Pressure rises for rapid COVID-19 testing

The Trump administration’s Operation Warp Speed has now helped achieve the remarkable success of two vaccines shown to be highly effective in preventing COVID-19. But pressure is rising for a similar push from the administration in a different area key to fighting the pandemic: rapid testing. 

Despite the success with vaccines, they will not be widely available to the general public for several months, even as hospitalizations and deaths continue to spike heading into a brutal winter. 

A vocal group of experts say that widespread rapid testing could help drastically slow the spread of the virus until a vaccine is widely available, and help open businesses and schools. 

But such tests have not gotten off the ground, despite the technology existing. Backers point to regulatory barriers at the Food and Drug Administration (FDA) and a lack of government investment in ramping up manufacturing of the tests to the millions per day that would be needed. 

President-elect Joe Biden is calling for stronger government action. In a speech in October, he called for a “faster, cheaper screening test, that you can take right at home or in school,” and his transition team’s coronavirus plan includes a call to “invest in next-generation testing, including at home tests and instant tests, so we can scale up our testing capacity by orders of magnitude.”

President Trump, in contrast, has frequently downplayed the need for more testing. 

“We have leadership in the country, [and] they don’t realize they’re leaders,” said Michael Mina, a professor at the Harvard T.H. Chan School of Public Health who has been advocating for rapid tests for months. “The number of people I’ve talked to who say, ‘Well, why isn’t this happening?’ and my only answer is, ‘Because you’re not doing it.’ ”

The tests Mina and others are pushing for are simple paper strips that could be mass-produced so that every household in the U.S. could have a supply, and use them multiple times per week. Someone could know whether they are positive for coronavirus by whether a line shows up on the paper strip or not, within minutes. 

That way, before going to work or school, or a gathering of friends, people would know whether they are positive, and if they are, they could stay home. 

“The government should be sending those out with surgical masks to every household in the US,” said Eric Topol, a professor of molecular medicine at Scripps Research. 

Anthony Fauci, the government’s top infectious diseases expert, made a nod to such rapid at-home tests while speaking to a New York Times summit Tuesday. 

“What we really need now and we hopefully will get, but we don’t have it yet, is point of care testing that people can essentially do at home, like a pregnancy test, because the spread is community spread from people without symptoms,” Fauci said. 

Not everyone is fully on board, though, including, crucially, the FDA. 

Some experts raise concerns that the rapid tests are not as accurate as the standard tests currently being relied on, and that people could get a false negative from a rapid test and then go out and infect others. Another concern is that if people are taking tests at home, they will not be reporting their results to public health authorities, and the country will lose out on data on where the virus is spreading. 

“There’s been a discussion of lowering standards to bring something to market, and that I’m not in agreement with,” said Peter Lurie, president of the Center for Science in the Public Interest and a former associate commissioner of the FDA. 

An FDA spokesperson pointed to an op-ed in The Hill that two top agency officials wrote in September, which included a warning about the danger of lower accuracy tests giving false negatives. 

“You might be falsely assured that your symptoms are just a summer cold,” wrote the FDA officials, Jeffrey Shuren and Timothy Stenzel. “You go about your normal day and then put everyone you encounter at risk of infection.”

Still, they added that they are willing to listen to new ideas. “FDA is always open to alternative proposals from developers and will continue to consider those,” they wrote.

Backers of the rapid tests say the FDA is taking too narrow of a view, and that when rapid tests are used frequently on a wide scale they will help catch many more cases than a smaller number of somewhat more-accurate tests would. Backers also say the rapid tests are accurate in catching positive cases when it matters most, when people are most infectious and at risk of spreading the virus to others.   

Topol said he thinks the FDA is being “absurdly, inappropriately overcautious” in approving rapid tests. 

The FDA did take a step forward Tuesday when it authorized the first at-home test. But the test, from a startup company called Lucira, is more complicated than a simple paper strip, meaning it will cost about $50, and will not be widely available until the spring. 

Mina said the government needs to take a far more active role in providing funding to ramp up manufacturing of rapid tests, rather than relying on small startup companies to do the work themselves. He estimates the cost of a nationwide rapid testing program would be about $30 billion, a small fraction of the multiple trillions Congress has spent on economic relief from the coronavirus crisis. 

“It’s pausing our society, and yet we’re sitting here actually having a discussion, clapping about a very small startup company getting a new product on the market that will be available in April,” Mina said. 

“These tests could have allowed Thanksgiving to happen normally had we started this in August,” he added.  

Rahul Dhanda, CEO of Sherlock Biosciences, another company working on a rapid test, said his company could ramp up faster with government funding. 

“We could do a lot more at-risk earlier, if there was government support for the work that we and others are doing,” he said.