Promega Microsatellite Instability Technology Receives Innovation Designation from Chinese National Medical Products Administration
Madison, WI USA. (January 2, 2019)
Promega Corporation’s latest microsatellite instability (MSI) technology has been granted innovation designation by the Chinese National Medical Products Administration (NMPA). Promega MSI technology has been validated in labs around the world. With innovation status, the path to become classified as an invitro diagnostic (IVD) will gain elevated efficiency by having a program coordinator assigned from NMPA and priority status for multiple processes.
“We are excited and honored with this decision from NMPA,” says Frank Fan, Senior Director of Research & China Operations at Promega. “Our Promega China team appreciated the emerging and important role our MSI technology can play in health care because of its sensitivity and prominent use around the world. Innovation Designation accelerates our hope to get the best tools in the hands of clinicians and bring benefits to patients.”
This version of the Promega MSI platform, trademarked ProDx® in China, is the latest version (MSI 2.0) of the Promega MSI technology. This technology is a PCR-based method for detecting MSI, a form of genomic instability caused by the insertion or deletion of repeating bases called microsatellites during DNA replication and the failure of the mismatch repair system to correct these errors. MSI status is a measure of mismatch-repair deficiency commonly found in solid tumors, providing oncologists, pathologists and patients more information to determine the best treatment path. This new MSI technology is currently being accessed globally in investigator-initiated trials to determine its application in solid tumors beyond colon cancer.
Promega continues to advance the promise of MSI technology globally. In the US, Promega intends to seek Food and Drug Administration (FDA) approval for IVD status of the MSI 1.2 platform. A 2018 College of American Pathologists survey indicated that 70% of respondents performing nucleic acid based MSI testing were doing so using the Promega MSI 1.2 panel of loci.
About Promega Corporation
Promega Corporation is a leader in providing innovative solutions and technical support to the life sciences industry. The company’s 4,000 products enable scientists worldwide to advance their knowledge in genomics, proteomics, cellular analysis, drug discovery and human identification. Founded in 1978, the company is headquartered in Madison, WI, USA with branches in 16 countries and over 50 global distributors. For more information about Promega, visit www.promega.com.