OncoMate™ MSI Dx Analysis System Technical Manual
Instructions for Use of Product(s)
MD3140
Literature # TM595
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). The complete workflow surrounding use of the OncoMate™ MSI Dx Analysis System 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.
This product is only available in France, Germany, Austria, Poland, UK, Ireland, Belgium, Netherlands, Luxembourg, Spain, Italy, Switzerland, Denmark, Sweden, Norway, Czech Republic, Hungary, Romania and Slovakia.
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