BARDA Announces the 68th FDA Approval/Licensure/Clearance for Medical Countermeasures Supported by BARDA Under Novel Public Private Partnerships

At BARDA, we are excited about the recent U.S. Food and Drug Administration (FDA) 510(k) clearance of the first assay panel for use with the Selux Next Generation Phenotyping (NGP) System, from our partner Selux Diagnostics. The Selux Gram-Positive Panel is an in-vitro antimicrobial resistance test that can determine a bacteria’s susceptibility to 14 specific antimicrobial agents. The Selux NGP System is a rapid antibiotic susceptibility testing (AST) platform that provides targeted therapeutic results in less than 6 hours from isolated colonies, faster than the current standard of care for most clinically significant aerobic microorganisms. Same-day shift results will allow clinicians to make treatment decisions 1-3 days earlier. The system is an easy-to-use, automated, high-throughput phenotypic test that uses proprietary metabolic and cellular morphology measurements paired with machine-learning algorithms to produce accurate antibiotic susceptibility test results. Future generations of the platform are being designed to enable testing directly from positive blood cultures and shorten the total test time from 36 hours to less than 16 hours from whole blood collection.