Promega has secured approval from the US Food and Drug Administration (FDA) for its OncoMate MSI Dx Analysis System (OncoMate MSI).
The approval allows to use OncoMate MSI as an IVD medical device to determine microsatellite instability (MSI) status in colorectal cancer tumours.
OncoMate MSI is claimed to be the industry’s first and only PCR-based diagnostic kit for MSI characterisation, which is FDA-cleared for use in labs across the US.
Lynch syndrome is an inherited condition, which escalates the risk of developing colorectal and other cancers.
Johns Hopkins University School of Medicine pathology and oncology professor Dr James Eshleman said: “Tools that enable the accurate determination of the MSI status of colorectal cancer tumors are vital for patients and their families.
“An FDA-cleared MSI diagnostic kit gives patients, oncologists, and pathologists in the U.S. access to technology that, for the last 15 years, has been a gold standard around the world for study MSI Status in solid tumours.”
Promega stated that OncoMate MSI is based on the company’s “for research use only” technology and the first commercially manufactured kit to detect MSI status.
OncoMate MSI is also a CE-marked IVD medical device in the UK, as well as in the select European countries.
The company is also planning to seek regulatory approval for a Promega MSI IVD in China. The Promega MSI technology already secured innovation status and priority review from the China’s National Medical Products Administration (NMPA).
In June this year, Promega secured CE mark approval for its novel antibody bioluminescent immunoassay called Lumit Dx SARS-CoV-2 Immunoassay.
