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March 29, 2021 02:12 PM

Amazon gets FDA nod on its coronavirus test

Modern Healthcare
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    AFP/Getty Images
    (FILES)Jeff Bezos, CEO of Amazon, duringa press conference in this September 06, 2012 file photo in Santa Monica, California. The e-commerce giant announced July 29, 2013 that it plans to hire over 5,000 new workers in the US to work in its fulfillment centers, handling and processing customer orders. The company is also adding 2,000 jobs in customer service in several locations in the US. The announcement comes ahead of President Barack Obamas visit Tuesday to Amazons Chattanooga, Tennessee fulfillment center, where he is expected to outline policy proposals to spur the creation of middle-class jobs. AFP PHOTO/JOE KLAMAR (Photo credit should read JOE KLAMAR/AFP/Getty Images)

    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.

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