AUSTIN, Texas – An Austin-based medical diagnostics company that planned to release testing kits for the coronavirus this week directly to consumers has been forced to delay those plans, the Austin-American Statesman reported.
Everlywell last week said it would start selling the self-administered tests beginning Monday. But the U.S. Food and Drug Administration announced that it had not "authorized any test that is available to purchase for testing yourself at home for COVID-19."
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Everlywell CEO Julia Cheek said the company had been under the impression that its new kits would not be in conflict with FDA regulations. The test will now only be available to "qualifying hospitals and healthcare companies who can commit to providing the test for free to healthcare workers and high-risk, symptomatic patients affected by the testing shortage,” the company said on its website.
You can read more about this story on the Austin-American Statesman website.
COVID-19, the respiratory disease caused by the new virus, stands for coronavirus disease 2019. The disease first appeared in late 2019 in Wuhan, China, but spread around the world in early 2020, causing the World Health Organization to declare a pandemic in March.
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