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Roche received several clearances, including for its Cobas CT/NG assay and for modifications to previously cleared blood clotting systems.

The Bologna workflow was developed to accelerate identification and treatment selection of bloodstream infections.

The company said the FDA has cleared use of the company's mass spec-based MALDI Biotyper system for the detection of Candida auris.

A brief recap of Diagnostics news the week of Ma4r 23, 2018: Bruker, T2 Biosystems, Philips, Meridian Bioscience, Agilent, Biotechnology Industry Research Assistance Council, Becton Dickinson, Strata Oncology.

Exosome Diagnostics said this week that it has expanded the coverage of its ExoDx Prostate IntelliScore (EPI) cancer test to an additional 82 million covered lives in the US, bringing the total to about 100 million.

Researchers found that 98 percent of the identifications the system provided were correct, indicating the usefulness of the platform in clinical mycology.

Merlin will become Bruker's Center of Excellence for specialty and selected antibiotic-resistance and -susceptibility testing. 

The immunoassay-based device, called the portable Bio-Detector integrated, can detect up to six organisms or toxins per assay chip in around 20 minutes.

The platform received 510(k) clearance from the US Food and Drug Administration for the expanded identification of mycobacteria, Nocardia, and molds.

The new version of the mass spectrometry-based system adds 144 microbial species to its database and includes new tools for sample preparation.

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