Amazon gets FDA authorization for Covid-19 home test

An Amazon worker inside a warehouse during the coronavirus pandemic

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

The test is being developed by Amazon’s subsidiary STS Lab Holdco, according to an FDA record. The test is done using a nasal swab that the individuals themselves administer, under the supervision of a health 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 can be scheduled for an on-site test or receive a collection kit to administer the test at home, the document states.

It is unclear whether Amazon intends to make the test available in addition to its workforce or offer it commercially through its online marketplace. Amazon representatives did not immediately respond to a request for comment.

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

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

Amazon has long seen medical diagnostics as an area of ​​future expansion. In 2018, she planned to buy a start-up developing health tests at home and operated a team dedicated to diagnostics within her group of “Big Challenge” moonshots.

FDA authorization comes at a time when Amazon continues to expand its testing program for deposit and delivery employees. In February, Amazon said its Kentucky laboratory processed more than 1 million Covid-19 tests for frontline employees at more than 700 test sites.

Amazon said it started automatically assigning regular test appointments to some workers on its premises, usually every two weeks, although the consultations are voluntary. Previously, employees could only apply to take the test through an internal system.

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

Last October, Amazon reported that nearly 20,000 front-line employees hired Covid-19 between March 1 and September 19. The disclosure came after labor groups, politicians and Amazon employees repeatedly pressured the company to reveal how many of its workers were infected by Covid -19, among other coronavirus security issues.

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