Intended Use Statement: The OncoMate® MSI Dx Analysis System is a qualitative multiplex polymerase chain reaction (PCR) test intended to detect the deletion of mononucleotides in 5 microsatellite loci (BAT-25, BAT-26, NR-21, NR-24 and MONO-27) using matched tumor and normal DNA obtained from formalin fixed paraffin-embedded (FFPE) colorectal tissue sections. The OncoMate® MSI Dx Analysis System is for use with the Applied Biosystems® 3500Dx Genetic Analyzer and OncoMate® MSI Dx Interpretive Software.
The OncoMate® MSI Dx Analysis System is indicated in patients diagnosed with colorectal cancer (CRC) to detect microsatellite instability (MSI) as an aid in the identification of probable Lynch syndrome to help identify patients that would benefit from additional genetic testing to diagnose Lynch syndrome.
Results from the OncoMate® MSI Dx Analysis System should be interpreted by healthcare professionals in conjunction with other clinical findings, family history and other laboratory data.
The clinical performance of this device to guide treatment decision for MSI high patients has not been established.