Seegene has received a medical device license from Health Canada for its Seeplex Diarrhea-V ACE Detection test.
Built on the new Seeplex molecular diagnostic platform that delivers maximum specificity, reproducibility and sensitivity, the Canadian healthcare system can use the Seegene viral diarrhea detection kit to further improve patient care and reduce healthcare costs.
The Seeplex Diarrhea-V ACE Detection is a qualitative in vitro test that responds to an unmet clinical need for rapid detection and diagnosis of a range of viral pathogens including enteric adenovirus (AdV), Group A rotavirus (RotV), Norovirus GI (NoV-G1) / GII (NoV-G2), Astrovirus (AstV).
Already permitted for use in more than 30 countries recognizing the CE Mark, the license from Health Canada will bring the Diarrhea-V ACE Detection test to North America for the first time, said the company.
The traditional methods for diagnosis of diarrhea are microscopy, ELISA, and stool culture, which have notable performance limitations that include a lack of both sensitivity and specificity, ease of use, and rapid turn-around for results.
Applying a proprietary polymerase chain reaction (PCR) technology, the Seeplex Diarrhea-V ACE Detection is a multiplex assay that permits the simultaneous amplification of target pathogens and provides a clear break from established procedures with accurate, rapid and cost-effective diarrhea diagnostics.
Jong-Yoon Chun, founder and chief executive officer of Seegene, said: “In this era of viral epidemics clinicians require the ability to routinely test for a wide spectrum of pathogens in a single test. The Seeplex Diarrhea-V test is uniquely performed with one multiplex PCR in a single tube and capillary electrophoresis for automated detection of pathogens providing a new standard for test reproducibility, specificity and sensitivity.”