A quiet healthcare revolution is taking place, driven by an urgent national need and fueled by cutting-edge technologies. Prior to the COVID-19 pandemic, in vitro diagnostic tests were primarily confined to laboratories, required days to return results, and were designed to evaluate the presence of disease in symptomatic individuals. Today, laboratory tests are just part of a diverse landscape of accurate, reliable, and accessible SARS-CoV2 tests, designed not just for detecting disease in individuals, but also for screening and surveillance in large populations.  Diagnostics have changed, and more COVID-19 tests are now performed in point of care (POC) and home settings than in central labs.  Looking forward, our goal is to leverage this unprecedented transformation into a new, modernized infrastructure that helps us realize the promise of personalized medicine, not just for COVID 19, but for the entire spectrum of pathogens and diseases.

Looking back on lessons learned

The Rapid Acceleration of Diagnostics (RADx^SM) initiative was launched just one year ago to expand SARS-CoV2 testing capacity, performance, and access. As the 2020 quarantine dragged on for many, behind the scenes of RADx it seemed there weren’t enough hours in the day. All those hours dedicated by more than 900 individuals in government, academia, and the private sector have helped advise and support about 150 companies over the past year.  Currently, 32 companies have progressed through the development pipeline to help produce approximately 300 million COVID-19 tests and supplies.

A “Shark-tank-like” innovation funnel forms the core of the RADx Tech milestone-driven review process that compresses the typical technology development cycle from years to months. Early on in the RADx program, lab-based technologies were prioritized to quickly increase the U.S. COVID-19 testing capacity.  Simultaneously, portable devices and mobile labs that were in late stages of development were supported to make testing more accessible at the “point of care”.   More recently, low-cost, rapid tests have emerged from the RADx development funnel and are soon to be widely available over the counter.

With COVID-19 cases continuing to rise worldwide, testing will remain critical to stem virus transmission even as more people are vaccinated. Antigen tests can be brought into households to increase the frequency and ease of testing and screening. A study supported by RADx shows that regular sequential antigen testing, two to three times per week, is as effective as a single RT-PCR test for detecting individuals infected with SARS-CoV-2. Several at-home tests now have over-the-counter Emergency Use Authorization from the U.S. Food and Drug Administration, with more in the pipeline.

A community health initiative launched by the Centers for Disease Control and Prevention and NIH is delivering a RADx Tech product – Quidel QuickVue – into participating households for free in two U.S. counties for one month. Participating individuals self-administer the tests three times a week for a month. NIH is monitoring COVID-19 transmission in the communities via publicly available case data, hospitalization rates, and sewage wastewater testing to measure the effectiveness of at-home screening for reduced community spread.

A vision for diagnostics and beyond

Accessible tests will continue to expand and become transformational tools that impact nearly every aspect of healthcare. Additionally, digital health platforms must be modernized in order to seamlessly link convenient home and POC test results to patients, healthcare providers, and public health systems. The bottom line – RADx is a new model for innovation and collaboration between government, academia,  and the private sector.   We look forward to building on these experiences as we strive to realize NIBIB’s long-term vision, “Engineering the Future of Health”.