Amazon subsidiary STS Lab Holdco received FDA emergency use authorization (EUA) for the direct-to-consumer sale of its COVID-19 test.
The FDA authorized the test with indications as a direct-to-consumer product for testing individual anterior nasal swab specimens self-collected at home with the Amazon COVID-19 test collection kit DTC by any individual 18 years or older, according to an FDA letter.
STS Lab Holdco previously won EUA in March for the real-time PCR test without the direct-to-consumer sale option. The current indication includes those without symptoms or other reasons to suspect COVID-19 infection and is limited to authorized laboratories.
Authorization extends to pooled samples containing up to five individual anterior nasal swab specimens per pool that are self-collected in individual vials containing transport medium, the letter reads.
Test results from specimens collected with the Amazon COVID-19 test collection kit DTC can be delivered to the user online through Amazon’s diagnostics website (amazondx.com), while users also receive email and text message notifications to alert them to when results are available.
