OncoMate® MSI Dx Interpretive Software

Accurate and Sensitive Automated MSI Data Interpretation

The OncoMate® MSI Dx Interpretive Software provides an accurate automated MSI result with minimal expertise. Raw data generated with the OncoMate® MSI Dx Analysis System is imported into the software, where it is evaluated for data quality, and an automated MSI result is determined. In a study of 154 colorectal cancer cases the OncoMate® MSI Dx Analysis System, in conjunction with the OncoMate® MSI Dx Interpretive Software, generated an MSI determination with a 97.8% positive percent agreement and a 97.2% negative percent agreement with MMR by IHC¹.

The FDA-cleared OncoMate® MSI Dx Interpretive Software (Cat.# MD4140) is available in the United States only. For information about availability in other regions, please contact us.

Accurately Determine the MSI Status of Colorectal Cancers Using the Gold Standard Method

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.

The OncoMate® MSI Dx Analysis System is a fluorescent, multiplex PCR-based test intended to detect the deletion of mononucleotides in five microsatellite loci (BAT-25, BAT-26, NR-21, NR-24 and MONO-27). The system is indicated in patients diagnosed with colorectal cancer (CRC) to detect microsatellite instability (MSI) as an aid in identification of probable Lynch syndrome to help identify patients that would benefit from additional genetic testing to diagnose Lynch syndrome.

Tumor to Answer Overnight

The OncoMate® MSI Dx Interpretive Software is part of a broader workflow that includes DNA extraction from FFPE tissue samples, quantitation of DNA, amplification of specific microsatellite markers using multiplex PCR, fragment separation by capillary electrophoresis, and data analysis and interpretation.

Illustration of a Maxwell CSC Instrument for DNA Isolation

Isolate DNA

from FFPE samples using the Maxwell® CSC DNA FFPE Kit and the Maxwell® CSC Instrument

Quantitate DNA

using fluorescent DNA quantitation reagents (e.g., QuantiFluor® Dx dsDNA System) and instruments

Illustration of a PCR amplification tube and pipette tip

Amplify DNA

using the OncoMate® MSI Dx Analysis System

Illustration of an electropharogram for CE calibration

Calibrate the Dye Spectrum

using the OncoMate® 5C Matrix Standards

Illustration of a capillary electrophoresis instrument

Separate and Detect Fragments

using the Applied Biosystems® 3500 Dx Genetic Analyzer

Illustration of an electropherogram the OncoMate MSI Dx Analysis System

Data Analysis and Reporting

using the OncoMate® MSI Dx Interpretive Software

Turnaround Time:
In as little as 10 hours or overnight

Reference

1. OncoMate® MSI Dx Analysis System Technical Manual #TM543 (2021) Promega Corporation.

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.

Protocolos

Complete Protocol

OncoMate™ MSI Dx Interpretive Software Reference ManualPDF (6135 KB) – English

SDS

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Certificado de Análisis

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Use Restrictions

For In Vitro Diagnostic Use. This product is only available in certain countries.

OncoMate® MSI Dx Interpretive Software
for Automated MSI Data Interpretation

IVD Software for OncoMate® MSI Data Interpretation and Reporting

Accurate and Sensitive Automated MSI Data Interpretation

Accurately Determine the MSI Status of Colorectal Cancers Using the Gold Standard Method