WASHINGTON — The National Institutes of Health on Wednesday announced a new $1.5 billion initiative to rapidly develop coronavirus diagnostics, an effort it says will result in the deployment of “millions of tests per week” by late summer or fall of this year.
The agency said the effort relies on a “national Covid-19 testing challenge” in which scientists and inventors developing coronavirus tests across the country will compete for a share of a $500 million pool earmarked for diagnostic development. Successful entrants will eventually be paired with manufacturers and business experts who can help to quickly scale up production of any tests developed during the project.
The initiative comes as numerous state governments begin efforts to reopen their economies despite a consensus among public health officials that testing capacity throughout the country, necessary to a safe reopening, is severely lacking. Covid-19, the disease caused by the novel coronavirus, has killed nearly 60,000 Americans to date.
“We need all innovators, from the basement to the boardroom, to come together to advance diagnostic technologies, no matter where they are in development,” Francis Collins, the NIH director, said in a statement. “Now is the time for that unmatched American ingenuity to bring the best and most innovative technologies forward to make testing for COVID-19 widely available.”
The NIH’s announcement marks the formal rollout of a program that federal officials alluded to last week following the controversial departure of Rick Bright, the former director of the Biomedical Advanced Research and Development Authority. Bright has since alleged he was ousted for opposing the Trump administration’s efforts to make a malaria drug available as a Covid-19 treatment despite a lack of evidence it’s effective.
Collins said Bright has been reassigned to a position as an NIH senior adviser, though his role within the RADx project is still to be determined.
“His precise role is under development,” Collins said during a conference call with reporters. “We expect Dr. Bright will find a role, also, as part of our team.”
The NIH outlined four phases in a press release: First, it will accept submissions for innovative new testing technologies, then cull the submissions in a rapid process the agency likened to the cutthroat, entrepreneurship-themed TV show “Shark Tank.” It will next conduct validations and risk assessments for the most promising entrants, and, finally, conduct clinical tests and seek regulatory approvals for the new test products before they enter mass production.
The National Institute of Biomedical Imaging and Bioengineering, one of the 27 institutes housed within NIH, will oversee the effort, led by its director Bruce Tromberg.
Tromberg said the institute expected to receive between 200 and 500 inquiries about the program, which could translate to roughly 100 applications and, down the line, roughly five “outstanding, promising” approaches that the NIH could move to commercialize.
The project will focus on tests to diagnose Covid-19 in patients who are currently sick, Collins said — not on serological tests that determine whether an individual carries antibodies that indicate they were previously infected with coronavirus.
The initiative, known as NIH Rapid Acceleration of Diagnostics, or RADx, is the second major Covid-19 initiative the NIH has announced this month. On April 17, the agency outlined a new public-private partnership with 16 pharmaceutical and biotechnology companies that aims to accelerate the development of vaccines and therapeutics to treat Covid-19.
The announcement comes less than a week after Congress passed a sweeping extension of a paycheck protection program, which included over $1 billion in funding for a new NIH effort to accelerate testing technologies.