CE mark

T2 said that the panel will be commercially available in Europe in Q3, and added that it is in the midst of completing a pivotal trial in preparation of a submission to the FDA.

NGeneBio is moving ahead with plans to have the test cleared for diagnostic use in Korea, while envisioning a 2019 submission to the US FDA.

The test, which is currently for research use only, uses fluorescent multiplex PCR to co-amplify seven markers for analysis of the MSI-high phenotype.

The Korean molecular diagnostics startup is planning to launch the new offering in Europe, as well as China and other Southeast Asian countries.

With CE marking for the gram-positive and gram-negative panels, the firm has achieved the designation for its family of three ePlex bloodstream infection assays.

The company launched the MassArray System with Chip Prep Module in Europe for general IVD use, targeting hospitals and laboratories. 

The firm said that its Panther Fusion system expands molecular testing capabilities, and increases productivity and flexibility for labs.

The firm's real-time PCR assay for rapid detection and differentiation of novovirus genogroup I and II runs on the Aries sample-to-answer system. 

The test, designed to simultaneously detect diarrhea-causing enteric viruses using DNA extracted from a stool sample, includes norovirus GI, norovirus GII, and others. 

The firm will encounter stiff competition, particularly from BioMérieux and Luminex, but there are untapped opportunities for adoption, according to industry analysts.

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