US FDA Grants Three OTC Covid-19 Test EUAs Following Template Updates To Spur Development
Access Bio’s CareStart COVID-19 Antigen test gives results within 10 minutes, Becton, Dickinson’s BD Veritor within 15 minutes and InBios International’s SCoV-2 Ag Detect within 20 minutes.
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A controversial Trump-era policy that blocked the US FDA from regulating laboratory-developed tests was binned by the Health and Human Services secretary on 15 November. As a result, the FDA will once again require emergency use authorizations or other clearances for new COVID-19 tests.
The US FDA’s most recent update is intended to help test makers provide validation data and other information to the agency for developing at-home diagnostic tests.
OTC access to any test to diagnose COVID-19 without supervision by a health care professional isn't on the near-term horizon for potential launches in the US. In addition to diagnostic kits, digital apps available to directly to consumers for COVID-19 testing on their own would face a steep climb to approval.