No image
OncoMate MSI Dx Analysis System
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.
Details
Device typeMicrosatellite instability IVD, kit, nucleic acid technique (NAT): A collection of reagents and other associated materials intended to be used for determining microsatellite instability [abnormal repeated sequences of deoxyribonucleic acid (DNA)] within a tumour tissue specimen, using a nucleic acid technique (NAT). This phenomenon which is associated with defective DNA mismatch repair genes is a feature of certain cancer types including hereditary nonpolyposis colon cancer (HNPCC).
FDA categoryLynch Syndrome Test System, Nucleic Acid Based Assay, Microsatellite Instability
Device ID00849811031717
Catalog numberMD2140
AvailabilityPrescription
MRI safetyLabeling does not contain MRI Safety Information