Bruker

In the last year, both Sciex and Thermo Fisher have launched clinical platforms, but whether they will prove commercial successes remains to be seen.

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.

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.

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