FDA clears Promega OncoMate™ MSI Dx Analysis System (Promega Press Release)
"Oncologists and pathologists in the United States can now access a new in vitro diagnostic (IVD) test that screens for Lynch syndrome in patients with colorectal cancer. The OncoMate™ MSI Dx Analysis System (OncoMate™ MSI), developed by Promega, has been cleared by the US Food and Drug Administration (FDA) as an IVD medical device to determine microsatellite instability (MSI) status in colorectal cancer tumors. This is the industry's first and only PCR-based diagnostic kit for MSI characterization that is FDA-cleared for use in labs across the United States."