The U.S. National Institutes of Health has put out the call for innovators — from the basement to the boardroom — to compete for a share of a $500 million prize in a contest to develop at-home and point-of-care diagnostic tests for COVID-19.
The NIH is using a competitive model based on ABC's reality TV show "Shark Tank," where a panel of entrepreneurial investors — sharks — decide if they want to fund an innovator's product.
Sens. Lamar Alexander, R-Tenn., chairman of the Senate Health, Education, Labor and Pensions Committee, and Roy Blunt, R-Mo., chairman of the Appropriations Committee's Labor, Health and Human Services, Education and Related Agencies Subcommittee, had proposed using the Shark Tank idea to accelerate the development of COVID-19 tests in an April 20 op-ed in The Washington Post.
"If there's a bold idea out there that will work, we need to make sure the funding is available to get it approved and in the hands of health-care providers quickly," the senators wrote.
On April 29, Alexander said he plans to convene his Senate committee May 7 to discuss COVID-19 testing and the NIH's Shark Tank-like initiative.
The finalists in the NIH's Rapid Acceleration of Diagnostics — RADx — challenge will be matched with technical, business and manufacturing experts, the agency's director, Francis Collins, told reporters April 29.
If certain selected technologies are already relatively far along in development, they can be put on a separate track and be immediately advanced to the appropriate step in the commercialization process, he said.
The NIH is spending $1.5 billion overall on the RADx initiative, which will coincide with a newly formed public-private partnership between the federal government and 16 biopharmaceutical manufacturers to accelerate the development of drugs and vaccines for COVID-19, Collins noted.
The funding for the RADx initiative is coming from the $484 billion Paycheck Protection Program and Health Care Enhancement Act, signed into law on April 24, he said.
"This is going to be development on a whole new scale, both in terms of the way in which we are doing this to try to achieve a large increase in testing capacity, but also the speed with which we're trying to achieve it," the NIH chief said. "This is an incredibly bold and somewhat unprecedented initiative, but we are determined to do everything we can to push it forward."
The NIH is soliciting applications from scientists and engineers who have developed novel technology platforms for detection of the coronavirus, he said.
"We'll bring them into a shark tank — at least it's like a shark tank — to assess their potential for rapid scale-up," Collins said. "We're relying on the unique and legendary American ingenuity to come through for us here."
Collins noted the NIH is working with the U.S. Food and Drug Administration, the Centers for Disease Control and Prevention and the Biomedical Advanced Research and Development Authority, or BARDA, on the initiative.
"And we will need to have partnerships with the private sector — both large and small — in order for this kind of effort to succeed," he said.
Ex-BARDA chief's role
The Trump administration had first revealed the RADx project was in the works when it confirmed April 21 that Rick Bright had been abruptly removed from his position as BARDA director and transferred to the NIH to work on developing point-of-care testing platforms under the planned initiative.
The next day, Bright said his involuntary removal from the BARDA post came after he had complained about the Trump administration's pursuit of unproven drugs to treat COVID-19, such as hydroxychloroquine and chloroquine.
Bright's lawyers said the action was out of "retaliation plain and simple," and on April 23, said they planned to file a whistleblower complaint.
On the April 29 call with reporters, Collins said Bright "has been assigned to the NIH as a senior adviser to me in this area of diagnostics for COVID-19. His precise role with RADx is under development."
Bruce Tromberg, director of the NIH's National Institute of Biomedical Imaging and Bioengineering, is in the lead role in running the RADx initiative's competition, Collins said.
"We expect Dr. Bright will find a role also as part of our team," the NIH chief added.