{"entity":{"id":"oncomate-msi-dx","kind":"drug","name":"OncoMate MSI Dx Analysis System","aka":[],"tldr":"Promega's microsatellite instability test, approved twice: to find microsatellite-stable endometrial cancer for pembrolizumab with lenvatinib, and MSI-high solid tumours for pembrolizumab.","summary":"Promega's OncoMate MSI Dx Analysis System holds two FDA approvals. PMA P240026 (5 November 2025) makes it the companion diagnostic for pembrolizumab with lenvatinib in endometrial carcinoma that is microsatellite stable (not MSI-high). PMA P250046 (15 September 2026) makes it the companion diagnostic for pembrolizumab in MSI-high solid tumours. The same test can therefore open one treatment when the result is stable and another when it is high.","status":"approved","asOf":"2026-11-03","links":[{"label":"FDA PMA P240026","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240026"},{"label":"FDA PMA P250046","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250046"},{"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":["msi-high"],"cancers":["endometrial","metastatic-cancer"],"sections":[],"technologies":["companion-diagnostic"],"targets":[],"drugs":["pembrolizumab","lenvatinib"],"companies":["promega"],"institutions":[],"pathways":[],"terms":["msi","companion-diagnostic-term"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"OncoMate MSI Dx Analysis System","modality":"Nucleic acid companion diagnostic test (microsatellite instability, tumour tissue)","mechanism":"A nucleic acid test for microsatellite instability in tumour tissue (FDA generic name: nucleic acid based assay, microsatellite instability).","approvals":[{"region":"US","year":2025,"indication":"Companion diagnostic for pembrolizumab with lenvatinib in microsatellite-stable endometrial carcinoma"},{"region":"US","year":2026,"indication":"Companion diagnostic for pembrolizumab in MSI-high solid tumours"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/oncomate-msi-dx/","neighbours":{"biomarker":[{"id":"msi-high","kind":"biomarker","name":"MSI-high (microsatellite instability by PCR or sequencing)","route":"/biomarkers/msi-high/"}],"cancer":[{"id":"endometrial","kind":"cancer","name":"Endometrial cancer","route":"/cancers/endometrial/"},{"id":"metastatic-cancer","kind":"cancer","name":"Metastatic cancer (cancer that has spread)","route":"/cancers/metastatic-cancer/"}],"technology":[{"id":"companion-diagnostic","kind":"technology","name":"Companion diagnostics","route":"/technologies/companion-diagnostic/"}],"drug":[{"id":"lenvatinib","kind":"drug","name":"Lenvatinib","route":"/drugs/lenvatinib/"},{"id":"pembrolizumab","kind":"drug","name":"Pembrolizumab","route":"/drugs/pembrolizumab/"}],"company":[{"id":"promega","kind":"company","name":"Promega","route":"/companies/promega/"}],"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/"}]}}