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Clinical MSI Testing IVD

Promega offers physicians a precision in vitro diagnostic assay for evaluating MSI status. The OncoMate™ MSI Dx Analysis System is an IVD medical device, leveraging the same validated gold standard Promega MSI loci relied on by global clinical researchers for almost two decades. The improved system offers reliable MSI determination with strong agreement to IHC.

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What is the Clinical Importance of MSI Status in Cancer?

MSI status is a biomarker that is used to identify candidates for further diagnostic testing for Lynch Syndrome. Lynch syndrome is a genetic predisposition to cancer caused by autosomal dominant mutations to the major mismatch repair genes MLH1, MSH2, MSH6 or PMS2 as well as the EPCAM gene that inactivates MSH2. Most often associated with colorectal cancer, Lynch syndrome also increases the lifetime risk of several other cancers including endometrial, ovarian and stomach cancer.

Universal screening of all colorectal cancer tumors for MSI status is recommended in guidelines by numerous physician-led organizations including the National Comprehensive Cancer Network (NCCN®)1 as well as the American Society for Clinical Pathology (ASCP), College of American Pathologists (CAP), Association for Molecular Pathology (AMP), American Society of Clinical Oncology (ASCO)2.

Learn more about MSI testing in the Microsatellite Instability Resource Center.

  1. To view the most recent and complete version of NCCN Guidelines®, go online to nccn.org.
  2. Sepulveda, A.R., et al. (2017) J. Mol. Diag. 19, 187–225.

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