Amazon Gets FDA Approval for COVID-19 Test Kit at Home

Amazon has received permission from the Food and Drug Administration for a COVID-19 test made by its STS Lab subsidiary Holdco and plans to use it for its on-site coronavirus testing programs.

The test is performed using a self-administered nasal swab, which can be done either under the supervision of a healthcare provider or as part of an at-home kit, where the patient takes their own sample and sends it to a centralized laboratory.

"Amazon plans to use the Amazon real-time RT-PCR test to detect SARS-CoV-2 (Amazon Test) as part of the company's general coronavirus disease 2019 ("COVID-19") readiness and response program," the FDA authorization states.

Authorization also describes the Amazon employee verification program. Some Amazon employees will be automatically given testing assignments approximately every 14 days. The tests are voluntary. "Amazon is partnering with a third-party healthcare provider that will issue the necessary prescriptions and customized test orders," the authorization says.

The permission letter is addressed to Jem Sibay, vice president of Amazon Labs. Last summer, Amazon used Sibay to create its own COVID-19 test lab, according to Business Insider. In October, the company said it had the infrastructure to run tens of thousands of tests for employees every day.

The new test is a modification of another COVID-19 test made by BGI Genomics, which Amazon said it used in late August. The company started using a modified version, which will become an Amazon test on August 28, 2020. Between late September and early December 2020, it ran more than 560000 samples, according to the resolution.

Amazon began selling at-home COVID-19 testing kits made by genomics company DxTerity in January. This test sells for $ 110. The company continues to expand into healthcare: last week, it announced that it would begin offering its own telemedicine and in-home healthcare programs to other companies. Amazon has also expressed interest in medical testing before. In 2018, the company is in talks to buy the diagnostic company Confer Health.

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