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A test that finds MSI-high bowel cancer, the group that can be treated with nivolumab alone or with ipilimumab.
Biocartis's Idylla CDx MSI Test was approved on 15 August 2025 (PMA P250005) as the companion diagnostic for nivolumab, alone or with ipilimumab, in microsatellite instability-high colorectal cancer. The same day the FDA approved Agilent's MMR IHC Panel pharmDx for the same drugs, which reaches the same group by staining the mismatch repair proteins instead.
Reads seven microsatellite markers (ACVR2A, BTBD7, DIDO1, MRE11, RYR3, SEC31A and SULF2) in colorectal tumour tissue to call microsatellite instability-high (MSI-H).
| Region | Year | Indication |
|---|---|---|
| US | 2025 | Companion diagnostic for nivolumab alone or with ipilimumab in MSI-H colorectal cancer |
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Query for this drug: (TITLE:"Idylla CDx MSI Test" OR ABSTRACT:"Idylla CDx MSI Test") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Idylla CDx MSI Test, not a curated reading list.
Shares Companion diagnostic, MSI-high (microsatellite instability by PCR or sequencing), Companion diagnostics, Microsatellite instability (MSI-H) / mismatch repair deficiency (dMMR) and the tag test.
Shares Companion diagnostic, Companion diagnostics, Colorectal cancer and the tag test.
Shares Companion diagnostic, Companion diagnostics, Colorectal cancer and the tag test.
Shares MMR IHC Panel pharmDx (Dako Omnis), Companion diagnostics, Microsatellite instability (MSI-H) / mismatch repair deficiency (dMMR), Colorectal cancer and the tag test.
Shares Companion diagnostic, Companion diagnostics and the tag test.
Shares Companion diagnostic, Companion diagnostics and the tag test.
Shares Companion diagnostic, Companion diagnostics and the tag test.
Shares Companion diagnostic, Companion diagnostics and the tag test.
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