- The Washington Times - Sunday, July 19, 2020

Americans pining for better COVID-19 tests should see relief by the fall thanks to a $500 million federal effort to deliver rapid and portable tests, including a lunchbox-sized machine that reads pop-in cartridges and sample tubes that plug into computer tablets and spit out results.

The National Institutes of Health is shepherding thousand of applicants through a “Shark Tank”-style competition that allows developers to pitch their ideas to experts and win millions of dollars in funding from the government.

The idea is to shift from a cumbersome testing system that is causing long lines and unacceptable wait times to one in which millions more people can see rapid results. The stakes are enormous, as businesses and schools clamor for easy-to-use tests and Americans dream of diagnostics that can be used at home.

The goal of the Rapid Acceleration of Diagnostics (RADx) initiative is to bolster existing testing capacity by 10% to 15% by September and make it possible to screen 2% of the U.S. population — more than 6 million people — per day by the end of the year, from RADx contributions and the continued scale-up from current manufacturers.

The U.S. is testing roughly 700,000 people per day, though experts say the U.S. needs to run at least 5 million or so daily tests to detect enough cases and isolate the infected.



“Many, many more people need to be tested. We need to have our eyes on the virus,” said Bruce Tromberg, head of the innovation segment of RADx and director of the National Institute of Biomedical Imaging and Bioengineering. “We would ideally like tests to be handheld, portable, fast, personal — so that’s what RADx Tech, in general, is designed to do.”

The U.S. is shattering daily records for new cases regularly as transmission swamps the South and West. On Friday and Saturday, reported infections topped 70,000. Hospitals in Texas and Florida are facing crunches and are worried that the crisis will exhaust their medical personnel.

The surge has resulted in testing demands that outstretch capacity at commercial labs, underscoring the demand for rapid, on-site tests like the ones run on people who get near President Trump and Vice President Mike Pence at the White House.

“The national testing scene is a complete disgrace,” Colorado Gov. Jared Polis, a Democrat, told NBC’s “Meet the Press.”

Many people report waiting up to a week for results and might be spreading the coronavirus before they get their positive result. Those who test negative won’t know whether they became infected during the wait.

“We really need to have tests that everyone can have access to over-the-counter — in convenient point-of-care locations,” Mr. Tromberg told The Washington Times.

Congress provided a half-billion dollars for NIH’s effort in a coronavirus relief package in late April.

Within five days, Mr. Tromberg’s division had tapped into a research network that develops point-of-care tests for diseases.

It received 2,600 applications upfront and has been guiding promising ideas through its “innovation funnel.” About 90 so far have made it into a “deep dive” process, in which a panel of experts peppers the developers with questions about their plans and capabilities.

They will ask things like: “How does this work, really? Did you think about the plastic in this material? Did you think about the fluidic technology and tell us how you’re going to solve this? You say you’re going to make 10 million tests a day. Well, how is that really going to happen?”

“Every aspect of your plan has to be worked out,” Mr. Tromberg said.

So far, more than two dozen developers have moved from the “deep dive” into the first phase of work that comes with $500,000 to $1 million in program support. Officials in the coming weeks will begin to move some into a second phase that is accompanied by up to tens of millions of dollars in financial support. The names of the leading companies are proprietary, so it’s unclear which are swimming the fastest through the shark tank.

The phase two process involves clinical tests, regulatory approval and the scaling of manufacturing to get tests to market.

“In just the first three months of the RADx initiative, I’ve been encouraged by the strong response we’ve seen from developers and the progress that’s underway in moving the best ideas forward,” said Sen. Roy Blunt, the Missouri Republican who championed RADx with Sen. Lamar Alexander, Tennessee Republican and chairman of the Senate Committee on Health, Education, Labor and Pensions.

“Sen. Alexander and I worked together on this initiative to rapidly accelerate the development of new testing technologies that will be critical to getting people back to school, back to work and back into the economy. We need millions of point-of-contact tests that are easily taken, widely available and provide quick results,” Mr. Blunt said.

The devices making their way through the pipeline are enticing. One example is a handheld machine that allows people to swab themselves, put the swabs into a solution and drops of that solution into a cartridge. Within 30 minutes, the machine spits out a reading that “looks like a pregnancy test.”

“It’s a little blue line that lights up, you’ve got ‘you’re positive,’ if not, you’re negative,” Mr. Tromberg said.

The upsides are clear: The machine can be used by people without special training, it’s portable and it will cost only in the hundreds of dollars.

Another promising technology is an antigen test developed by 3M and researchers at the Massachusetts Institute of Technology. The test uses small paper that works differently from ones that detect nucleic acid from the virus.

“Ours is a test for the proteins of the virus rather than its genetic material, and you don’t need to send a sample to the lab for processing,” MIT associate professor Hadley Sikes said. “Our goal is that someone with minimal training could perform the test within minutes.”

MIT reported that the NIH is supporting its test for rapid development after a RADx review by panel experts. Once validated by regulators, 3M and MIT hope to produce millions of the tests per day.

Other promising technologies under review involve mobile devices. One in development consists of a simple plastic tube that houses a sample. The tube is inserted into a modified tablet, like an iPad, which reads the results.

Mr. Tromberg’s division is one segment of the broader RADx program, which also features teams tasked with assisting underserved populations affected by COVID-19; developing novel techniques to root out the virus, such as checking community wastewater; and accelerating technologies that allow scientists to distinguish between COVID-19 and other diseases, including influenza.

Even if a COVID-19 vaccine is developed by the start of 2021, Mr. Tromberg said, it will be important to root out cases while it is distributed, differentiate COVID-19 from the flu and prepare for the next health scare.

“Distinguishing between multiple pathogens, mutations of viruses — we need to raise our game in testing, and our testing game needs to be tuned into the needs,” Mr. Tromberg said. “Clearly, we need to have our eyes on these pandemics … these pathogens, much more effectively.”

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