The COVID-19 pandemic caused unprecedented loss as it swept through humanity wiping out 6.69 million human lives. It is now estimated that 660 million of the world’s population was infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the novel coronavirus that emerged in Wuhan, China, and then rapidly spread across continents. This is our story of how we came together during an incredibly challenging time to fight a common enemy. Times of crisis can often serve as strong drivers of creativity and innovation. It was during the crisis of the pandemic that the National Institutes of Health (NIH) launched the Rapid Acceleration of Diagnostics (RADx®) initiative to accelerate the translation of innovation into high-performing diagnostic tests. This book chronicles the power of innovating during a crisis, the compression of product launch timelines from over five years to under a year, the birth of creative financing ventures, the commitment of entrepreneurs, and the agility and resourcefulness of government institutions as they adapted to meet the imminent needs of the pandemic and serve the community. It is our sincere hope that the lessons learned from the trenches will improve our nation’s ability to fight the next pandemic.

Rapid Acceleration of Diagnostics (RADx®) Tech was the key diagnostics component of a three-pronged national strategy, including vaccines and therapeutics, to respond to the COVID-19 pandemic. Unprecedented in the scale of its mission, its budget, its accelerated time frame, the extent of cross-government agency collaboration and information exchange, and the blending of business, academic, and investment best practices, RAD Tech successfully launched dozens of US Food and Drug Administration Emergency Use Authorization diagnostic tests, established a new model for rapidly translating diagnostic tests from the laboratory to the marketplace, and accelerated public acceptance of home-based diagnostic tests. This chapter provides an overview of the processes utilized by RADx Tech during the COVID-19 pandemic to improve clinical laboratory tests and identify, evaluate, support, validate, and commercialize innovative point-of-care and home-based tests that directly detected the presence of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus.