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FDA approved Promega MSI Dx kit for the detection of MSI in colorectal cancer
FDA approved Promega MSI Dx kit for colorectal cancer (CRC). Promega applied for FDA approval for its MSI kit as early as 2017.
The global incidence of colorectal carcinoma (CRC) is increasing year by year. Among them, patients with Lynch syndrome have a higher risk of colorectal cancer. In addition to routine colonoscopy or FIT-DNA testing, Microsatellite Instability (MSI) testing can also be used to screen patients with colorectal cancer for Lynch syndrome. (Editor’s note: Lynch syndrome is an autosomal dominant genetic disease caused by genetic mutation DNA mismatch, that is, mismatch repair. It has a higher risk of colorectal cancer, accounting for 2% to 5 of colorectal cancer. %.)
On July 28, Promega of the United States announced that its OncoMate MSI Dx (MSI stands for Microsatellite Instability) kit has been approved by the FDA.
Promega’s OncoMate MSI Dx is a multiplex fluorescent PCR kit targeting single nucleotide repeats for the detection of MSI in colorectal cancer. Usually after PCR amplification of the DNA samples of the patient’s normal tissue and tumor tissue, the instability is determined by the fragment size analysis on the capillary electrophoresis instrument. The sample required is small, and a part of formalin-fixed paraffin-embedded sections can be used for testing, and the results can be obtained within about 10 hours.
To a certain extent, guidelines from the National Comprehensive Cancer Network (NCCN) and the American Society of Clinical Oncology (American Society of Clinical Oncology) also recommend MSI testing for colorectal tumors. James Eshleman, Professor of Pathology and Oncology at Johns Hopkins University School of Medicine, said: “Tools that can accurately determine the MSI status of colorectal cancer tumors are critical for patients and their families. The FDA-approved MSI diagnostic kit makes the United States Patients, oncologists, and pathologists have access to technology. For the past 15 years, this technology has been the gold standard for studying MSI status in solid tumors worldwide.”
Promega applied for FDA approval for its MSI kit as early as 2017, and subsequently announced that it would cooperate with Merck to develop companion diagnostics for pembrolizumab (Keytruda or “K drug”). The company also recently agreed to develop its OncoMate MSI as a companion diagnostic test for Incyte’s anti-PD-1 drug candidate retivalimumab in endometrial cancer. OncoMate MSI also has the CE-IVD mark in the UK and some European countries. At present, the Promega MSI kit has also entered the National Medical Products Administration (NMPA) special approval channel for medical devices in China.
(source:internet, reference only)