OncoMate® MSI Dx Analysis Software
IVD Software for OncoMate® MSI Data Analysis 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
- Clinically validated to support the companion diagnostic intended uses of the OncoMate® MSI Dx Analysis System.
Catalog Number:
Size
Catalog Number: MD4160
Companion Diagnostic 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.
Confident MSI Determination in Solid Tumors
The OncoMate® MSI Dx Analysis Software is the interpretation component of the FDA-approved OncoMate® MSI Dx Analysis System. Performance has been characterized to identify MSI-H solid tumors as well as MSS (not MSI-H) endometrial carcinomas. Both populations have historically been more challenging for MSI detection due to subtle instability patterns. See Cat. # MD2140 OncoMate® MSI Dx Analysis System Technical Manual #TM543 for full study design, and complete results.
Endometrial Carcinomas: Identification of MSS
(not MSI-H) companion diagnostic clinical efficacy
In the subset of clinical study participants with MSS (not MSI-H) tumor status by the OncoMate® MSI Dx Analysis System, combination therapy efficacy (objective response rate, ORR) was comparable to the efficacy in all clinical trial assay pMMR (CTA-pMMR) participants randomized in the study.
Accuracy of MSS
Agreement with a reference immunohistochemistry (IHC) method in endometrial carcinoma.
99.0% Positive percent agreement, MSS to pMMR
91.7% Negative percent agreement, MSI-H to dMMR
Solid Tumors: Identification of MSI-H companion diagnostic clinical efficacy
In a subset of clinical study participants with MSI-H tumor status determined by the OncoMate® MSI Dx Analysis System, therapy efficacy (objective response rate, ORR) of the CDx-defined population was comparable to that observed in the original treatment authorization.
Accuracy of MSI-H
Agreement across solid tumors with a reference immunohistochemistry (IHC) method for mismatch repair protein expression.
88.7% Positive percent agreement, MSI-H to dMMR
97.2% Negative percent agreement, MSS to pMMR
The FDA-approved OncoMate® MSI Dx Analysis Software (Cat.# MD4160) is available in the United States, American Samoa, Guam, Puerto Rico, and the US Virgin Islands. For information about availability in other regions, please contact us.
Quick, Automated Analysis with Full Data Visibility
Capillary electrophoresis data is imported directly into the software, checked, scored, and reported.
- See Your Data: Instrument electropherogram data is displayed for every sample, with fragment sizing and marker-level summary behind each call. You are never handed a result you cannot inspect.
- Quality Control Built into Every Result: Data quality is evaluated before a result is determined, meaning every patient result rests on data that meets defined criteria. Embedded quality checks confirm an MSS (not MSI-H) result rather than an absence of detected signal.
- Validated automated interpretation: Validated scoring logic produces an objective MSI-H or MSS result quickly and consistently, with standardized, structured reports and audit trail information to support CAP, CLIA, and other laboratory quality management requirements.
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 who may benefit from immunotherapy or 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.
Isolate DNA
From FFPE tumor samples and blood or FFPE normal samples using nucleic acid extraction reagents and instruments
Quantitate DNA
using fluorescent DNA quantitation reagents (e.g., QuantiFluor® Dx dsDNA System) and instruments
Amplify DNA
using the OncoMate® MSI Dx Analysis System
Calibrate the Dye Spectrum
using the OncoMate® 5C Matrix Standards
Separate and Detect Fragments
using the Applied Biosystems® 3500 Dx Genetic Analyzer
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 (2026) 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) solid tumor 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 who may benefit from treatment with the targeted therapies listed in (Table 1 or below) in accordance with the approved therapeutic product labeling.
OncoMate® MSI Dx Analysis System Companion Diagnostic Indications.
| Indication | Biomarker | Therapy |
|---|---|---|
| Endometrial Carcinoma | MSS; defined as not MSI-high [not MSI-H] | KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, in combination with LENVIMA® (lenvatinib), the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai |
| Solid Tumors | MSI-H | KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy |
Medical Information
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Protocols
Specifications
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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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OncoMate® MSI Dx Analysis System
IVD Medical Device for MSI testing. PCR-based fragment-sizing test used to determine microsatellite instability (MSI) status.
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OncoMate® 5C Matrix Standard
Used to calibrate capillary electrophoresis instruments prior to running the OncoMate® MSI Dx Analysis System.
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QuantiFluor® Dx dsDNA System
Fluorescent DNA-binding dye that enables sensitive quantification of small amounts of double-stranded DNA (dsDNA) in a purified sample. For In Vitro Diagnostic Use.
E5900
