{"entity":{"id":"idylla-cdx-msi","kind":"drug","name":"Idylla CDx MSI Test","aka":[],"tldr":"A test that finds MSI-high bowel cancer, the group that can be treated with nivolumab alone or with ipilimumab.","summary":"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.","status":"approved","asOf":"2026-11-03","links":[{"label":"FDA PMA P250005","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250005"},{"label":"FDA: List of cleared or approved companion diagnostic devices","url":"https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools"}],"tags":["test"],"related":["mmr-ihc-panel-pharmdx","msi-high"],"cancers":["colorectal"],"sections":[],"technologies":["companion-diagnostic"],"targets":[],"drugs":["nivolumab","ipilimumab"],"companies":["biocartis"],"institutions":[],"pathways":[],"terms":["msi","companion-diagnostic-term"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Idylla CDx MSI Test","modality":"Nucleic acid companion diagnostic test (microsatellite instability, colorectal tumour tissue)","mechanism":"Reads seven microsatellite markers (ACVR2A, BTBD7, DIDO1, MRE11, RYR3, SEC31A and SULF2) in colorectal tumour tissue to call microsatellite instability-high (MSI-H).","approvals":[{"region":"US","year":2025,"indication":"Companion diagnostic for nivolumab alone or with ipilimumab in MSI-H colorectal cancer"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/idylla-cdx-msi/","neighbours":{"drug":[{"id":"ipilimumab","kind":"drug","name":"Ipilimumab","route":"/drugs/ipilimumab/"},{"id":"mmr-ihc-panel-pharmdx","kind":"drug","name":"MMR IHC Panel pharmDx (Dako Omnis)","route":"/drugs/mmr-ihc-panel-pharmdx/"},{"id":"nivolumab","kind":"drug","name":"Nivolumab","route":"/drugs/nivolumab/"}],"biomarker":[{"id":"msi-high","kind":"biomarker","name":"MSI-high (microsatellite instability by PCR or sequencing)","route":"/biomarkers/msi-high/"}],"cancer":[{"id":"colorectal","kind":"cancer","name":"Colorectal cancer","route":"/cancers/colorectal/"}],"technology":[{"id":"companion-diagnostic","kind":"technology","name":"Companion diagnostics","route":"/technologies/companion-diagnostic/"}],"company":[{"id":"biocartis","kind":"company","name":"Biocartis","route":"/companies/biocartis/"}],"term":[{"id":"companion-diagnostic-term","kind":"term","name":"Companion diagnostic","route":"/terms/companion-diagnostic-term/"},{"id":"msi","kind":"term","name":"Microsatellite instability (MSI-H) / mismatch repair deficiency (dMMR)","route":"/terms/msi/"}]}}