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Seegene Gets CE Mark for GI Infectious Disease Test

NEW YORK (GenomeWeb) – South Korea's Seegene announced on Monday that it has received CE-IVD marking for its Allplex Gastrointestinal Full Panel Assay, a multiplexed real-time PCR test for gastrointestinal infection.

The assay, which is now cleared for marketing in Europe and certain other regions, covers 25 bacterial, viral, and parasitic causes of gastrointestinal infectious disease.

"We are pleased to launch the Allplex GI assay in countries recognizing the CE mark," Seegene CEO Jong-Yoon Chun said in a statement. "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 US markets."

Earlier this year, Seegene received Canadian approval for its respiratory disease assay and US approval for its herpes simplex virus 1 and 2 assay.