FDA Authorizes Promega OncoMate System

The United States oncologists, and pathologists are now allowed access to a novel in vitro diagnosed (IVD) test. This is particularly for analysing patients with colorectal cancer identifying the signs of Lynch syndrome. The OncoMate MSI or OncoMate MSI Dx Analysis System introduced by Promega has recent secured the United States Food and Drug Administration (FDA). FDA has cleared the use of the new technology as an IVD medical device to analyse microsatellite instability (MSI) in patients with colorectal cancer tumors.

The peculiarity of the new device is attributed to the novel technology. It is a breakthrough device posing as the industry’s very first PCR-based diagnostic technology kit targeting MSI characterization. The new MSI Dx Analysis System is allowed to be applied in labs across the United States.

Approval of the MSI diagnostic kit is a promising opportunity to enhance the accessibility for patients, oncologists, and pathologists across the United States. It is one such technology that has been severely lacking in the diagnostic industry for the last 15 years. According to surveys, 1 in every 279 people have Lynch syndrome. However, only 95% are diagnosed or are aware of the acquired condition. The analysis of high-frequency MSI suggests that the patients should undergo genetic testing for lynch syndrome. Thus, accurate analytical tools to determine the MSI status of colorectal tumors are essential.

MSI refers to a genomic instability in individuals. This is a ripple effect when excessive or deficit number of microsatellites occur during DNA replication. Followed by which the mismatch repair system of human body fails to acknowledge, and fix the errors.