CE mark

The company's antibiotic-induced hearing loss test will be used to screen babies for a genetic mutation that can cause deafness when given certain antibiotics.

The T2Resistance Panel, which runs on the T2Dx instrument, detects 13 genes conferring antimicrobial resistance directly from whole blood in three to five hours.

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.

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.

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 test is the first near-patient assay for M. genitalium, and can also guide treatment by detecting antibacterial resistance markers.