US Market For OTC COVID-19 Tests Transitions From Unmet Demand To Multiple Choices
Abbott’s’s distribution of its BinaxNOW COVID-19 Ag Self Test to US retailers increases to three the number of OTC tests for the virus that CVS offers, along with Ellume’s and Labcorp’s test kits also available under EUAs granted by FDA.
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Anytime COVID Test marketed home-use test without FDA approval or EUA and promoted it with an FDA logo and a “clinical trial number.” Warning letter says “your presentation conveys the misimpression that the product has been approved, cleared, authorized, endorsed or otherwise evaluated by FDA.”
“We see this is a as a significant opportunity, and quite frankly, a trend that's been happening overseas and is kind of now happening here in the US,” says Abbott Labs CEO Robert Ford.
Five firms' “representations create a false impression that [their] products have been authorized for emergency use by FDA and are misleading," states FDA's medical device center.