WASHINGTON (Gray DC) - In a matter of weeks, you could test yourself for coronavirus at home and have results in minutes. But, some leading experts worry the government is standing in the way of better results.
A quick swab, 15 minutes, and you could get a reliable coronavirus check without leaving your kitchen. F.D.A. Commissioner Dr. Stephen Hahn says two recently approved at-home tests are critical as the country waits on vaccines to be widely available.
“We’ve got a ways to go before we get to herd immunity,” he said, “so we’re going to have to take these sort of measures to get us to the best possible place so that we can get back to some sense of normalcy.”
A test manufactured by Ellume should be available over the counter in January for about $30 dollars a pop. The test is approved for at home use without a prescription or consult with a doctor. It’s designed to connect with your smartphone, reporting results to the patient and health officials.
Abbott’s BiNaxNOW just got the greenlight for use outside clinical settings. The U.S. government previously purchased tens of millions of the test and distributed them to states.
While Hahn touts unprecedented development speed -- describing approval of the two tests within less than a year as, “truly remarkable,” Harvard Epidemiologist Dr. Michael Mina said the tests, as approved, are unnecessarily complex and expensive.
“I’m frustrated that we still don’t have this very simple device,” said Mina holding two paper strip test components, “or this one.”
Mina argues simplicity and affordability are key to near daily testing, and spotting infections before they’re spread. The F.D.A. highlighted the accuracy of Ellume and Abbott rapid tests when compared to DNA tests analyzed in labs.
Mina has also argued that test sensitivity is secondary to frequency and fast results. He said he is encouraged that the F.D.A.’s approval of an over-the-counter test may signal a willingness to remove doctors from the testing process.
In a recent interview, he argued tests doesn’t need ‘smart features’ like Bluetooth in Ellume’s test, and Abbott’s $25-test would cost less than five if it didn’t require digital house calls.
“It doesn’t make sense,” he said, “you’re essentially paying $20 just to have somebody watch you swab your nose.”
When asked about Mina’s critiques, Hahn said there is room for flexibility when it comes to sensitivity, but said pushed back on the suggestion that his agency has been overly cautious. He pointed out, regulators can only approve or block a product, they can’t change a producer’s proposal. “We accept applications,” he said, “we’re not the ones who develop the test.”
If Congress or the White House gave them that power, Mina argues the country might already have the tools it needs to escape the pandemic.