Chinese Regulators OK Promega’s ProDx MSI Detection Kit 

Promega’s ProDx MSI Detection Kit has been awarded an innovative medical device registration certificate from China’s National Medical Products Administration (NMPA). This kit uses the fluorescent PCR-capillary electrophoresis method to qualitatively detect eight microsatellite loci in tumor tissue.

The ProDx MSI Detection Kit will be used to characterize colorectal cancers for microsatellite instability as an aid to identify patients that would benefit from additional genetic testing to diagnose Lynch syndrome. This approval represents a key step forward in providing advanced diagnostic tools to clinical laboratories in China.

“This certificate is the culmination of a years-long effort to bring this innovative technology into clinical laboratories in China,” Promega Shanghai General Manager Tom Duan said. “It gives clinicians an invaluable tool for generating critical diagnostic data thereby contributing to colorectal cancer prevention, improving early diagnosis and enhancing patient survival rates.”

Microsatellite instability is a form of genomic instability caused when uncorrected errors during DNA replication result in too many or too few bases at specific repeat sequences, called microsatellites. MSI status is used to screen for Lynch syndrome, a hereditary predisposition to several cancers that is the most common inherited cause of colorectal cancer. High-frequency MSI (MSI-H) is an indication that patients should be referred for further genetic testing for Lynch syndrome.

Promega has more than 20 years of experience in MSI research. The company’s PCR-based method for detecting MSI has been used in clinical research worldwide, and has appeared in more than 225 independent peer-reviewed publications across 30 different cancer types.

ProDx MSI Detection Kit is exclusively available for sale in China. Promega MSI technology is also used in an IVD test in the United States and a CE-marked IVD medical device in the United Kingdom and select European countries.

Promega Corporation provides solutions and technical support to the life sciences industry. The company’s portfolio of more than 4,000 products supports numerous life science work across areas such as cell biology; DNA, RNA and protein analysis; drug development; human identification; and molecular diagnostics. These tools and technologies have grown in their application over the last 45 years and are used today by scientists and technicians in labs. Promega is headquartered in Madison, Wis., and maintains branches in 16 countries and works with more than 50 global distributors.