Amazon gets FDA authorization for at-home Covid-19 test

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An Amazon worker inside a warehouse during coronavirus pandemic

Amazon has received authorization 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 workforce as part of its Covid-19 preparedness and response program, according to a separate FDA document. Depending on their work schedule, employees may be scheduled for an on-site test or they’ll be given a collection kit to administer the test at home, the document states.

It’s unclear if Amazon intends to make the test available beyond its workforce or offer it commercially via its online marketplace. Representatives from Amazon didn’t 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 tapped to steer Amazon’s efforts to build an internal Covid-19 testing lab.

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

Amazon has long eyed medical diagnostics as an area of future expansion. In 2018, it looked at buying a start-up developing at-home health tests and it operated a team dedicated to diagnostics within its “Grand Challenge” moonshots group.

The FDA authorization comes as Amazon continues to expand its testing program for warehouse and delivery employees. In February, Amazon said its Kentucky lab had processed more than 1 million Covid-19 tests for front-line employees from more than 700 testing sites.

Amazon said it has started to automatically assign regular testing appointments for some workers at its facilities, typically every two weeks, although the assigned appointments are voluntary. Previously, employees could only sign up to get tested via an internal system.

The assigned appointments fall in line with Amazon’s previously stated goal of testing the bulk of its front-line workforce every two weeks. Earlier this week, Amazon said it would begin setting up on-site vaccination clinics at facilities in Missouri, Nevada and Kansas.

Last October, Amazon disclosed that nearly 20,000 front-line employees contracted Covid-19 between March 1 and Sept. 19. The disclosure came after labor groups, politicians and Amazon employees repeatedly pressed the company to disclose how many of its workers were infected by Covid-19, among other coronavirus safety concerns.

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