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US FDA Remains Concerned About OTC Access To COVID-19 Tests After It Allows First 'At-Home' Use

 
• By Malcolm Spicer

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.

Riga, Latvia - April 8 2020: Coronavirus SARS-CoV-2 testing at home. COVID-19 Rapid test cassette for coronavirus. Man holding a rapid testing kits. Man reading a manual how to do a Test at home

Making available in the US "at-home" COVID-19 tests is getting as much attention lately as the virus itself, most recently with the announcement of an emergency use authorization of a serological test consumers can access through doctors' referrals.

Also recently, French pharma giant Sanofi revealed a partnership with a Silicon Valley startup on developing a smartphone app...

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