SOURCE: Seegene

Seegene

January 11, 2010 08:52 ET

Seegene Seeplex® Diarrhea-V ACE Detection Test Receives a Medical Device License From Health Canada

Rapid Testing for Multiple Pathogens Gives Canadian Laboratories a Fast and Effective Tool to Respond to Symptomatic Patients for Either Isolated Cases or Epidemic Outbreaks

ROCKVILLE, MD and SEOUL, SOUTH KOREA--(Marketwire - January 11, 2010) - Seegene, Inc., a leader in multiplex PCR pathogen diagnostic testing, today announced that it has received a Medical Device License from Health Canada for its Seeplex® Diarrhea-V ACE Detection test. Built on the novel and proprietary Seeplex® molecular diagnostic platform that delivers maximum specificity, reproducibility and sensitivity, the Canadian healthcare system can now use the Seegene viral diarrhea detection kit to further improve patient care and reduce healthcare costs.

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.

Between 70-80% of all cases of diarrhea are caused by viruses. Rotavirus, which usually infects children under five years old, causes about 2.7 million cases of severe gastroenteritis, almost 60,000 hospitalizations, and around 37 deaths each year in the United States. In the United Kingdom during the 2007 winter season, an estimated three million people contracted a virus attributed to food poisoning causing 100 hospital wards to be temporary closed due to contamination.

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).

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.

"In this era of viral epidemics clinicians require the ability to routinely test for a wide spectrum of pathogens in a single test," said Jong-Yoon Chun, Founder and Chief Executive Officer, Seegene. "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."

About Seegene

Seegene, Inc. is a biotechnology company specialized in molecular diagnostics and research applications. It holds a novel detection platform named "Seeplex®," which sets a standard in high-throughput and simultaneous multi-pathogen detection called "multiplexing." Seeplex® 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 for infectious diseases, genetics, pharmacogenetics, and oncology, and chromosomal analyses suing innovative proprietary technologies. For more information please visit www.seegene.com or call +301-762-9066.

Contact Information

  • Contacts:
    Hyunsoo Kim, Ph.D.
    Seegene, Inc.
    301-762-9066
    Email Contact
    or
    Constantine Theodoropulos
    BasePair Communications
    617-401-3116