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The platform, comprising immunoassay and chemistry analyzers, was previously cleared by the FDA, and is now available in Europe, the US, South America, and Asia. 

VisualDx, maker of an image-based clinical decision support system, has a new app to help iPhone users analyze skin lesions nearly instantaneously.

UgenTec and R-Biopharm's collaboration will cover the software's development, regulatory approval, and launch.

The test, miRpredX 31-3p, is a positive theranostic test that quantifies the expression of miR-31-3p in FFPE using RT-qPCR technology. 

The latest offering puts the genetic testing company on the path toward becoming what it calls a preventive health service company.

The company is targeting hospital labs interested in a more streamlined mass spec solution as the clinical mass spec market begins to heat up.

A technician conducting a test at Grifols' CLIA lab

The firm's president of global diagnostics marketing said that recent revenue growth comes as a result of multiple initiatives implemented in recent years.

The firm, which raised $7.1 million from its IPO last week, is looking to move into geographies where a need for infectious disease tests are already well established, its CEO said. 

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