The goal of this Phase II SBIR proposal is to develop SeLux?s rapid, comprehensive, low- cost, phenotypic antibiotic susceptibility test (?AST?) system through FDA 510(k) submission for fastidious bacteria and yeast. SeLux?s next-generation phenotyping (?NGP?) platform uniquely enables rapid AST with comprehensive antimicrobial menus of >50 drugs at a low cost from isolates and positive blood culture samples. NGP thus holds the promise to transform infectious disease patient care by cutting 1-2 days off the standard delay to targeted therapies.
Aim 1 will optimize NGP assays for fastidious bacteria and yeast, including CDC Urgent Threat Neisseria gonorrhoeae.
Aim 2 will optimize the NGP algorithm and scale reagents for manufacturing.
Aim 3 will comprise a 510(k) equivalence study performed at three trial and one reference site as defined by the FDA?s recent presented guidance. The proposed work builds on SeLux?s NGP development to date, which has demonstrated performance exceeding FDA requirements for all drugs tested to date with 13 major non-fastidious species. SeLux has assembled a world-class R&D team and Advisory Board and has developed the manufacturing and clinical study partnerships required for successful study completion.
The new paradigm in clinical medicine is value-based healthcare, which requires rapid and accurate diagnoses leading to optimal patient treatment. Nowhere is this more important than in treating infections, where doctors are currently forced to overprescribe broad-spectrum antibiotics during an agonizing 2-4 day wait for antimicrobial susceptibility test (?AST?) results. This proposal would develop SeLux?s novel AST platform, which uniquely enables rapid AST with comprehensive test menus, to support the testing of bacteria and yeast than currently available on any automated AST platform. This advance would be transformative for the treatment of infections because the current over-use of broad-spectrum antimicrobials not only harms individual patients but is a primary contributor to the growing epidemic of antimicrobial resistance.
