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OncoMate™ MSI Dx Interpretive Software
for Automated MSI Data Interpretation

md4140-oncomate-msi-dx-interpretive-software

IVD Software for OncoMate™ MSI Data Interpretation and Reporting

  • Visualize the instrument electropherogram data generated using the OncoMate™ MSI Dx Analysis System
  • Fragment sizing functionality and summary for detailed data understanding
  • Incorporated data quality control ensures reliable data is used in interpretation
  • Provided MSI determination with 97.8% PPA and 97.2% NPA to MMR by IHC

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OncoMate™ MSI Dx Interpretive Software
for Automated MSI Data Interpretation
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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

Illustration of a Quantus Fluorometer
Quantitate DNA

using fluorescent DNA quantitation reagents 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

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Turnaround Time:
In as little as 10 hours or overnight

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Reference

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

Have a Question or Need Product Support?

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.

Specifications

Certificate of Analysis

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Use Restrictions

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

Storage Conditions

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