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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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DeviceOncoMate® MSI Dx Analysis System
Generic NameNucleic Acid Based Assay, Microsatellite Instability
ApplicantPromega Corporation
2800 Woods Hollow Rd.
Madison, WI 53711
PMA NumberP250046
Date Received11/14/2025
Decision Date09/15/2026
Product Code SFL 
Advisory Committee Molecular Genetics
Clinical TrialsNCT02054806
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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) using DNA obtained from formalin-fixed, paraffin-embedded (FFPE) solid tumor tissue. The assay requires DNA from a matched normal specimen of the same individual, which may be obtained from FFPE tissue 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 intended for use as a companion diagnostic to identify MSI-H patients with advanced solid tumor cancers eligible for treatment with KEYTRUDA® in accordance with the approved therapeutic product labeling.
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