STI NG Plus, a Swab to Answer Molecular Panel Test for Point of Care Diagnosis and Treatment Recommendation

ABSTRACT The need to develop sensitive, specific, and more easily available point-of-care technologies for diagnosing STIs is critical. Many countries, including the US, have seen a sharp increase in the incidence of STIs over the past half-decade, and especially since 2020. Many cases go undiagnosed and untreated, and 30% of patients may never get treatment after testing positive. Some of these STIs have the potential to cause serious health problems, including infertility, especially if not diagnosed and treated early. Stigma, privacy, and confidentiality issues make STIs optimal areas for POC tests at healthcare facilities, as they can reduce loss to follow-up, increase patient and partner treatment rates, and avoid the use of unnecessary antibiotic treatment. The company has developed a Molecular Point of Care platform, the AmplifiDxTM DX-1000, which is capable of rapid, molecular testing using direct swabs as the sample type. The system has five optical channels, allowing detection of up to 4 infectious targets plus an internal control. The DX-1000 is differentiated and well-suited for the infectious disease testing market. The chemistry is multiplexed and sensitive, yet simple, allowing for a miniaturized product that will be attractive in the point-of-care space. The workflow is easy - one-step, swab to answer - and does not require complex mixing of reagents or handling of multiple stages of the process. Lab- quality results will be delivers in as little as 30 minutes for COVID-19. 20 minutes are possible for DNA parameters as the number of assay steps can be less. The sleek cartridge and instrument are designed for low- cost manufacturing. AmplifiDx is poised to submit a first Emergency Use Authorization (EUA) to the FDA for a COVID-19 diagnostic, which is the basis for the proposed assay for STIs and relevant resistance markers. We propose the development of an assay which will detect Chlamydia trachomatis (CT) and Neisseria gonorrhea (NG), as well as mutations associated with antibiotic resistance or susceptibility in NG. We also propose the development of a urine collection device that fits easily in to the existing workflow, to give doctors the choice of another sample type. This assay, which will be used with urogenital swabs or urine samples on the DX-1000 device and cartridge, will provide quick, actionable diagnosis for CT and NG at point of care, as well as guiding treatment decisions and promoting antibiotic stewardship by identifying antibiotic-related mutations.