Fast-Track proposals will be accepted. Direct to Phase II proposals will not be accepted. Number of anticipated awards: 1-2 Budget (total costs): Phase I: up to $300,000 for up to 1 year; Phase II: up to $1,500,000 for up to 3 years. Background Cases of syphilis, caused by the pathogen T. pallidum, are increasing in the US and globally. In 2018, the total number of syphilis cases (all stages) in the U.S. was the highest it had been in over 25 years. From 2017 to 2018, syphilis cases increased 13.3%, and congenital syphilis cases increased by 39.7% (CDC’s 2018 STD Surveillance Report). Current diagnostics for syphilis are inefficient, cumbersome to use, and outdated. Attempts to control or eradicate syphilis will require the development of straightforward, easy-to-use diagnostics that take advantage of modern molecular technology. Project goal The goal of this project is to develop a rapid (≤ one hour), point-of-care diagnostic capable of detecting T. pallidum directly from patient specimens. Phase I activities may include: • Development of a prototype assay that demonstrates the rapid (less than 60 minutes) detection of T. pallidum from clinical specimens • Integration of platform and assay to rapidly identify T. pallidum • Development of sample preparation methods consistent with the product platform Phase II activities may include: • Development of sample preparation methods consistent with the product platform • Further development of the prototype product to determine performance characteristics • Final validation testing and scale-up manufacturing of test kits This SBIR will not support: • The design or conduct of clinical trials; please see https://grants.nih.gov/policy/clinical-trials/definition.htm for the NIH definition of a clinical trial. For clinical trial support, please refer to the NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement program announcement or the NIAID Investigator-Initiated Clinical Trial Resources webpage.