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The U.S. Food and Administration has shut down sales of at-home coronavirus kits, according to USA Today.
Critics caution these tests might be unreliable, while those in favor say the test kits could save valuable time and resources. But for the time being, companies involved in manufacturing at-home test kits are cooling their heels.
That is because the FDA sprang into action March 20 when several startup companies began selling the at-home kit and ordered them to stop. The agency called the kits “fraudulent.”
“Fraudulent health claims, tests, and products can pose serious health risks,” said the agency in a statement. “They may keep some patients from seeking care or delay necessary medical treatment.”
According to USA Today, Julia Cheek, the founder of Everlywell, who gained fame from pitching her company on Shark Tank, the ABC reality show, said her at-home coronavirus test was sanctioned with an emergency waiver from the FDA to use unapproved tests. The FDA denied her claim.
Two other companies who planned to sell at-home kits, Nurx and Carbon Health, were also targeted. All three were asked by government officials to send refunds to their customers and destroy any samples.
One advocate for at-home test kits is billionaire Bill Gates, according to USA Today. He is helping to fund the Seattle Coronavirus Assessment Network or SCAN. SCAN has received approval for at-home test kits from the Washington Department of Health, but a spokesman clarified SCAN is not a clinical service but will use its data for research.
According to ABC News, the benefits of home testing kits could be substantial, allowing people to test themselves for COVID-19 instead of having to go to a medical facility and potentially increasing the risk of exposure to health-care workers.
After the FDA pronouncement, companies that had been ramping up at-home COVID-19 test put the brakes on production.
According to ABC, the FDA admits safe and accurate home tests would expand the availability of COVID-19 testing. The agency says it is working with test developers so COVID-19 collection kits might in fact reach a person’s front door in the near future.
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