Amazon receives FDA approval for the Covid-19 take a look at at dwelling
An Amazon employee in a warehouse during a coronavirus pandemic
Amazon has received approval from the Food and Drug Administration for a Covid-19 test designed to strengthen its employee screening program.
According to an FDA notification, the test is being developed by Amazon subsidiary STS Lab Holdco. The test is done through a nasal swab that individuals give themselves either under the supervision of a healthcare professional or at home.
According to a separate FDA document, Amazon plans to use the test as part of its Covid-19 readiness and response program among its employees. Depending on their work schedule, employees can be scheduled for an on-site test, or they can be given a collection kit to take 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 from Amazon did not immediately respond to a request for comment.
The FDA approval letter is addressed to Cem Sibay, vice president of Amazon Labs, who was previously an executive with the Amazon Prime unit. Business Insider reported last July that Sibay was being urged to steer Amazon’s efforts to build an in-house Covid-19 test lab.
CNBC reported in June that Amazon has built a dedicated coronavirus testing capacity development team that is using research scientists, program managers, procurement specialists, and software engineers to support the effort. The company also has separate diagnostic laboratories in Sunnyvale, California and Hebron, Kentucky.
Amazon has long kept an eye on medical diagnostics as an area of future expansion. In 2018, the company wanted to buy a start-up developing home health tests and had a team dedicated to diagnostics within its “Grand Challenge” moon shot group.
FDA approval comes as Amazon continues to expand its testing program for warehouse and delivery workers. In February, Amazon announced that its Kentucky laboratory had processed more than 1 million Covid-19 tests for frontline workers from more than 700 test sites.
Amazon announced that it has started automatically assigning regular test appointments to some employees in its facilities, usually every two weeks, even though the assigned appointments are voluntary. Previously, employees could only log in to be tested using an internal system.
The assigned appointments are in line with Amazon’s previously stated goal of testing the majority of its front-line workforce every two weeks. Earlier this week, Amazon announced it would begin setting up on-site vaccination clinics in facilities in Missouri, Nevada and Kansas.
Last October, Amazon announced that nearly 20,000 frontline workers signed Covid-19 between March 1 and September 19. The announcement came after working groups, politicians and employees of Amazon repeatedly asked the company to disclose how many of its employees were infected by Covid -19, including security concerns regarding coronaviruses.