Amazon gets FDA approval for Covid-19 home testing

An Amazon employee in a warehouse during a coronavirus pandemic

Amazon has obtained approval from the Food and Drug Administration for a Covid-19 test that it hopes to use to bolster its employee screening program.

The test is being developed by Amazon subsidiary STS Lab Holdco, according to an FDA filing. The test is done via a nasal swab that individuals administer themselves, either under the supervision of a health care professional or at home.

Amazon plans to use the test among its staff as part of its Covid-19 prep and response program, according to a separate FDA document. Depending on their work schedule, employees may be scheduled for an on-site test or provided with a collection kit to administer the test at home, the document said.

It’s unclear whether Amazon plans to make the test available outside of its workforce or offer it commercially through its online marketplace. Amazon representatives did not immediately respond to a request for comment.

The FDA letter of authorization is addressed to Cem Sibay, vice president of Amazon Labs, who was previously a top executive of Amazon’s Prime unit. Business Insider reported last July that Sibay was called upon to direct Amazon’s efforts to build an internal Covid-19 testing lab.

CNBC reported in June that Amazon has built a dedicated team to develop its coronavirus testing capacity, appointing research scientists, program managers, procurement specialists and software engineers to support the effort. The company also launched standalone diagnostic labs in Sunnyvale, California, and Hebron, Kentucky.

Amazon has long watched medical diagnostics as an area of ​​future expansion. In 2018, the company looked to purchase a start-up developing in-home health testing and run a team dedicated to diagnostics within its “Grand Challenge” moonshots group.

FDA clearance comes as Amazon continues to expand its warehouse and delivery worker testing program. In February, Amazon said its Kentucky lab had processed more than 1 million Covid-19 tests for frontline workers from more than 700 test sites.

Amazon said it has begun to automatically assign regular test appointments for some employees in its facilities, usually every two weeks, although the assigned appointments are voluntary. Previously, employees could only register to be tested via an internal system.

The assigned appointments are in line with Amazon’s previously stated goal of testing most of the frontline staff every two weeks. Earlier this week, Amazon said it would begin setting up on-site vaccination clinics in facilities in Missouri, Nevada and Kansas.

Last October, Amazon announced that between March 1 and September 19, nearly 20,000 frontline workers had signed a contract with Covid-19. -19, among other coronavirus safety concerns.

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