Since the COVID-19 pandemic began in March 2020, testing for SARS-CoV-2 was the first line of defense to slow the virus from spreading. However, since this was a novel virus, no tests existed to quickly identify people who were infected with SARS-CoV-2. So, the National Institute of Health (NIH) created the RADx consortium to quickly perform clinical trials for new SARS-CoV-2 diagnostic tests and tasked Eureka with developing the web and mobile app infrastructure to run these clinical trials.
Over the past two years, Eureka and RADx conducted 6 studies on 4 SARS-CoV-2 devices:
1. ClearDetect antigen home test from Maxim Bio.
2. Sal6830 saliva test, the nation’s first point of care PCR saliva test for COVID-19, from MicroGEM.
3. Accula accelerated PCR test from Mesa Biotech Inc.
4. Simoa antigen test from Quanterix.
All 4 devices received an Emergency Use Authorization (EUA) from the FDA. Additionally, the RADx studies have resulted in the publication of over 30 academic publications.
In total, the RADx studies enrolled over 15,000 participants. Over 1,700 of these participants participated in the Test Us Bank biorepository study in which blood, saliva, and/or nasal swab samples were collected and stored for future studies so that we will be better prepared for future obstacles that this pandemic (or future pandemics) may present us.
Since Eureka is an online platform, we had the ability to quickly enroll participants into these trials at a pace that far exceeds most traditional clinical trials. While a traditional clinical trial can hope to enroll 350 participants over the course of ~8 weeks, RADx was able to enroll the same number of participants in only 3 days! Since enrollment is online, we were able to enroll participants in remote regions of the country who may not otherwise be able to access SARS-CoV-2 tests. Additionally, the remote nature of these studies limited the amount of person-to-person contact between participants and researchers, which was of vital importance during the pandemic.
We would like to thank our collaborators at the University of Massachusetts, UMASS Lowell, Northwestern University, Johns Hopkins University, Kansas University, University of Iowa, Emory, Oregon Health and Sciences University, and all of our participants who helped accomplish these extraordinary goals.