Amazon wins EUA to sell its COVID-19 test directly to consumers

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 deli…

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Amazon company gains EUA for COVID test

Amazon subsidiary STS Lab Holdco received FDA emergency use authorization (EUA) for its real-time PCR test for COVID-19.

According to an FDA letter, dated March 25, the test is authorized for the detection of nucleic acid from SARS-CoV-2 in anterior nasal swab specimens that are self-collected by any individuals 18 or older, including those without symptoms or other reasons to suspect COVID-19 infection.

Samples can be collected with Amazon’s test kit either under the supervision of a healthcare provider or unsupervised at home, as well.

The authorization also extends to pooled samples containing up to five individual anterior nasal swab specimens per pool that are self-collected with the Amazon COVID-19 collection kit under the supervision of a healthcare provider.

Testing with the Amazon collection kit is limited to certified laboratories that can perform high complexity tests and are designated by STS Lab Holdco. The kit includes a nasal …

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