Overall Project Summary The long-term goal of the Johns Hopkins Center for Innovative Diagnostics for Infectious Diseases JH-C[ID]2 is to accelerate infectious disease diagnostic point-of-care (POC) technology innovation and access to impact global public health. Sexually transmitted infections (STIs) and other emerging and re-emerging infectious diseases continue to threaten human health. Syndrome-based empiric algorithmic treatment protocols are widely used since diagnostic test results are often not available as actionable data during a clinical encounter. Since the clinical presentations of many infectious diseases overlap, these protocols often miss asymptomatic infection and/or result in antibiotic overtreatment, which contributes to emerging antimicrobial resistance. There is thus an unmet need for POC and at home infectious disease diagnostics; timely and actionable diagnostic data will increase the number of patients who are diagnosed and appropriately treated at POC in both the US and in RLS. COVID-19 and the Rapid Acceleration of Diagnostics Technology (RADx Tech) Program rapidly increased the number of platforms and tests available and led to a paradigm shift from centralized labs to POC and self-tests. The JH-C[ID]2 is well-positioned to continue to catalyze the successful development of POC and OTC assays for STIs, as well as emerging and re-emerging infections. As the oldest, well-established POCTRN Center, we will apply the lessons learned from the last 3 cycles to: 1) support the rapid development, commercialization, and implementation of innovative POC and self-tests for STIs and emerging and re-emerging infection; 2) develop and expand existing POC COVID-19 platforms toward the diagnosis of STIs and other infectious diseases; and 3) implement functioning core components (Administrative, Dissemination, Clinical, and Technology) to work smoothly and collaboratively to solicit and support technology that fulfills unmet needs. We have an innovative, cost-conscious approach that matches devices with the appropriate clinical context and use case for impactful adoption. With resources from the Center, devices move rapidly along the development pipeline with clear milestones where go/no-go decisions can be made regarding viability and fitness for use case and value-based adoption. The JH-C[ID]2 has had a strong track record of supporting both STI and COVID-19 POC and self-tests that have achieved FDA clearance and Emergency Use Authorization; our clinical sites allow for real-world clinical studies to assess how POCT might perform in various operating environments. Our clinical and diagnostic development expertise and approach identify key risk factors to success. Using our network, we aim to promote the development of accessible infectious disease diagnostics through multidisciplinary innovation along the development pipeline from research to impactful use in different global settings.

NARRATIVE Point-of Care tests (POCT) to rapidly and accurately diagnose infectious diseases including sexually transmitted infections (STIs) and other emerging and re-emerging infections will impact global public health and improve outcomes. Our goal is to accelerate the development of affordable POCT innovation.