Amazon gets FDA approval for the Covid-19 test at home

An Amazon worker inside a warehouse during a coronavirus pandemic

Amazon has received permission from the Food and Drug Administration for a Covid-19 trial it hopes to use to bolster its worker screening program.

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

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

It is unclear whether Amazon intends to make the test available beyond its template 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 the chief executive of Amazon’s Prime unit. Business Insider reported last July that Sibay was taken advantage of to lead Amazon’s efforts to build an in-house Covid-19 testing lab.

CNBC reported in June that Amazon set up a team dedicated to developing coronavirus testing capability, assigning research scientists, program managers, procurement specialists and software engineers to support the effort. The company also launched stand-alone diagnostic labs in Sunnyvale, California, and Hebron, Kentucky.

Amazon has long viewed medical diagnosis as an area of ​​future expansion. In 2018, it examined the possibility of buying a start-up that would develop health tests at home and operated a team dedicated to diagnosis within its “Grand Challenge” moon launch group.

FDA approval 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 a million Covid-19 tests for front-line employees at more than 700 test sites.

Amazon said it has begun automatically assigning regular test appointments for some workers at its facilities, usually every two weeks, although assigned appointments are voluntary. Previously, employees could only sign up for testing using an internal system.

Assigned appointments fit Amazon’s previously stated goal of testing most of its front-line staff every two weeks. Earlier this week, Amazon said it would begin establishing on-site vaccination clinics at its Missouri, Nevada and Kansas facilities.

Last October, Amazon revealed that about 20,000 front-line employees hired Covid-19 between March 1 and September 19. -19, among other coronavirus security issues.

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