The FDA has allowed the first stand-alone home tests for coronavirus. They can be used at home without a doctor’s prescription.
Everlywell was one of the companies that began work on a standalone home coronavirus diagnostic kit. After development, engineers sent a request to the U.S. Food and Drug Administration (FDA) to ensure proper emergency use of their kits before shipping them to consumers. Now the US regulator has allowed them to be used without the intervention of a doctor.
This is the first standalone sample collection kit to receive permission to use. Other kits were used only with the prescription of a doctor. Everlywell permission is unique because the company offers its own kit that can be tested in any testing laboratory – this will make testing more universal.
This data is now also available to other companies wishing to develop similar test suites, the FDA said. In the future, this will speed up tests and eliminate additional bureaucracy. It can also make testing more extensive – many experts are sure that this is an important part of the fight against the coronavirus pandemic.
“The authorization of a home-test kit that can be used with many tests in most laboratories is an important step in increasing the number of studies,” said Jeffrey Schuren, MD, FDA Center. “This is a great example of a public-private partnership in which industry research used data from a private study to tackle the epidemic”.