Oxis International (US) gets drug resistance test approval:
This article was originally published in Clinica
Executive Summary
Oxis International (US) has gained US FDA 510(k) approval for its bacterial antibiotic resistance assay, beta-lactamase rapid enzyme-detection disc. The beta-L-Red discs use Oxis' proprietary compound, cefesone, to detect the production of beta lactamase, one of the most common resistance mechanisms. The company says the discs can detect resistance in 15 seconds to an hour, compared with 24 hours for microbiology-lab testing.