The US Food and Drug Administration (FDA) has warned American companies against shipping at-home coronavirus testing kits, despite relaxing its approval process for diagnostics for the virus sweeping the nation and globe.
It comes after several companies, including Silicon Valley biotech start-ups like Nurx and Carbon Health began developing their own at-home sample collection sets. Nurx had even shipped a number of its products.
Start-ups like these jumped at the chance to began producing simpler, cheaper and more convenient tests amid the coronavirus crisis and in the wake of the Centers for Disease Control and Prevention’s (CDC) own bungled testing roll-out.
But experts worry that these at-home tests may be less accurate and that companies making them may simply be trying to to take advantage of a public health emergency to turn a quick profit.
Many, including President Donald Trump, have complained that the gold standard test requires an uncomfortable swabbing process, conducted by a health care professional, so the FDA has relaxed its guidelines to allow self-swabbing.
It clarified Monday, however, that that change does not extend to at-home testing.
At-home sexual health testing start-up Nurx announced Friday that it had developed a home COVID-19 test (pictured) – but had to shut down sales after the FDA’s Wednesday night warning that its relaxed approval regulations did not apply to home test kits
Last Monday, the FDA took the unprecedented step of allowing states to green-light coronavirus tests without its approval in an effort to speed testing and slow the spread of COVID-19 in the US.
By Friday afternoon, at-home sexual health testing start-up Nurx had announced its at home test kits were ready to ship.
CEO Varsha Rao promised 10,000 tests were ready to be provided ‘over the following weeks,’ and that more than 100,000 would be on their way ‘in the new future.’
It promised the tests ‘at cost,’ for a total of $181 for consultation, the test kit and shipping.
Later Friday the company pressed pause on the roll out of its tests.
And Friday evening the FDA sent out its alert that it had not authorized any at-home testing for COVID-19.
‘We want to alert the American public that, at this time, the FDA has not authorized any test that is available to purchase for testing yourself at home for COVID-19,’ said Commissioner Dr Stephen Hahn in a statement.
‘The FDA sees the public health value in expanding the availability of COVID-19 testing through safe and accurate tests that may include home collection, and we are actively working with test developers in this space.’
Everlywell made waves when it began selling its $135 at-home test kits, but it will have to wait for FDA approval to begin distributing the tests
That stopped companies like Nurx, as well as Carbon Health – an online health tool that promised it was also going to ship thousands of test kits in coming weeks – and Everlywell in their tracks.
Everlywell, based in Texas, had promised a $135 at-home test to start shipping on Monday, but it will now be waiting for FDA approval.
Washington state has introduced the Greater Seattle Coronavirus Assessment Network (SCAN) to monitor the virus’s spread based on results from home test kits. It’s unclear what will become of the network in light of the FDA’s warning.
LifeHope Labs in Georgia began shipping its own at-home kits directly to consumers week before last, but was warned against doing so by the Georgia government, and then partnered with doctors who prescribed the tests.
By Friday, the company said it had already run 100 tests.
The original US test, put out by the CDC was much like a flu test, but required a somewhat invasive and uncomfortable process. A health care professional uses a swab akin to an extra long Q-tip to swipe a sample from the back of a patient’s throat via their nostril.
Seattle initiated a coronavirus monitoring network based on at-home test kits (pictured). It’s unclear what will become of the endeavor in light of the FDA’s warning
Many at-home testing kits offer more shallow nasal swabs, oral swabs or cheek swabs.
The appeal is a more comfortable patient experience – both in terms of the procedure itself and in the environment in which people take the test.
But experts warn warn these disparate ways of collecting specimens may yield inconsistent and less accurate results.
‘There are significant differences between these collection methods,’ commented Dr Dan Wattendorf of the Bill and Melinda Gates Foundation on the charity’s website.
‘So it’s essential for the FDA to evaluate their relative performance through rigorous, well-designed studies.’
However, the Gates Foundation itself is researching the efficacy of these tests in the hopes that they may eventually help expand testing in the US.
President Trump on Monday announced that self-swabbing was coming, causing some confusion.
It’s not clear what test he was referring to, but the FDA has cleared the way for samples to be collected by patients using a Q-tip-like medical swab that doesn’t have to go so far into the nostril.
That doesn’t mean they can do the tests at home, but will mean a less unpleasant testing experience, and will help limit the exposure of health care workers to coronavirus.
FDA officials have approved a test made by Cepheid, that will return results within about 45 minutes, meaning it can be run at a health care clinic, and patients can receive their results before leaving the location.