Seegene said this week that Health Canada has granted it a Medical Device License for its Seeplex Diarrhea-V ACE Detection test.
The company said that the multiplex assay uses proprietary PCR technology to simultaneously amplify target pathogens. The test detects a range of viral pathogens that cause diarrhea, including enteric adenovirus, Group A rotavirus, Norovirus GI/GII, and Astrovirus
The license from Health Canada is the first approval for the test in North America. It is already CE-Marked for use in Europe.