July 2021 –
Promega, Corp. received FDA approval for the clinical use of their OncoMate® MSI DX Analysis System to determine microsatellite instability (MSI) in colorectal cancer tumors.
This is the first FDA-approved PCR-based diagnostic MSI characterization kit for clinical use in the U.S. Their new multiplex MSI assay utilizes novel long mononucleotide repeat markers for improved MSI sensitivity across all cancer types and is approved for research use in the U.S. The Colon CFR contributed colorectal cancer and endometrial cancer tissue samples as the most common Lynch syndrome tumors but also provided less common cancers including ovary, stomach, small intestine, kidney, breast and prostate tissue samples to expand the diagnostic range of OncoMate® MSI DX.
The poster below describes the development of this highly sensitive pan-cancer test.