Madison-based Promega has received U.S. Food and Drug Administration (FDA) approval for a new in vitro diagnostic test that screens for Lynch syndrome in patients with colorectal cancer, according to a release from the company. The OncoMate MSI Dx Analysis System developed by Promega has been cleared by the U.S. Food and Drug Administration as a medical device to determine microsatellite instability status in colorectal cancer tumors. This is the industry’s first diagnostic kit of its kind that is FDA-cleared for use in labs across the United States. Lynch syndrome is an inherited condition that increases the risk of developing colorectal and other cancers.
Related story: Promega seeks FDA approval for Lynch syndrome test
