OncoMate® MSI Dx Analysis Software

MSI Data Interpretation

The OncoMate® MSI Dx Analysis Software delivers consistent, automated MSI status determination from fragment analysis data generated by the OncoMate® MSI Dx Analysis System. Raw capillary electrophoresis data is imported directly into the software, evaluated against built-in data quality checks, and scored using validated logic to produce an objective MSI-H or MSS result. Standardized interpretation reduces the operator-to-operator variability associated with manual peak review and streamlines analysis for higher-volume clinical workflows. Outputs include standardized, structured reports with audit trail information to support CAP, CLIA, and other laboratory quality management requirements.

Performance has been characterized in endometrial carcinoma, a tumor type historically more challenging for MSI detection due to more subtle instability patterns. The OncoMate MSI Dx workflow demonstrated 99.0% positive percent agreement (MSS to pMMR) and 91.7% negative percent agreement (MSI-H to dMMR) against a reference IHC method.

The FDA-approved Oncomate(R) MSI Dx Analysis Software (Cat. # MD4160) is available in the United States only. For information about availability in other regions, please contact us.

Accurately Determine MSI Status 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). With FDA approval as a companion diagnostic, the OncoMate® MSI Dx Analysis System now provides clinicians with a validated tool to identify patients with MSS (not MSI-H) endometrial carcinoma who may benefit from combination therapy options.

Sample to Answer Overnight

The OncoMate® MSI Dx Analysis System for use as a companion diagnostic 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 tumor samples and blood or FFPE normal samples using nucleic acid extraction reagents and instruments

Quantitate DNA

using fluorescent DNA quanitation 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 Analysis 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 five microsatellite loci (BAT-25, BAT-26, NR-21, NR-24 and MONO-27) for the identification of microsatellite instability (MSI) using DNA obtained from formalin-fixed, paraffin-embedded (FFPE) endometrial carcinoma tissue specimens, and DNA isolated from matched normal FFPE specimen or whole blood. The OncoMate® MSI Dx Analysis System is for use with the Applied Biosystems® 3500 Dx Genetic Analyzer and OncoMate® MSI Dx Analysis Software.

The OncoMate® MSI Dx Analysis System is indicated for use as a companion diagnostic test to identify patients with microsatellite stable (MSS; defined as not MSI-high [not MSI-H]) endometrial carcinoma who may benefit from treatment with KEYTRUDA® (pembrolizumab) in combination with LENVIMA® (lenvatinib) in accordance with the approved therapeutic product labeling.

Protocols

Complete Protocol

OncoMate® MSI Dx Analysis Software Technical ManualPDF (5883 KB) – English

SDS

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Certificate of Analysis

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Use Restrictions

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

OncoMate® MSI Dx Analysis Software

Part Numbers: MD4160

IVD Software for OncoMate® MSI Data Analysis and Reporting

MSI Data Interpretation

Accurately Determine MSI Status Using the Gold Standard Method