After scrutinizing several dozen submissions to its national, “Shark Tank”-esque pitch competition for new COVID-19 diagnostics technologies, the National Institutes of Health has selected its first seven projects that will move on to a new phase of manufacturing and scale-up—and has unlocked nearly a quarter of a billion dollars for the effort.
The NIH’s Rapid Acceleration of Diagnostics initiative, or RADx, was first launched in late April, with the goal of providing millions of new coronavirus tests to the public by September. This includes high-throughput laboratory hardware capable of processing hundreds of samples per day as well as smaller machines designed for rapid testing in the field.
After winnowing down more than 650 applications, the most promising 100 were put through a one-week assessment of their technology and feasibility. Thirty-one made the cut, and entered what the NIH described as Phase 1: four to six weeks of deeper validation work and risk reviews.
Now the program has its first graduates to Phase 2, its final series of evaluations before deployment, which includes clinical trials, fast-tracked regulatory approvals and $248.7 million in new funding.
“These technologies will help deliver faster results from labs and more and more test results within minutes at the point of care, which is especially important for settings like schools and nursing homes,” HHS Secretary Alex Azar said in a statement.
Of the seven tests, three focus on providing in-person results in under a half-hour: Mesa Biotech’s hand-held Accula test, with a single-use, RT-PCR cartridge; Quidel’s Sofia antigen test kit, as an electronic, lateral flow immunoassay; and Talis Biomedical’s Talis One viral RNA test, employing loop-mediated isothermal amplification, or LAMP.
The other four are made for the lab. Ginkgo Bioworks’ aims to scale up its operations to provide 50,000 tests per day in September and 100,000 per day before the end of the year.
Helix OpCo plans to ship bulk, standardized kits for the collection of nasal swabs by public health departments, healthcare systems and employers, to help shepherd tens of thousands of samples to labs for processing.
Meanwhile, Fluidigm will primarily focus on saliva-based samples, using its microfluidic chip platform. It aims to provide tens to hundreds of thousands of new tests per day this fall.
Finally, Mammoth Biosciences looks to wield CRISPR technology to provide a simple, faster coronavirus lab test compared to typical PCR diagnostics. Co-founded by genome editing pioneer Jennifer Doudna, the company was also recently tapped by GlaxoSmithKline to develop a hand-held diagnostic.
“This is an exciting milestone,” said Bruce Tromberg, director of the NIH’s National Institute of Biomedical Imaging and Bioengineering, who helps lead parts of the RADx program. “It will help increase U.S. testing capacity exponentially. Game-changing technologies emerging from our RADx pipeline will inform public health measures to stop the spread of the virus and leave us better equipped to address future pathogens and other diseases.”
Quidel, Helix and Mesa’s tests have previously received Emergency Use Authorizations from the FDA for COVID-19; the other four currently have applications pending. The agency has been working with the NIH and RADx to advise companies on test validation and is prioritizing their reviews.
“The RADx initiative has enabled some of the nation’s most creative biomedical device inventors to ramp up development of their testing technologies at unprecedented speed,” said NIH Director Francis Collins. “The innovations selected to date represent the diverse types of promising technologies that will serve the nation’s testing needs.”
More than 20 companies are still engaged in RADx’s Phase 1, and will be considered for Phase 2 awards in the coming weeks, according to the NIH, with dozens more still moving through the funnel behind them.