NEW YORK – Promega said Tuesday that its ProDx MSI Detection Kit has received an innovative medical device registration certificate from China's National Medical Products Administration (NMPA).
According to a company spokesperson, the certificate "represents full approval for the ProDx MSI Detection Kit to be used for diagnostic testing in China." The kit was reviewed through the NMPA's innovative device pathway, which expedites approval for certain technologies deemed to have significant clinical value.
Following the approval, the kit is now available for clinical testing in China to screen for high-frequency microsatellite instability (MSI-H) in colorectal cancer patients in order to identify those who may benefit from additional genetic testing for Lynch syndrome.
The kit uses fluorescent PCR coupled with capillary electrophoresis to qualitatively detect eight microsatellite loci in tumor tissue.
"This certificate is the culmination of a yearslong effort to bring this innovative technology into clinical laboratories in China," Tom Duan, general manager of Promega Shanghai, said in a statement.
Promega's OncoMate MSI Dx Analysis System, which uses the same MSI technology, has already been cleared by the US Food and Drug Administration and CE-marked as an IVD medical device.