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.
Enzo Biochem said this week that its Enzo Clinical Labs division is now providing Roche Diagnostics' H1N1 PCR test for physicians throughout the Metropolitan New York, including New Jersey and parts of Pennsylvania.
Roche gained an Emergency Use Authorization from the US Food and Drug Administration for its RealTime ready Influenza A/H1N1 Detection Set last November.
The kit detects RNA from the 2009 H1N1 influenza A virus and is used in conjunction with Roche's RealTime ready RNA Virus Master kit.