immunotherapy. MMR IHC Panel pharmDx (Dako Omnis) is used with the EnVision FLEX visualization system as an automated immunohistochemistry (IHC) assay on the Dako Omnis instrument. The absence of IHC staining in any of the MMR proteins of MMR IHC Panel pharmDx (Dako Omnis) indicates a diagnostic status of dMMR for the patient case.
    Cancer:
    Colorectal Cancer
    Gene:
    MLH1 (MutL homolog 1), MSH2 (MutS Homolog 2), MSH6 (MutS homolog 6), PMS2 (PMS1 protein homolog 2)
    Drug:
    Opdivo (nivolumab), Yervoy (ipilimumab)
    Method:
    Immunohistochemistry (IHC)
    Approvals
    Date
    Cancer
    Gene
    Drug
    By
    08/21/25
    CRC
    PMS2
    nivolumab +
    ipilimumab
    FDA (PMA)
    MSH6
    MSH2
    MLH1
    09/02/25
    CRC
    PMS2
    nivolumab +
    ipilimumab
    CE-IVDR (New IVDR)
    MSH6
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