Seegene Receives Approval from Health Canada for Its Respiratory Virus Multi-Pathogen Detection Tests

08-Dec-2008 - Canada

Seegene, Inc. announced that it has received a Medical Device License from Health Canada for its Seeplex(R) RV5 ACE (Auto Capillary Electrophoresis) Screening and RV12 ACE Detection tests. Built on the proprietary Seeplex(R) molecular diagnostic platform, the Canadian healthcare system can now use the RV5 and RV12 diagnostic tests to further improve patient care, reduce healthcare costs and prevent inappropriate antibiotic use.

Quickly detecting the specific cause of respiratory infections, especially for children, the elderly, and patients whose conditions are compromised by asthma or immune system complications is critical due to the high incidence of these pathogens developing into serious diseases. Unfortunately, respiratory disease caused by viral infection cannot be simply determined from clinical symptoms as most viruses induce both upper and lower respiratory infections.

Using the Seeplex RV5 test, doctors can now simultaneously detect the most prevalent flu viruses such as influenza A, influenza B, and respiratory syncytial virus A/B, and screen for 11 viruses, while the RV12 test identifies 12 viruses individually.

Already permitted for use in more than 30 countries recognizing the CE Mark, the license from Health Canada will bring the RV5 ACE Screening and RV12 ACE Detection tests to North America for the first time. In the United States, more than 50 million unnecessary antibiotic prescriptions are written each year for patients outside of hospitals, according to the Centers for Disease Control and Prevention.

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