PA21259, SBIR, Phase I, Development of a rapid, direct from blood, phenotypic antimicrobial susceptibility assay
PA21259,SBIR,第一阶段,开发快速、直接来自血液的表型抗菌药物敏感性测定
基本信息
- 批准号:10602780
- 负责人:
- 金额:$ 30.65万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2023
- 资助国家:美国
- 起止时间:2023-09-30 至 2024-08-29
- 项目状态:已结题
- 来源:
- 关键词:
项目摘要
PROJECT SUMMARY
Early treatment with effective antibiotics significantly improves clinical outcomes associated with bloodstream
infection. However, the phenotypic antimicrobial susceptibility tests (AST) required to choose the right antibiotics
take 4-24 hours (often longer in practice) following a 24–48-hour culture, which significantly exceeds the window
within which treatment must begin to avoid mortality. The only FDA-cleared rapid AST takes 7 hours; however,
it can only be used on a single patient sample following culture and is prohibitively expensive for many
institutions, limiting its broad adoption and reducing its clinical impact. Thus, there is an urgent need for a scalable
and affordable phenotypic AST that can quickly obtain the drug-resistance profile for microbial pathogens directly
from blood, without first requiring a long culturing step. Aincobio is developing a novel phenotypic AST, AST-
Shift, that applies macro-and microscale physics to exploit the biophysical properties of microbes to detect
response to antimicrobials within one hour following pathogen identification. The AST-Shift device will be an
automated, culture-independent, easy-to-use benchtop instrument that will produce a quantitative analysis of
antimicrobial response. It is broadly applicable to all bacterial and fungal pathogens, is compatible with
downstream applications such as subculture or molecular analysis, and has a small footprint. This Phase I aims
to demonstrate proof-of-concept that Aincobio’s AST assay can rapidly and accurately analyze whole blood
samples to report on drug-resistance profiles for a number of pathogens (gram-negative, gram-positive, and
fungi) treated with different classes of antimicrobial drugs that target bacterial cell walls (vancomycin and
meropenem), protein synthesis (linezolid, a bacteriostatic drug), DNA synthesis (ciprofloxacin), and fungal cell
walls (flucanozale) and membrane (micafungin). Successful completion of Phase I will de-risk a Phase II project
focused on producing single-use multi-well test devices, building a mechanical optical system capable of
automatically imaging pathogens in 48 different drug dose channels in parallel, and correlating AST-Shift results
with established CLSI clinical breakpoints of ESKAPE and other common pathogens to support a validation
study prior to regulatory submission. By reducing the time to phenotypic AST results of confirmed infection we
will reduce the time to targeted treatment, with the possibility of enabling truly transformative results when
combined with future culture-independent rapid pathogen detection and ID technologies. Aincobio’s simple, cost-
effective device will empower physicians with rapid and actionable data to support targeted treatment and
improve antimicrobial stewardship efforts.
项目总结
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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Lorenzo Damico其他文献
Lorenzo Damico的其他文献
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{{ truncateString('Lorenzo Damico', 18)}}的其他基金
A scalable electrokinetic flow cytometer and cell sorter
可扩展的动电流式细胞仪和细胞分选仪
- 批准号:
10546934 - 财政年份:2022
- 资助金额:
$ 30.65万 - 项目类别:
Rapid and automated detection of bloodborne pathogens for improved treatment and antimicrobial stewardship
快速自动检测血源性病原体,以改善治疗和抗菌管理
- 批准号:
10546973 - 财政年份:2022
- 资助金额:
$ 30.65万 - 项目类别:
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