Lawmakers Question Start-Ups on At-Home Kits for Coronavirus Testing
The makers of unauthorized kits designed for consumers to collect their own saliva or throat swabs faced scrutiny from Congress.
Three companies that rushed to market unauthorized kits for at-home coronavirus testing face new questions from lawmakers in Washington.
On Wednesday, two House Democrats, Representatives Raja Krishnamoorthi of Illinois and Katie Porter of California, sent letters to the chief executives of Carbon Health, Everlywell and Nurx, asking them to explain their business and testing practices.
The companies had marketed kits designed to allow consumers to collect their own saliva, throat swabs or deep nasal swabs at home and send the samples to labs to be tested for the virus.
But the lawmakers noted in the letters that the Food and Drug Administration had not authorized any at-home specimen collection kits for coronavirus testing because “their accuracy has yet to be clearly determined.”
The House members also asked the executives, who suspended marketing the kits to the public over the weekend, what their companies intended to do with any money consumers had paid for the kits and testing.
“Do you intend to refund all consumers all amounts they paid for at-home coronavirus test kits, and if so, when and how you will you do so?” they wrote in the letters. They also asked what the companies intended to do with any biological specimens that users had sent in for testing.
The rush to sell at-home kits coincided with a push by the White House to promote rapid innovation in coronavirus testing by relaxing federal health regulations. But the F.D.A. warned last week that it had not authorized any tests for purchase by consumers that involved people collecting their own specimens at home and shipping them to labs for testing.
Mr. Krishnamoorthi is chairman of the Subcommittee on Economic and Consumer Policy within the House Committee on Oversight and Reform. Ms. Porter sits on the subcommittee.
In the letters, the lawmakers also asked the start-ups what they intended to do with the specimen collection swabs that they had purchased for their at-home kits. Those products have been in short supply in many hospitals.
How many “swabs does your company possess,” the lawmakers wrote, “and will you donate them for use with F.D.A.-approved coronavirus tests?”
The companies all said this week that they had worked with accredited labs that had received F.D.A. authorization to perform coronavirus testing and had followed federal standards for establishing the accuracy of their coronavirus tests.
Carbon Health, which offers telemedicine consultations and operates clinics in California and Nevada, said it had refunded the money to people who had bought its kits and offered them in-person testing for the virus at its clinics.
Everlywell, which promoted its at-home kit last week as a consumer product, said in a statement that it had not sold any of the kits to consumers and was now providing the test materials “at cost to hospitals and health care organizations who can commit to providing the test for free to their workers and patients.”
Nurx did not immediately respond to a request for comment.