Developing a highly sensitive, rapid, handheld vaginal swab test for the detection of Chlamydia trachomatis

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Project Summary Phase Diagnostics is aiming to create the new gold standard diagnostic for the detection of sexually transmitted infections (STIs). The company aims to replace lab-based assays for Chlamydia trachomatis (CT) and expand testing accessibility to previously unreachable settings. The technology combines the ease-of-use and very low cost of rapid point-of-care (POC) diagnostics with the very high accuracy of lab-based tests, enabling unprecedented reliability at the POC and at home. CT infection is one of the most prevalent STIs in the United States. An estimated three million new cases occur each year with direct annual medical costs of greater than $3.5 billion. Untreated CT, symptomatic or not, may cause long term pregnancy complications, even infertility. Traditional lab-based CT assays prevent the ability to test-and-treat within one patient visit. This delay results in a high number of cases that do not get treatment due to loss-to-follow up (especially for young STI patients) and increased infection transmission. Existing rapid POC diagnostics currently fail to address these problems with sensitivities less than 50%. Phase Diagnostics’ TruST, a handheld, one-step True Swab Test for CT will address the market’s demands with four key characteristics: (1) Fast: Results to the patient in less than 15 minutes; (2) Affordable: Costs less than $1 to manufacture; (3) Accurate: Sensitivity and specificity on par with lab-based assays; (4) Convenient: Handheld with no required equipment or training. TruST is one of the only products that combines the advantages of all testing options, allowing us to enter testing settings unreachable to existing diagnostics. The key innovation is to use aqueous two-phase systems (ATPSs) to selectively pre-concentrate the pathogenic bacteria prior to detection, thereby dramatically enhancing the accuracy of conventional rapid LFA POC technology and enabling the use of vaginal swabs for the detection of CT. Phase I of the project will involve developing a low risk, easier to achieve two-step device, and a high risk, high reward one-step diagnostic. We will use vaginal swab samples collected in STI clinics to evaluate the feasibility of the two approaches, and the one that achieves superior sensitivity and specificity will be further investigated in Phase II. Successful completion of Phase I will result in finalized diagnostic components for prototyping and evaluation in Phase II. Phase II of the project will consist of developing a prototype of our TruST device. Small-scale manufacturing will be established to ensure a pilot lot can be manufactured with high precision. The manufactured pilot lot will then be used for Alpha and Beta product testing where the devices will be sent to multiple clinical sites for on-site evaluation by clinicians. Successful completion of Phase II will result in a device ready for FDA 510(k) clearance and CLIA waiver-enabling clinical studies.