The U.S. National Institutes of Health (NIH) today announced a $1.5 billion initiative to speed breakthroughs in diagnostic tests for the virus that causes COVID-19. The program aims to increase the U.S. capacity for SARS-CoV-2 testing up to 100-fold by late summer, in time for the start of the flu season.
NIH Director Francis Collins said during a conference call with reporters that the improved tests are desperately needed to deal with the global pandemic, at least until an effective vaccine is rolled out. "These technologies will play a pivotal role in getting us back to normal," Collins said.
The effort, known as Rapid Acceleration of Diagnostics (RADx), will use a network of existing NIH-sponsored diagnostic development centers to evaluate proposals. The network will pair approved teams with experts in technology, regulatory approval, commercialization, and manufacturing to speed their progress. Proposals can use any technology to detect an active infection and will be evaluated for their likely success in improving testing performance—qualities such as speed, reliability, and accuracy—and ease of use, such as detecting the virus in saliva or exhaled breath.
NIH is already accepting proposals and expects to approve roughly 100 diagnostics projects for up to three rounds of development, officials said during today's call. NIH anticipates backing a handful of those projects to full commercial development.
The agency is styling the competition for funds after Shark Tank, a reality TV show that pairs aspiring entrepreneurs with business experts to evaluate and advise them on their proposals. But not all diagnostics experts agree that the reality TV approach is what's needed. "We have enough testing platforms," says Alan Wells, a diagnostics expert at the University of Pittsburgh Medical Center. "The problem is the supply chain is screwed up," which prevents labs from getting enough chemical reagents to run their labs at full capacity. Wells adds that it's unrealistic to expect a new technology to go from concept to validation and scale-up in a few months. "I don't care how much money you give me I'm not going to have 10 million tests a week by November."
U.S. labs now perform about 1.5 million coronavirus tests per week. The mainstay of current testing is a technology known as reverse transcriptase polymerase chain reaction (RT-PCR), which amplifies viral genetic material to make it easier to detect. Once a sample is in a PCR machine, the test is highly accurate at pinpointing the virus. But in many cases, the nasal swabs used to collect samples fail to capture viral material, leading to as many as 30% of people who have the virus being diagnosed as not having it. Transporting the tests to testing centers and running the test can also take days, meaning people who eventually test positive may unknowingly infect other people while waiting for results.
To make millions of tests available per week, the NIH project is agnostic about technology. Several technologies are being developed to try to get around PCR's issues. Several companies are trying to detect viral proteins known as antigens. Antigen tests are in widespread use for detecting infections such as strep throat. But so far, efforts have been hampered by difficulty finding a protein target unique to SARS-CoV-2, and challenges in detecting low amounts of the virus. Another option under development uses the genome editor known as CRISPR to detect snippets of viral RNA unique to SARS-CoV-2. Early studies suggest the approach is just as accurate as RT-PCR, but the technology faces hurdles in validating the tests in real-world conditions and scaling up manufacturing.
Collins says that's where RADx may help. Accepted proposals will be paired with project development and commercialization experts, and NIH will supply the funding, partnerships, and other resources to deploy successful tests in the shortest possible timeline. Money for the new program was included in the $484 billion coronavirus relief package Congress passed last week. "This is an effort to do at an unprecedented scale and speed what the world is waiting for," Collins says. And if it's successful, improved diagnostics technology will likely not only help with the current pandemic, but with future infectious disease outbreaks as well.
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