Seegene Receives CE Mark For First Comprehensive Real-time PCR Gastrointestinal Infection Panels

CONCORD, CA and SEOUL, KOREA--(Marketwired - May 26, 2015) - Seegene Inc. (KOSDAQ: 096530), a leading developer of multiplex PCR technologies, today announced that its new Allplex™ Gastrointestinal (GI) Full Panel Assay has received CE-IVD mark enabling marketing in Europe and certain other markets. The test is based on Seegene’s proprietary MuDT™ technology enabling the detection of multiple target genes in a single channel without melt curve analysis.

The Allplex™ GI assay is the world’s first and only high-multiplexed test based on a real-time PCR platform that covers 25 bacterial, viral, and parasitic causes of gastrointestinal infectious disease. By testing for a broad spectrum of pathogens, the Allplex™ test provides molecular laboratory professions with a test having significant price competitiveness over other multi-analyte GI panels currently on the market. Furthermore, depending on the pathogen being detected, other currently available test technologies and methods can take several days to deliver a single result compared to hours for the Allplex test.

According to the World Health Organization (WHO), gastrointestinal infection is one of the top 10 leading causes of death in the world between 2000 and 2012 and remains the second leading contributor to morbidity among children under five globally.

“We are pleased to launch the Allplex™ GI assay in countries recognizing the CE mark. This test is very unique and powerful tool providing comprehensive and actionable diagnosis in the gastrointestinal diagnostic space. As part of Seegene’s global expansion initiatives in the molecular diagnostics market, we will continue to pursue a series of future submissions of other Allplex™ infectious disease tests in Europe, Canada and the U.S. markets,” said Dr. Chun, Jong-Yoon, Founder and CEO of Seegene.

About Seegene
Seegene is the world’s leading developer of multiplex molecular technologies and multiplex clinical molecular diagnostics (M-MoDx). Seegene’s core enabling technologies -- ACP™, DPO™, READ™, TOCE™, mTOCE™ and MuDT™ -- are the foundation for M-MoDx tests that can simultaneously detect multiple targets with high sensitivity, specificity and reproducibility. Seegene’s products detect multi-pathogens with great reliability and throughput, ultimately providing the most economical basis for saving time, labor and cost. Seegene’s mission is to maintain leadership in molecular diagnostics for infectious diseases, genetics, pharmacogenomics, and oncology using innovative proprietary technologies.

For more information please visit www.seegene.com or call +301-762-9066.


Constantine Theodoropulos
617-816-4637

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