California-based Innova Medical Group produces millions of COVID-19 tests every day—tests that people can perform at home and that yield results in minutes.
These tests could transform the pandemic response and move us beyond the public health policy stalemate. Yet not one of them is available to Americans. Innova is exporting them to other countries because the Food and Drug Administration bans their distribution in the U.S.
“If the U.S. government today said, ‘OK, go,’ I could deliver 60 million tests before the end of February,” Innova CEO Daniel Elliott told The Hill in a piece published Feb. 11.
Elliott believes that his company can produce 5 million tests daily by the end of February, or about 150 million per month.
By way of comparison, the U.S. performed a total of just over 58 million tests during January, an average of fewer than 1.9 million daily, according to data compiled by the COVID Tracking Project. That number could rise to the tens of millions if the FDA approved the Innova test and similar products developed by other companies.
The FDA justifies its inaction by noting that rapid, home-based tests—which detect antigens produced by the virus rather than the virus itself—are less sensitive than laboratory-based PCR tests. That lower sensitivity offers some advantages. PCR tests can return positive results in people long after they pose a danger of spreading the virus to others.
And while rapid tests are more likely than PCR tests to return false negatives, that is more than offset by their volume (tens of millions of tests per day), frequency (people could test themselves multiple times) and immediacy (they return results in minutes, rather than days).
Rapid tests can help solve the problem that masking and social distancing have not: An estimated one-third of COVID-19 cases are asymptomatic, yet those cases may account for more than one-half of transmissions. Millions of people risk spreading the disease because they don’t know they have it.
Masks and distancing may reduce that risk, but they can’t eliminate it. The run-up in cases that began last fall in the U.S. and Europe occurred despite widespread mask-wearing.
The Centers for Disease Control and Prevention has never developed effective policies for identifying people who are infectious. Instead, it advises wearing a mask—or two—but has never devised an effective plan for what to do once people acquire the infection despite wearing masks.
Widespread use of rapid tests would be a critical feature of such a plan. It would replace ignorance with knowledge. Once people know they are carrying the pathogen, they can take appropriate steps to protect others.
The Biden administration has shown an openness to rapid tests but remains stymied by the FDA. The administration has contracted with a half-dozen companies to buy rapid tests, though it hasn’t disclosed which companies or whether their products have gained FDA approval.
The FDA remains the major stumbling block. President Joe Biden’s nominee for surgeon general, Dr. Vivek Murthy, recently told The New York Times that the government should begin “thinking more broadly” about COVID-19 testing.
“If you really want to empower people in a moment like this,” he said, “creating the kind of tests that people can utilize in their own homes would be a wonderful way to do that.”
Rapid at-home tests offer a new and promising policy direction. They are a complement to vaccines and a fail-safe if variants arise that the vaccines don’t prevent.
Instead of doubling down—literally—on masks, the government should pursue better ways of fighting the pandemic. Liberating and equipping Americans to use rapid at-home tests is the best place to start.
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