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NIH Opens Covid-19 Diagnostic Test Challenge

Nurse at a Covid-19 drive-in testing site in New Jersey (Master Sgt. Matt Hecht, NationalGuard.mil)

30 Apr. 2020. National Institutes of Health began a competition for new diagnostic tests that can better determine the extent of Covid-19 infections in the U.S. The NIH challenge, called Rapid Acceleration of Diagnostics, or RADx, is funded by $1.5 billion in recent stimulus legislation that calls for the U.S. government to develop a comprehensive Covid-19 testing strategy.

RADx aims to find the best candidates for point-of-care and at-home Covid-19 diagnostics that can translate into large numbers of inexpensive and easy-to-use tests, in a relatively short period of time. The challenge is a three-phase competition starting with an open call for technologies from a wide range of participants, for a $500 million purse. Initial proposals will be evaluated for technical, clinical, commercial, and regulatory issues, with the most promising entries passing into the second round. Selection of teams from the second phase for the final round is expected to occur during the summer of 2020.

NIH says teams selected for the second round will receive their own budgets, deliverables, and deadlines, and be matched with technical, business, and manufacturing experts to fine-tune their ideas, which will be assessed for moving in the final round. The goal of the final round for each competitor is full clinical deployment of the team’s diagnostic test, on an accelerated schedule. Those entries already well along in development will be evaluated on a separate track to reflect their stage in the commercialization process.

“Americans are innovators and makers,” says Bruce Tromberg, director of National Institute of Biomedical Imaging and Bioengineering, or NIBIB, in an NIH statement. “We need American tech experts, innovators, and entrepreneurs to step up to one of the toughest challenges we’ve faced as a country, to help get us safely back to public spaces.”

NIBIB is overseeing the RADx challenge. Experts from the Point-of-Care Technology Research Network, a group established by NIBIB, will be the judges and advisors to competitors. That network is made up five technology hubs around the U.S.: Emory University and Georgia Institute of Technology in Atlanta; Johns Hopkins University in Baltimore; Northwestern University in Evanston, Illinois; University of Massachusetts Medical School in Worcester; and Consortia for Improving Medicine with Innovation and Technology at Harvard Medical School and Massachusetts General Hospital in Boston.

“If all goes well,” says NIH director Francis Collins in an agency blog post, “RADx aims to support innovative technologies that will make millions more rapid SARS-CoV-2 tests available to Americans by late summer or fall. Such widespread testing, which will facilitate the speedy identification and quarantine of infected individuals and their contacts, will likely be a critical component of making it possible for Americans to get safely back into public spaces, including returning to work and school.”

RADx is now accepting proposals from challenge participants, but has not given deadlines or firm schedules for the three phases. Science & Enterprise asked NIH for that timetable and will update this story accordingly.

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