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| Device | OncoMate® MSI Dx Analysis System |
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| Generic Name | Nucleic Acid Based Assay, Microsatellite Instability |
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| Applicant | Promega Corporation
2800 Woods Hollow Rd.
Madison, WI 53711 |
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| PMA Number | P240026 |
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| Date Received | 07/26/2024 |
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| Decision Date | 11/05/2025 |
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| Product Code |
SFL |
| Docket Number | FDA-6100 |
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| Notice Date | 11/24/2025 |
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| Advisory Committee |
Molecular Genetics |
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| Clinical Trials | NCT03517449
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Predetermined Change Control Plan Authorized | No |
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Approval Order Statement
Approval for the OncoMate® MSI Dx Analysis System. The OncoMate® MSI Dx Analysis System is a qualitative multiplex polymerase chain reaction (PCR) test intended to detect the deletion of mononucleotides in five microsatellite loci (BAT-25, BAT-26, NR-21, NR-24 and MONO-27) for the identification of microsatellite instability (MSI) using DNA obtained from formalin-fixed, paraffin-embedded (FFPE) endometrial carcinoma tissue specimens, and DNA isolated from matched normal FFPE specimen or whole blood. The OncoMate® MSI Dx Analysis System is for use with the Applied Biosystems® 3500 Dx Genetic Analyzer and OncoMate® MSI Dx Analysis Software.The OncoMate® MSI Dx Analysis System is indicated for use as a companion diagnostic test to identify patients with microsatellite stable (MSS; defined as not MSI-high [not MSI-H]) endometrial carcinoma who may benefit from treatment with KEYTRUDA® (pembrolizumab) in combination with LENVIMA® (lenvatinib) in accordance with the approved therapeutic product labeling. |
| Approval Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling |
Labeling Part 2 |
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