Technology Core

Project Summary: Technology Development Core 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. This is an unprecedented time for infectious disease (ID) diagnostics. The COVID-19 pandemic and the influx of funding from the Rapid Acceleration of Diagnostics (RADxTech) has stimulated and accelerated the development of POC SARS-CoV-2 diagnostics. Some of these POC platforms could be used to detect a wide range of other ID pathogens including STI and other emerging and re-emerging infections with a relatively small additional investment. The technologic advances of the last decade have also brought new innovation that could be leveraged for infectious disease diagnostics to create POC or self-tests that could be cheaper, more robust, and faster. The JH-C[ID]2 has engaged with over 100 companies for STI and SARS- CoV-2 POC tests (POCT) and has identified common bottlenecks to development to commercialization and adoption. We have successfully moved several early-stage companies from proof-of-concept to FDA clearance. Furthermore, developers who had worked with the JH-C[ID]2 on STI diagnostics were able to pivot to SARS-CoV-2 detection as part of RADx Tech and complete development to achieve FDA emergency use authorization. With our experienced, multi-disciplinary team, the Technology Core has the following aims: 1) outreach to and calls for proposals from developers at all stages that target unmet need in infectious disease diagnostics; 2) funding for meritorious proposals with clear milestones and decision points for go/no-go decisions; 3) integrated evaluation and support from experts to decrease complexity and cost while identifying risks to success through a systems engineering approach; 4) referral to Clinical Core services and other JH- C[ID]2 resources to verify performance with clinical samples in the hands of potential users. Over the last 3 cycles and now in this cycle, we will continue to refine our development approach of multidisciplinary innovation towards value-based adoption of accessible POC infectious disease diagnostics that will have public health impact in different global settings.