Amazon Gets FDA Clearance for Covid-19 Home Testing

An Amazon worker inside a warehouse during the coronavirus pandemic

Amazon received clearance 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 document. The test is done through a nasal swab that people administer themselves, either under the supervision of a healthcare 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 given a collection kit to administer the test at home, the document says.

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

The FDA clearance letter is addressed to Cem Sibay, vice president of Amazon Labs, who was previously a senior executive in Amazon’s Prime unit. Business Insider reported last July that Sibay was chosen to lead Amazon’s efforts to build an internal Covid-19 testing lab.

CNBC reported in June that Amazon created 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 independent diagnostic laboratories in Sunnyvale, California, and Hebron, Kentucky.

Amazon has long viewed medical diagnostics as an area for future expansion. In 2018, he sought to buy a startup that would develop home health tests and operated a dedicated diagnostic team within his “Grand Challenge” moon shot group.

The FDA clearance 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 automatically assigning regular test appointments for some workers at its facilities, usually every two weeks, although the assigned appointments are voluntary. Previously, employees could only register for testing through an internal system.

The assigned appointments coincide with Amazon’s previously stated goal of testing most of its frontline 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 revealed that nearly 20,000 front-line employees contracted Covid-19 between March 1 and September 19. The disclosure came after Amazon labor groups, politicians and employees repeatedly pressured the company to reveal how many of its workers were infected by Covid. -19, among other coronavirus safety concerns.


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