- Promega MSI technology is now available in a diagnostic test in China
- National Medical Products Administration (NMPA) awarded a medical device registration certificate to Promega ProDx MSI Detection Kit
- ProDx MSI Detection Kit will be used to screen colorectal cancer patients to identify those who may benefit from additional genetic testing to diagnose Lynch syndrome
MADISON, Wis.--(BUSINESS WIRE)--Promega announced that the ProDx MSI Detection Kit has been awarded an innovative medical device registration certificate from the National Medical Products Administration (NMPA) in China. This kit utilizes the fluorescent PCR-capillary electrophoresis method to qualitatively detect eight microsatellite loci in tumor tissue. 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,” says Tom Duan, General Manager of Promega Shanghai. “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 Analysis
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 around the world, as well as 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.
About Promega Corporation
Promega Corporation is a leader in providing innovative solutions and technical support to the life sciences industry. The company’s portfolio of over 4,000 products supports a range of 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 for academic and government research, forensics, pharmaceuticals, clinical diagnostics and veterinary, agricultural and environmental testing. Promega is headquartered in Madison, WI, USA with branches in 16 countries and over 50 global distributors. Learn more at promega.com
Contacts
Penny Patterson
VP, Corporate Affairs
Promega Corporation
Phone: (608) 274-4330
E-mail: penny.patterson@promega.com
