Public hunts coronavirus tests, FDA warns new at-home kits ‘unauthorized’

As a wave of at-home tests for coronavirus are coming on the market, federal regulators issued stern guidance saying that none of them has yet been approved for use and warning consumers to be wary of “unauthorized fraudulent test kits.”
Hours after STAT reported on Friday that at least four startups would roll out at-home tests over the next week, the Food and Drug Administration released a statement saying: “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.”
Experts told STAT that the new tests may not meet the FDA’s high standards for traditional approval and that consumers risk not getting an accurate result if they don’t swab deep enough in their nose or throat. But the companies defend the at-home tests and insist they are permitted under government rules loosened to expand desperately needed testing for Covid-19, the disease caused by the new coronavirus.

The guidelines for coronavirus testing have been shifting rapidly, and in some cases the wording of the new rules appear to be in conflict — leading to different interpretations.
In revised regulations issued on Feb. 29 and March 16, the FDA sought to make it easier for certain companies to make new coronavirus tests under what is known as an Emergency Use Authorization (EUA). Those guidelines — specifically for public health emergencies — are aimed at allowing companies with previously approved tests to begin using them to detect coronavirus. But at-home tests were excluded from this rule.

Within the new guidelines, however, was another stipulation: Any lab that had been certified under quality-control standards known as CLIA could start performing coronavirus tests. The agency did not specify whether this portion of the guidelines applied to at-home tests. And some of the startups launching these tests are using CLIA-certified labs to do so.
In a White House press conference on March 16, Admiral Brett Giroir, assistant secretary for health, spoke about the rules.

“There are also a whole growth of what’s called laboratory-determined testing or laboratory-derived testing, where individual laboratories, because of the regulatory de-regulation of the FDA, can develop their own tests and start using them,” Admiral Giroir said. “So if you’re a CLIA-certified lab with complexity, you can do that.”
The startups appear to have believed that, under the new rules, they were in the clear to go ahead with coronavirus tests so long as they were using a CLIA-certified lab to process the results.
San Francisco-based telehealth startup Nurx is one of the startups starting to sell an at-home coronavirus test. On Twitter on Friday, Nurx’ CEO Varsha Rao said, “I’m excited to share that @nurxapp has introduced the first #COVID19 home test kit & online consultation service. Our patients’ health is the most important priority, it would have been impossible to sit on the sidelines and watch this pandemic unfold.”

As far as whether Nurx’s test has federal regulatory approval or not, Nurx and the FDA disagree.
“Prior to a few days ago, the FDA was requiring an EUA,” Chris Hall, senior clinical adviser to Nurx, told STAT on Friday. “A few days ago, FDA eased that, so that an EUA is no longer required. So as long as [a lab] is compliant with CLIA, they are free to use that test.”
On Saturday in an emailed statement sent to STAT, Nurx re-emphasized that stance. In addition to having a test “validated in accordance with the FDA’s Emergency Use Authorization policy,” Nurx’s test is processed by a lab located in Washington state, which appears to give coronavirus test manufacturers even more flexibility to sell their tests, the company said.
Primary care startup Carbon Health, which rolled out an at-home test on Friday, appears to be taking a similar position.
“We support what the FDA has stated. Our test is for at-home collection and the testing occurs at a state-licensed CLIA complex lab under the direction of a physician,” Caesar Djavaherian, the company’s co-founder and medical director, said in an email on Sunday. “This is completely in line with what we are doing. We agree that no one should use the nefarious at-home tests that are not ordered by doctors and are marketed directly to patients.”
An FDA official, speaking on background Saturday, said the FDA’s position is that what matters in the new guidelines is that they exclude at-home tests. Whether or not the companies use CLIA-certified labs to process the results is apparently not important.
That would mean that none of the at-home tests being developed by startups is permitted, including ones already being sold by companies including Carbon Health and Nurx.
“The FDA will take appropriate action to protect consumers from bad actors who take advantage of a crisis to deceive the public by marketing tests that pose risks to patient health,” the FDA’s Friday statement read. “This may include issuing warning letters, seizures or injunctions.”

As public hungers for coronavirus tests, FDA warns new at-home kits are ‘unauthorized’