Seegene Receives Approval From Health Canada For Its Respiratory Virus Multi-Pathogen Detection Tests

Main Category: Respiratory / Asthma
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 12 Dec 2008 - 1:00 PDT

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Seegene, Inc., a leader in multi-pathogen diagnostic testing, today 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 novel and proprietary Seeplex(R) molecular diagnostic platform that delivers maximum specificity, reproducibility and sensitivity, 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.

"The advantages of Seegene's novel rapid diagnostic tests will be manifold. With these tests, the therapies targeting a specific pathogen causing the infection for a specific patient can be prescribed much earlier. Another benefit of the test is its ability to enable the continual monitoring of the infection status, which offers a strong potential for reducing hospital stays and freeing up scarce resources for other healthcare needs," said Jong-Yoon Chun, Founder and Chief Executive Officer, Seegene.

The ease-of-use for caregivers administering the Seeplex RV5 and RV12 tests and the rapidity of receiving conclusive results belies the power of these multi-pathogen assays to simultaneously test for the most prevalent respiratory viruses.

Jong-Yoon Chun added, "The issuing of a Medical Device License from Health Canada is another important milestone for Seegene. In this era of viral epidemics clinicians require the ability to routinely test for a wide spectrum of respiratory pathogens in a single test. The Seeplex RV tests are 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."

About Seegene

Seegene, Inc. is a biotechnology company specialized in molecular diagnostics and research applications. It holds a novel detection platform named "Seeplex(R)," which sets a standard in high-throughput and simultaneous multi-pathogen detection called "multiplexing." Seeplex(R) technology accurately detects multi-pathogens with high-throughput speed, ultimately providing the most economical basis for saving time, labor and cost. Seegene develops, manufactures and markets innovative molecular diagnostic products and services to a worldwide community. The company has more than 47 distributors in 28 countries, including 2 subsidiary offices in the US and Japan. Its mission is to maintain leadership in molecular diagnostics for infectious diseases, genetics, pharmacogenetics, and oncology, and chromosomal analyses using innovative proprietary technologies.

Seegene, Inc.