Three firms that rushed to market unauthorized kits for at-home coronavirus testing face new questions from lawmakers in Washington.
On Wednesday, two Home Democrats, Representatives Raja Krishnamoorthi of Illinois and Katie Porter of California, despatched letters to the chief executives of Carbon Well being, Everlywell and Nurx, asking them to elucidate their enterprise and testing practices.
The companies had marketed kits designed to permit customers to gather their very own saliva, throat swabs or deep nasal swabs at house and ship the samples to labs to be examined for the virus.
However the lawmakers famous within the letters that the Meals and Drug Administration had not approved any at-home specimen assortment kits for coronavirus testing as a result of “their accuracy has but to be clearly decided.”
The Home members additionally requested the executives, who suspended advertising and marketing the kits to the general public over the weekend, what their firms supposed to do with any cash customers had paid for the kits and testing.
“Do you propose to refund all customers all quantities they paid for at-home coronavirus take a look at kits, and in that case, when and the way you’ll you achieve this?” they wrote within the letters. Additionally they requested what the businesses supposed to do with any organic specimens that customers had despatched in for testing.
The push to promote at-home kits coincided with a push by the White Home to advertise fast innovation in coronavirus testing by enjoyable federal well being laws. However the F.D.A. warned last week that it had not approved any checks for buy by customers that concerned individuals accumulating their very own specimens at house and transport them to labs for testing.
Mr. Krishnamoorthi is chairman of the Subcommittee on Financial and Client Coverage throughout the Home Committee on Oversight and Reform. Ms. Porter sits on the subcommittee.
Within the letters, the lawmakers additionally requested the start-ups what they supposed to do with the specimen assortment swabs that they’d bought for his or her at-home kits. These merchandise have been in brief provide in lots of hospitals.
What number of “swabs does your organization possess,” the lawmakers wrote, “and can you donate them to be used with F.D.A.-approved coronavirus checks?”
The businesses all stated this week that they’d labored with accredited labs that had acquired F.D.A. authorization to carry out coronavirus testing and had adopted federal requirements for establishing the accuracy of their coronavirus checks.
Carbon Well being, which provides telemedicine consultations and operates clinics in California and Nevada, stated it had refunded the cash to individuals who had purchased its kits and supplied them in-person testing for the virus at its clinics.
Everlywell, which promoted its at-home package final week as a client product, stated in a press release that it had not bought any of the kits to customers and was now offering the take a look at supplies “at value to hospitals and well being care organizations who can decide to offering the take a look at without cost to their staff and sufferers.”
Nurx didn’t instantly reply to a request for remark.