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Promega's microsatellite instability test, approved twice: to find microsatellite-stable endometrial cancer for pembrolizumab with lenvatinib, and MSI-high solid tumours for pembrolizumab.
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.
A nucleic acid test for microsatellite instability in tumour tissue (FDA generic name: nucleic acid based assay, microsatellite instability).
| Region | Year | Indication |
|---|---|---|
| US | 2025 | Companion diagnostic for pembrolizumab with lenvatinib in microsatellite-stable endometrial carcinoma |
| US | 2026 | Companion diagnostic for pembrolizumab in MSI-high solid tumours |
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Query for this drug: (TITLE:"OncoMate MSI Dx Analysis System" OR ABSTRACT:"OncoMate MSI Dx Analysis System") 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 OncoMate MSI Dx Analysis System, 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 MSI-high (microsatellite instability by PCR or sequencing), Microsatellite instability (MSI-H) / mismatch repair deficiency (dMMR), Metastatic cancer (cancer that has spread) and the tag test.
Shares Companion diagnostic, Companion diagnostics, Microsatellite instability (MSI-H) / mismatch repair deficiency (dMMR) and the tag test.
Shares MSI-high (microsatellite instability by PCR or sequencing), Microsatellite instability (MSI-H) / mismatch repair deficiency (dMMR), Metastatic cancer (cancer that has spread) and the tag test.
Shares MSI-high (microsatellite instability by PCR or sequencing), Microsatellite instability (MSI-H) / mismatch repair deficiency (dMMR), Metastatic cancer (cancer that has spread) and the tag test.
Shares MSI-high (microsatellite instability by PCR or sequencing), Microsatellite instability (MSI-H) / mismatch repair deficiency (dMMR), Metastatic cancer (cancer that has spread) 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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