Dx Focus: Clinical and Regulatory PCR and Nucleic Acid Testing News

Jan 14, 2010

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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.

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