CE-Marked IVD Medical Device for Microsatellite Instability Status
- PCR-based fragment-sizing test used to determine microsatellite instability (MSI) status
- Uses DNA purified from a single FFPE section with ≥ 20% tumor content
- MSI determination with strong agreement with IHC (PPA 97.3%, NPA 97.2%)
Accurately Determine the MSI Status of Tumors Using the Gold Standard Method
The OncoMate™ MSI Dx Analysis System is a fluorescent, multiplex PCR-based test to detect microsatellite instability (MSI). MSI is a form of genomic instability caused by the insertion or deletion of repeating bases called microsatellites during DNA replication due to the failure of the mismatch repair system (MMR) to correct these errors.
Sensitive Panel of Mononucleotide Repeat Markers
The OncoMate™ MSI Dx Analysis System targets five mononucleotide repeat markers (BAT-25, BAT-26, NR-21, NR-24 and MONO-27) that were selected for high sensitivity and specificity to alterations in repeat lengths in samples containing mismatch repair defects1,2. For quality control for sample authentication of matched tumor and normal samples, the system uses two pentanucleotide repeat markers (Penta C and Penta D) that were selected for their high level of polymorphism and lower degree of MSI.
1Bacher, J. et al. (2004) Dis. Markers 20, 237.
2Luchini C., et al. (2019) Annals of Oncology. 30, 123
Be Efficient with Your Precious Samples
The OncoMate™ MSI Dx Analysis System provides an MSI result with ≤1 FFPE section. A tumor sample with ≥20% tumor content can provide a valid result with the system. In a retrospective study of colorectal cancers, the OncoMate™ MSI Dx Analysis System showed concordance with immunohistochemistry and is approved to help identify patients that may benefit from further diagnostic testing.
Intended Use Statement: The OncoMate™ MSI Dx Analysis System is a PCR-based fragment-sizing test used to determine microsatellite instability (MSI) status in DNA purified from human formalin-fixed paraffin-embedded (FFPE) tissue samples derived from solid tumors.
The OncoMate™ MSI Dx Analysis System generates allelic profiles from tumor and non-tumor FFPE tissue samples from the same patient through polymerase chain reaction (PCR) amplification of DNA microsatellite markers, followed by size separation of the amplified markers using capillary electrophoresis. MSI status is determined by comparing the allelic profiles. An expansion or reduction in the length of repetitive DNA sequences in the tumor cell DNA when compared to the normal cell DNA from the same patient indicates MSI. Normal and tumor tissue from the same patient must be tested at the same time and data from both samples must be available for comparison for results to be valid.
The OncoMate™ MSI Dx Analysis System is not intended to diagnose a specific disease. It is intended for use with patients already diagnosed with cancer who may benefit from additional genetic testing. Test results obtained using the product must be interpreted by healthcare professionals in conjunction with other clinical findings, family history and laboratory data. This product is intended for professional use only.