11 Accelerating Diagnostic Innovation for Pandemic Control

Any serious outbreak of a novel infectious disease requires rapid innovation in testing technologies that can efficiently and accurately screen and diagnose active infection on both the individual and population levels. Delays in diagnostic testing imperil containment of an outbreak and delay control of a pandemic. In response to the dearth of diagnostics for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at the outset of the coronavirus disease 2019 (COVID-19) pandemic, the U.S. National Institutes of Health (NIH) launched the Rapid Acceleration of Diagnostics (RADx) initiative. RADx comprises a suite of programs to support the development, production scale-up, and deployment of SARS-CoV-2 tests across the country. RADx helped create a diagnostic testing ecosystem that is dynamic, distributed, and accessible, and that extends diagnostic testing to the point of care (POC) and into homes, schools, and places of business. This chapter describes the approach and lessons learned through one of the components of RADx, RADx Technology, that sped innovation in the development, commercialization, and implementation of COVID-19 testing. RADx Tech, led by the NIH National Institute of Biomedical Imaging and Bioengineering (NIBIB), used an innovation funnel methodology to compress the diagnostic technology development timeline from years to months. This was accomplished by employing expert teams in parallel to address technical, regulatory, clinical, and commercialization requirements and to support the validation, de-risking, scale-up, manufacturing, and deployment of novel SARS-CoV-2 tests. RADx Tech and its partner programs enabled dozens of testing technologies to obtain regulatory authorization, delivered billions of tests into the market, and catalyzed a fundamental shift toward the acceptance and widespread use of self-testing. This program represents a new paradigm by which the NIH, and the federal government writ large, can catalyze medical technology development during a public health emergency.