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CE mark

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.

The lung cancer test, which can detect 51 EGFR mutations, is the fifth assay for cancer that the Belgian molecular diagnostics firm has CE marked.

The test is the first offered for the Sgx Clarity system, a fully automated in vitro diagnostic platform leveraging single-molecule counting technology.

The BRCA Mastr Plus Dx assay and Mastr Reporter software identifies mutations in the coding regions of the BRCA1 and BRCA2 genes

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The former commissioner of the FDA has returned to the venture capital firm New Enterprise Associates as a special partner on the healthcare investment team.

Astronauts have edited yeast genes on the International Space Station in an experiment designed to show how cells repair themselves in space.

Emory University has found that two of its researchers failed to divulge they had received funds from China, according to the Atlanta Journal-Constitution.

In Science this week: influence of the nuclear genome on human mitochondrial DNA, and more.