The OncoMate™ MSI Dx Analysis System is a CE-marked IVD medical device that uses a fluorescent PCR-based assay as part of a broader laboratory workflow to analyze formalin-fixed, paraffin-embedded (FFPE) tissue samples for microsatellite instability (MSI). It involves DNA extraction from FFPE tissue sample, quantification of DNA, amplification of specific microsatellite markers via multiplex PCR, analysis of amplified DNA fragments by capillary electrophoresis and analysis of capillary electrophoresis fragment data using a fragment analysis software.