Amazon gets FDA nod on its coronavirus test
Amazon has received emergency use authorization from the Food and Drug Administration for its SARS-CoV-2 assay.
The Amazon RT-PCR test is designed to detect the virus in anterior nasal swab specimens self-collected either under the supervision of a healthcare provider or unsupervised at home. The test may be used with either individual samples or up to five pooled samples.
Amazon’s real-time test, which was developed by subsidiary STS Lab, is a modified version of BGI Genomics’ FDA-authorized RT-PCR COVID test. Seattle-based Amazon said that it intends to use the test for employees and other individuals who enter its facilities as part of its COVID-19 preparedness and response program. The test may only be used by labs designated by STS Lab that are CLIA-certified to perform high-complexity tests.
This story first appeared in our sister publication, Genomeweb.