Next-generation phenotypic antimicrobial susceptibility test platform: rapid results and comprehensive menus

下一代表型抗菌药物敏感性测试平台：快速结果和全面的菜单

基本信息

批准号：
9892951
负责人：
ERIC STERN
金额：
$ 100万
依托单位：
SELUX DIAGNOSTICS, INC.
依托单位国家：
美国
项目类别：
财政年份：
2018
资助国家：
美国
起止时间：
2018-03-14 至 2021-02-28
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9892951
关键词：
Address Agreement Algorithms Antibiotic Resistance Antibiotic susceptibility Antibiotics Antimicrobial Resistance Antimicrobial susceptibility Award Bacteria Biological Assay Blood Burkholderia Candida Categories Centers for Disease Control and Prevention (U.S.)Clinical Clinical Medicine Clinical Research Communicable Diseases Development Devices Epidemic Funding Funding Agency Generations Goals Gold Haemophilus influenzae Haemophilus parainfluenzae Healthcare Hospital Costs Infection Laboratories Methods Neisseria gonorrhoeae Organism Patient Care Patient-Focused Outcomes Patients Performance Pharmaceutical Preparations Phase Phenotype Positioning Attribute Reagent Reference Standards Reproducibility S Phase Sampling Site Small Business Innovation Research Grant Speed Stenotrophomonas maltophilia Streptococcus System Testing United States National Institutes of Health Work Yeasts accurate diagnosis algorithm development antimicrobial assay development base cost design drug testing improved individual patient next generation novel pathogenic bacteria prototype rapid diagnosis research and development resistant strain targeted treatment

项目摘要

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.

第二阶段 SBIR 提案的目标是开发 SeLux 的快速、全面、低功耗成本，通过 FDA 510(k) 的表型抗生素敏感性测试 (“AST”) 系统提交 SeLux 的下一代表型分析（“NGP”）。平台独特地支持快速 AST，同时提供超过 50 种药物的全面抗菌菜单分离株和阳性血培养样本的低成本因此有望实现。将标准延迟时间缩短 1-2 天，以实现目标，从而改变传染病患者的护理目标 1 将优化针对挑剔细菌和酵母（包括 CDC）的 NGP 检测。紧急威胁淋病奈瑟菌目标 2 将优化 NGP 算法和规模。目标 3 将包括在 3 小时进行的 510(k) 等效性研究。 FDA 最近提出的指南中定义的试验和一个参考站点。这项工作建立在 SeLux 迄今为止的 NGP 开发之上，该开发已经展示了性能迄今为止，FDA 对 13 个主要非挑剔物种的所有测试药物均超出了要求。 SeLux 组建了世界一流的研发团队和顾问委员会，并开发了成功完成研究所需的制造和临床研究合作伙伴关系。