In response to the FDA’s statement on at-home COVID-19 testing, Carbon Health released a statement on its website clearly outlining it was selling an at-home collection kit as opposed to an at-home test. An Everlywell media relations representative said the company is “working directly with the FDA to ensure our kits meet the regulatory requirements that apply to at-home collection kits,” and added:
Everlywell provides at-home sample collection kits for testing to be completed by our laboratory partners. Every lab that we are working with to provide COVID-19 testing has had their validation data and reports reviewed by the FDA under the Emergency Use Authorization (EUA) framework. These labs already offer other infectious disease assays, including tests for other respiratory viruses.