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Selux Diagnostics Nabs FDA 510(k) for Drug Resistance Panel

NEW YORK – The US Food and Drug Administration said it granted 510(k) clearance last week for a Gram-negative antimicrobial susceptibility panel on Selux Diagnostics' Next Generation Phenotyping System for rapid AST.

The agency gave the go-ahead on April 19 for the Selux Gram-Negative Panel, which adds 23 Gram-negative antimicrobial targets to the firm's antimicrobial susceptibility testing platform. The panel is designed for use with Selux's phenotyping system for antibiotic susceptibility testing, which the agency cleared in January along with the Selux Gram-Positive Panel.

The Boston-based firm said in an announcement that the panel informs personalized antibiotic therapy and returns results in 5.5 hours from isolated colonies.

Selux CEO Steve Lufkin said the panel's clearance brings the firm closer to combating the surge in antibiotic resistant superbugs. 

"As bacteria are becoming more resistant to antibiotics, laboratories need an AST platform that can keep pace with current breakpoints and [have] room to grow as new drugs come on the market," he said in a statement. "The ability to receive same-shift results combined with a comprehensive antibiotic menu should save lives, shorten hospital stays, and combat antimicrobial resistance."

The firm said the clearances granted by the FDA include a Breakpoint Change Protocol that lets the company rapidly update breakpoints and ensure the panel results are up-to-date and that they meet College of American Pathologist requirements.

FDA officials said in a separate announcement that the firm's two antibiotic resistance panels cleared this year allow for simultaneous testing of a larger number of drugs and drug concentrations than previous systems and the firm's panels can be expanded to incorporate additional drugs.

The previously cleared Selux Gram-Positive Panel determines susceptibility to 14 antimicrobials.