By foreseeing the need — and cutting through the red tape at the FDA — an Julia Cheek of Everlywell brought coronavirus home tests to market.
was due to confusion in the interpretation of FDA guidelines. The good news was that the FDA did see the public health value in the tests and wanted to work with companies. Everlywell worked with the FDA to secure an Emergency Use Authorization for its kits before sending any to consumers.
"The authorization of a COVID-19 at-home collection kit that can be used with multiple tests at multiple labs not only provides increased patient access to tests but also protects others from potential exposure," Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, said in a statement.
For now, Everlywell charges for its home test but makes no profit. However, the company is working with insurance companies to get the test covered and with Congress to make the test free. During the eight weeks Ong was working with the FDA on approval for the company's COVID-19 test, Everlywell implemented work-from-home procedures and cut all discretionary spending. It also provided tests to healthcare and frontline workers.
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