The Food and Drug Administration on Wednesday opened the door to COVID-19 testing that could be fast, cheap, and handled entirely at home — if companies don’t find the rules too burdensome.
Routine screening of people who don’t know they have COVID-19 could transform the fight against the disease.
“These types of tests will be a game-changer in our fight against COVID-19 and will be crucial as the nation looks toward reopening,” FDA Commissioner Dr. Stephen Hahn said in a statement announcing how the agency will approve at-home tests.
So far, the FDA hasn’t allowed anyone to sell tests for at-home use.
Lab tests to detect the coronavirus are accurate, but they’re often restricted to people who have COVID-19 symptoms. It often takes days to get results — by which point the person may have already infected others.
Other tests are fast, but so expensive they’re unlikely to be used regularly. A clinic in Massachusetts, for example, charges $160 per rapid test; it’s not covered by insurance.
With COVID-19, people are most contagious in the few days before they develop symptoms and as symptoms first develop.
Screening at home, maybe once or twice a week, would allow people to test themselves before going to work or school, getting on an airplane, attending an event, or visiting an elderly relative. Letting people know they are infectious in real-time would enable them to self-quarantine, and it would allow others to go about day-to-day life without risk of infecting others.
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Will FDA rules encourage or discourage companies to create at-home tests?
Several testing experts, including Dan Larremore of the University of Colorado, said the FDA’s move is a step in the right direction and could encourage companies to pursue inexpensive, rapid, at-home tests.
But Dr. Michael Mina, an infectious disease epidemiologist at the Harvard T.H. Chan School of Public Health, said the way the FDA’s guidance template is written makes it less likely that such crucial tests will reach the general public.
The template spells out how a sample is to be collected and analyzed and how results are to be shown to a user without the need to send a sample to a lab for analysis.
The template also outlines how accurate the tests must be, with slightly lower standards than lab-based tests.
“The [required] software alone will pose an incredibly large hurdle for many,” Mina said via email. “Unfortunately the template does not offer this type of ‘new’ avenue that I think is going to be necessary if we want to see truly $1 daily tests become a reality.”
Mina said the standards should be lowered further. People are contagious only when there’s an extremely high virus level in their body, which can be detected by a less sensitive test. An infection that goes undetected by a less-sensitive test would be caught a few days later when the person is tested again, he said. Or the person would already be on the way to recovery and probably wouldn’t be contagious.
Similar rapid tests used to diagnose strep throat miss as many as one in five people who are infected, so physicians normally send a throat culture to a lab to confirm the diagnosis, said Dr. Emily Volk, president-elect of the College of American Pathologists. Such confirmatory testing usually takes several days.
If that were done with COVID-19, it could add to the delays of traditional testing rather than relieve them.
A race to create a fast, cheap COVID-19 test
There are several tests close to market that are fast and relatively cheap, but none meets Mina’s vision: A rapid test that costs as little as $1 and can provide an answer before someone leaves the house in the morning.
The XPRIZE, a nonprofit that designs and hosts public competitions, announced Tuesday it would split a $5 million prize among five winners who can produce a test that delivers results in as little as 15 minutes and costs less than $15.
Another $50 million is available to scale up manufacturing and could be distributed to any contestant during the competition, said Jeff Huber, president and cofounder of OpenCovidScreen, whose company is launching the competition in collaboration with XPRIZE.
The competition is open until the end of August. About 200 semifinalists will be selected. They’ll be winnowed to 20 finalists and then five winners.
Contenders will have to meet criteria that will speed up FDA approval. They’ll get expert advice from large-scale testing companies, Huber said. The five winners will be ready to scale up manufacturing by the end of the year, he said.
Fertility doctors develop test for coronavirus
In another approach to innovative testing, Sorrento Therapeutics of San Diego has licensed technology developed at Columbia University in New York City.
Dr. Zev Williams, director of the Columbia University Fertility Center, has spent years developing tests to help couples with genetic diseases or repeat miscarriages have healthy babies. Early in the pandemic, Williams said his team concluded that finding the genetic signature of the virus that causes COVID-19 wasn’t all that different.
The technology they’ve developed essentially looks for that genetic signature in a saliva sample. The sample is put into a container with enzymes that, when heated, turn the liquid red to indicate no virus present or yellow to show an infection. The test is as accurate as the current standard, called a PCR test, which relies on expensive, lab-based machines, said Henry Ji, Sorrento’s CEO and cofounder.
The company expects the test, which has not yet received FDA approval, to cost around $10, said Mark Brunswick, the company’s senior vice president of regulatory affairs.
Test company official: FDA has ‘moved the goalposts’
In a third approach, Intrivo Diagnostics of Santa Monica, California, and Access Bio of Somerset, New Jersey, are collaborating to design and distribute a rapid at-home test. Dr. Michael Harbour, chief medical officer of Intrivo, said he expects to complete the FDA approval process in the next 90 days.
Their test provides a finger-pricking device and analyzes a drop of blood. A blue line would indicate a positive for the virus; no line would be an all-clear.
The test should be accurate enough to meet the FDA guidelines, Harbour said. The companies are prepared to conduct trials, as required by the FDA, to make sure the test is easy enough for most people to use. He said he did not know how much it would cost.
The FDA, Harbour said, has “moved the goalposts” several times, requiring testing companies to follow one protocol and then another. But he’s hopeful that it’s now clear how important this type of test will be to keep the virus under control.
“If the FDA is smart,” he said, “they are going to work quickly to make these available.”
Contact Karen Weintraub at [email protected]
Ken Alltucker contributed to this story.
Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.
This article originally appeared on USA TODAY: COVID test: FDA opens door to rapid, cheap, at-home screening