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    The Idylla™ CDx MSI Test is an FDA-approved (PMA P250005), fully automated, qualitative in vitro diagnostic real-time PCR assay designed for use on the Idylla™ Platform. It is a companion diagnostic that detects microsatellite instability (MSI) status in formalin-fixed, paraffin-embedded (FFPE) colorectal cancer (CRC) tissue samples to identify patients eligible for treatment with nivolumab (OPDIVO®) alone or in combination with ipilimumab (YERVOY®).
    Cancer:
    Colorectal Cancer
    Gene:
    MSI (Microsatellite instability)
    Drug:
    Opdivo (nivolumab), Yervoy (ipilimumab)
    Method:
    PCR
    Approvals
    Date
    Cancer
    Gene
    Drug
    By
    08/15/25
    CRC
    MSI
    nivolumab +
    ipilimumab
    FDA (PMA)
    03/10/26
    CRC
    MSI
    nivolumab +
    ipilimumab
    CE-IVDR (New IVDR)