The goal of this Phase I SBIR proposal is to demonstrate utility to all major pathogenic bacterial strains of SeLux?s rapid, low-cost, phenotypic antibiotic susceptibility test (AST) system (fast-AST or FAST). Utilizing existing optical detectors and standard dried antibiotic microplates, and avoiding pitfalls of metabolic probes, FAST will potentially transform therapy of infections by significantly accelerating AST, thereby facilitating treatment with the optimal antibiotic.
Aim 1 will apply FAST to hundreds of samples of pathogenic bacterial strains, while developing and optimizing a predictive algorithm for clinical utility.
Aim 2 will extend the FAST platform to slow-growing strains and species as well. SeLux has demonstrated FAST to exceed FDA 510(k) requirements for minimum inhibitory concentration determinations for 25+ strains of Staphylococcus aureus and Escherichia coli with full antibiotic panels. Completion of the proposed aims will expand FAST to all major clinically-relevant, non-fastidious bacterial pathogens. SeLux?s interdisciplinary team has expertise in nanosensing, microbiology, and algorithm design and is buttressed by distinguished experts in Clinical Microbiology, Infectious Disease, and Machine Learning.

Public Health Relevance

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 48+ hour wait for antibiotic susceptibility test (AST) results. The novel, rapid, low-cost AST platform described in this proposal promises to reduce this delay in treatment by as much as 30 hours. This advance would be transformative for the treatment of infections because current over-use of broad-spectrum antibiotics not only harms individual patients but is a primary contributor to the growing epidemic of antibiotic resistance.

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
Project #
1R43AI136125-01
Application #
9464993
Study Section
Special Emphasis Panel (ZRG1)
Program Officer
Ritchie, Alec
Project Start
2018-01-01
Project End
2018-12-31
Budget Start
2018-01-01
Budget End
2018-12-31
Support Year
1
Fiscal Year
2018
Total Cost
Indirect Cost
Name
Selux Diagnostics, Inc.
Department
Type
DUNS #
079715313
City
Cambridge
State
MA
Country
United States
Zip Code