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TEST:
OncoMate™ MSI

Company:
Promega
Type:
CE Marked
Related tests:
Evidence

News

4ms
Evaluation of an Investigational Software for Analysis of Microsatellite Instability in Multiple Cutaneous Cancers (USCAP 2024)
PCR analysis using the Promega OncoMate® MSI Dx Analysis System with an investigational data interpretation software correlates with evaluation of MMR expression by IHC in 94% of cases, among the tumor types evaluated. MSI-high results reliably (100% in this sample) predict loss of MMR protein IHC staining, but occasional cases yield MSS results while having MMR loss by IHC.
Microsatellite instability • MSi-H Biomarker • IO biomarker
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MSI (Microsatellite instability)
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MSI-H/dMMR
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OncoMate™ MSI
4ms
Differences in performance of DNA Mismatch Repair Immunohistochemistry and Microsatellite Instability PCR Test in Cancers of Colorectum, Endometrium and Other Organs (USCAP 2024)
Concordance between MMR IHC and the Oncomate MSI PCR assay was 100% for CRC but for other cancers may be lower. The MSI PCR test has low sensitivity in cases with isolated MSH6 loss, supporting the recommendation that MMR IHC may be favored over PCR in cancers such as those of endometrium.
Microsatellite instability • MSi-H Biomarker • Mismatch repair
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MSI (Microsatellite instability) • MLH1 (MutL homolog 1) • MSH6 (MutS homolog 6) • MSH2 (MutS Homolog 2) • PMS2 (PMS1 protein homolog 2) • PMS1 (PMS1 protein homolog 1)
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MSI-H/dMMR
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OncoMate™ MSI
7ms
An innovative and accurate next-generation sequencing-based microsatellite instability detection method for colorectal and endometrial tumors. (PubMed, Lab Invest)
This new NGS-based MSI detection method outperforms previously published methods (i.e. Idylla, OncoMate MSI Dx, and Foundation One® CDx). Although highly efficient, Octaplex CaBio-MSID requires validation in a larger independent series of different tumor types.
Journal • Microsatellite instability • IO biomarker • Next-generation sequencing
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MSI (Microsatellite instability)
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MSI-H/dMMR
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FoundationOne® CDx • Idylla™ MSI Test • OncoMate™ MSI
8ms
Validation of the OncoMate™ MSI Dx Analysis System (Promega) on the Applied Biosystems® 3500xL Genetic Analyzer System (AMP 2023)
Our testing with the OncoMate MSI Dx Analysis System (Promega) matched for all the expected results. This MSI analysis protocol has been deemed acceptable based on our validation studies and will be used in clinical testing.
MSi-H Biomarker
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MSI (Microsatellite instability) • KIT (KIT proto-oncogene, receptor tyrosine kinase) • MSH2 (MutS Homolog 2)
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MSI-H/dMMR
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OncoMate™ MSI
8ms
The Idyllaâ„¢ MSI Test (IVD): An Automated PCR-Based System for the Determination of MSI Status as an Aid for Identification of Probable Lynch Syndrome in Colorectal Cancer Patients (AMP 2023)
The Idylla MSI Test is a clinically valid method for dMMR screening in CRC patients, and results of this testing can be used to guide further evaluation of individuals for Lynch syndrome. All percentage agreement point estimates used to determine the success of the study exceeded the 90% benchmark established a priori.
Clinical
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MSI (Microsatellite instability)
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MSI-H/dMMR
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Ventana MMR RxDx Panel • Idylla™ MSI Test • OncoMate™ MSI • TumorNext-Lynch
8ms
Evaluation of Three Methods for Lynch Syndrome Screening in Patients with Colorectal Cancer (AMP 2023)
The Promega OncoMate MSI Dx analysis system shows excellent concordance with the previous Promega MSI analysis system v1.2 and MMR IHC in CRC tumor samples, and has clinical utility in screening for LS in CRC patients.
Clinical • MSi-H Biomarker
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MSI (Microsatellite instability) • MLH1 (MutL homolog 1) • MSH6 (MutS homolog 6) • MSH2 (MutS Homolog 2) • PMS2 (PMS1 protein homolog 2)
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MSI-H/dMMR • MSH2 mutation • MLH1 mutation • PMS2 mutation
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OncoMate™ MSI
1year
Discrepancy in microsatellite instability status as determined by MSI-PCR versus MMRD-immunohistochemistry (EACR 2023)
IHC testing in our study incorrectly defined MSI status in 5%, which can be considered as a high error rate. We suggest parallel testing as an alternative approach for MSI/MMRD detection in malignant tumors to achieve correct identification of patients with Lynch syndrome and to detect the ones who qualify for immunotherapy.
Microsatellite instability • MSi-H Biomarker • IO biomarker
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MSI (Microsatellite instability) • MLH1 (MutL homolog 1) • MSH6 (MutS homolog 6) • MSH2 (MutS Homolog 2) • PMS2 (PMS1 protein homolog 2)
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MSI-H/dMMR
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OncoMate™ MSI
almost2years
Critical aspects of MSI testing in endometrial cancer: a comparison study. (PubMed, Hum Pathol)
"Otherwise, HRM approaches and microcapillary electrophoresis platform failed to detect MSI-ECs showing minimal microsatellite shifts. In conclusion, whereas in colorectal site several technologies are eligible for MSI test, in ECs MSI test should be based on fluorescent capillary electrophoresis as it identifies a higher proportion of cases that could be misdiagnosed with other strategies."
Journal
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MSI (Microsatellite instability)
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MSI-H/dMMR
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EasyPGX® ready MSI • Idylla™ MSI Test • OncoMate™ MSI
over2years
[VIRTUAL] Performance of the OncoMate™ MSI Dx Analysis System (AMP 2021)
Learn about the clinical performance of the new OncoMate™ MSI Dx Analysis System, the industry’s first FDA-cleared, PCR-based diagnostic kit for MSI status. The system uses an improved format of the most globally relied upon gold standard loci, which are recommended by NCCN Clinical Practice Guidelines In Oncology (NCCN Guidelines®) and other leading cancer organization guidelines.
MSI (Microsatellite instability)
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OncoMate™ MSI
over3years
[VIRTUAL] Sponsored session: From FFPE to liquid biopsy: Applications for MicroSatellite Instability (MSI) testing now and in the future. (NCRI 2020)
– Jeff Bacher, Sr Research Scientist 2, Promega Clinical Utility of MSI testing for Lynch syndrome and anti-PD1 immunotherapy: The Pathologists Perspective. – Dr Anca Oniscu, Consultant Pathologist and Clinical Lead for Molecular Pathology, Laboratory Medicine, Edinburgh Royal Infirmary.
Microsatellite instability • PD(L)-1 Biomarker • MSi-H Biomarker • IO biomarker • Liquid biopsy
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MSI (Microsatellite instability)
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MSI-H/dMMR
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OncoMate™ MSI