Amazon received authorization from the Food and Drug Administration for a COVID-19 test done by its subsidiary STS Lab Holdco, and plans to use it for its on-site coronavirus testing programs.
The test is done with a nasal self-smear that can be done under the supervision of a healthcare professional or as part of a home kit, where the patient collects his own sample and sends it to a centralized laboratory.
“Amazon plans to use Amazon’s real-time RT-PCR Test for SARS-CoV-2 (Amazon Test) as part of the company’s overall coronavirus 2019 preparedness and response program (“ COVID-19 ”) , ”FDA authorization reads.
The authorization also describes Amazon’s employee screening program. Some Amazon employees will receive test appointments automatically every 14 days. The tests are voluntary. “Amazon has partnered with a third-party healthcare provider that will issue the necessary prescriptions and individual test orders,” said the authorization.
The letter of authorization is addressed to Cem Sibay, vice president of Amazon Labs. Last summer, Amazon hired Sibay to build its internal 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 every day.
The new test is a modification of another COVID-19 test done by BGI Genomics, which the authorization states that Amazon used in late August. The company started using the modified version that would become Amazon’s test on August 28, 2020. Between late September and early December 2020, more than 560,000 samples were processed, according to the authorization.
Amazon started selling home COVID-19 test kits made by genomics company DxTerity in January. This test sells for $ 110. The company continues to expand in health: last week, it announced that it would start offering its internal telehealth and home health program to other companies. Amazon has also expressed an interest in medical testing before. In 2018, the company was in negotiations to buy the diagnostic company Confer Health.