Amazon gets FDA authorization for an at-home COVID-19 test kit

Amazon received Food and Drug Administration authorization for a COVID-19 test made by its subsidiary STS Lab Holdco, and it plans to use it for its onsite coronavirus testing programs. The test is done using a nasal self swab that can be done either under the supervision of a health care provider or as part of an at-home kit where a patient takes their own sample and mails it to a centralized lab.

“Amazon plans to use the Amazon Real-Time RT-PCR Test for Detecting SARS-CoV-2 (Amazon Test) as part of the company’s overall Coronavirus Disease 2019 (“COVID-19”) preparedness and response program,” the FDA’s authorization reads.

The authorization also describes Amazon’s employee-screening program. Some Amazon employees will be automatically given testing appointments around every 14 days. The tests are voluntary. “Amazon has partnered with a third-party healthcare provider who will issue the necessary prescriptions and individual test orders,” the authorization said.

The authorization letter is addressed to Cem Sibay, the vice president of Amazon Labs. Last summer, Amazon tapped Sibay to build its in-house COVID-19 testing lab, Business Insider reported. In October, the company said it had the infrastructure to run tens of thousands of tests for employees each day.

The new test is a modification of another COVID-19 test made by BGI Genomics, which the authorization said Amazon used at the end of August. The company began using the modified version that would become the Amazon test on August 28th, 2020, and, according to the authorization, the company ran over 560,000 samples between late September and early December 2020.

Amazon started selling at-home COVID-19 testing kits made by genomics company DxTerity in January. That test sells for $110. The company continues to expand into health care: last week, it announced that it would start offering its in-house telehealth and at-home health care program to other companies. Amazon has also expressed interest in medical testing before. In 2018, the company was in talks to buy diagnostics company Confer Health.

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