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CE mark

The test is the second infectious disease assay from Bioneer to be CE marked, and the South Korean company has a third test in the pipeline.

The tubes and collection kits meet the requirements of the European In-Vitro Diagnostic Devices Directive, and the company can now commercialize the devices throughout Europe.

The firm said that receipt of the CE mark accelerates its entry into the diagnostic pathology market in Europe and other key geographies globally.

Eurobio Scientific will also develop new test kits for the T-COR 8, a real-time PCR thermocycler originally developed for the US Army.

The test is the latest in a series of CE-IVD-marked assays the company has launched for use on Becton Dickinson's PCR-based BD Max platform.

The firm said that its newly CE-marked test for intestinal infections is suitable for use in laboratories and hospitals, and provides results in 90 minutes.

With the significant overhaul of the European regulatory landscape underway, some fear it may disproportionately affect small and medium-sized IVD companies.

 

The firm said it anticipates launching the platform in Europe next year and completing its first round of external financing in the first quarter of 2020.

The Simplexa VZV Swab Direct runs on the firm's Liason MDX instrument and has also been submitted to the US Food and Drug Administration.

The company said its APAS Independence platform can process 200 culture plates per hour and automatically remove nonsignificant plates from the workflow. 

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