Seegene Receives Health Canada Approval for Its New Allplex(TM) Respiratory Molecular Test
(firmenpresse) - GAITHERSBURG, MD and SEOUL, KOREA -- (Marketwired) -- 03/02/15 -- Seegene Inc. (KOSDAQ: 096530), a leading developer of multiplex PCR technologies, today announced that Health Canada has approved its 6-target Allplex™ Respiratory Panel 5 assay, which identify Influenza virus A and B, RSV A and B, and Influenza A virus subtypes H1 and H3. Allplex™ tests are based on Seegene''s innovative MuDT™ technology enabling simultaneous detection and quantification of multiple targets in a single fluorescence channel, without melting curve analysis.
This approval further builds on Seegene''s strong and growing market presence in the Canadian molecular diagnostics market. Seegene now offers 10 multiplexed infectious disease molecular assays in Canada and is the leading provider of respiratory genotyping tests in the country with an estimated market share of more than 50%. With the newly approved Allplex™ Respiratory Panel 5 assay, Seegene intends to further penetrate into the respiratory screening market that accounts for more than 70% of the overall Canadian respiratory testing market.
This Canadian approval follows Seegene''s recent U.S. Food and Drug Administration (FDA) 510(k) clearance for its TOCE™-based assay for herpes simplex virus (HSV) types 1 and 2, its first product to clear the FDA. As part of initiatives to expand its global presence in the molecular diagnostics market Seegene will continue to pursue a series of future submissions of other Allplex™ tests for Europe, Canada and the U.S. markets.
For example, the company is on track to commercialize its Allplex™ family of infectious disease panel tests, including Allplex™ Gastrointestinal Infection (GI) Full Panels with a CE-IVD mark expected in early 2015. The Allplex™GI panels are the first high-multiplexed tests based on a real-time PCR platform that cover 26 underlying causes of gastrointestinal infectious disease. The company views this panel as a very powerful tool that offers a more comprehensive and actionable diagnosis in the gastrointestinal diagnostic space.
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.
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Contact:
Constantine Theodoropulos
(617) 816-4637
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Datum: 02.03.2015 - 08:05 Uhr
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