At-Home COVID-19 Test Kit; Amazon subsidiary gains US FDA approval

By Ashika Rajan, Trainee Reporter
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The American eCommerce giant Amazon has obtained the US Food and Drug Administration (FDA) approval for a COVID-19 test developed by its subsidiary STS Lab Holdco, which it intends to use for its onsite coronavirus testing programs.

A nasal self-swab is used in the procedure, which can be done under the supervision of a health care provider or as part of an at-home kit in which the patient collects their sample and mails it to a centralized lab.

According to the FDA’s approval “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.”

Amazon’s employee-screening program is also defined in the authorization. Every 14 days, some Amazon workers will be automatically given testing appointments. The tests are voluntary. The authorization said that “Amazon has partnered with a third-party healthcare provider who will issue the necessary prescriptions and individual test orders.”

Mr. Cem Sibay Vice President of Amazon Labs is the recipient of the authorization letter. Amazon hired Mr. Sibay to create its COVID-19 testing lab last summer. The company reported in October that it had the infrastructure in place to conduct tens of thousands of tests for employees every day. The latest test is a tweak of a Chinese BGI Genomics COVID-19 test that Amazon allegedly used at the end of August.

In 2020, the company started using the modified version that would become the Amazon test. According to the authorization, it ran over 560,000 samples between late September and early December 2020. In January, Amazon began selling COVID-19 testing kits made by DxTerity, a genomics company for $110.

The company is continuing to grow into healthcare, announcing last week that it will begin selling its in-house telehealth and at-home health care program to other companies. Amazon has previously shown an interest in medical testing. In 2018, the company was in talks to acquire Confer Health, a diagnostics company.

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