MADISON, Wis.– Promega Corporation today launched its OncoMate™ MSI Dx Analysis System (OncoMate™ MSI) in vitro diagnostic (IVD) in the US, giving oncologists and pathologists a new option to screen for Lynch syndrome in patients with colorectal cancer. OncoMate™ MSI was cleared by the US Food and Drug Administration (FDA) last month as an IVD medical device to determine microsatellite instability (MSI) status in colorectal cancer tumors.
OncoMate™ MSI is based on Promega technology that has been a gold standard around the world for the last 15 years for studying MSI status in solid tumors. It is the industry’s first and only PCR-based diagnostic kit for MSI characterization that is FDA-cleared for use in labs in the US.
DNA is constantly copying itself. MSI is a form of genomic instability caused when too many or too few repeating bases, called microsatellites, occur during DNA replication and the body’s mismatch repair system fails to correct these errors. MSI status is used to screen for Lynch syndrome.
Lynch syndrome is an inherited condition that increases the risk of developing colorectal and other cancers. It is the most common inherited cause of colorectal cancer. An estimated 1 in 279 people have Lynch syndrome but 95% do not know they have it. High-frequency MSI (MSI-H) is an indication that patients should be referred for further genetic testing for Lynch syndrome. This information is crucial not only for the patient, but for family members as well.
