Prime Day deal? Amazon lands FDA go-ahead to sell COVID-19 tests directly to consumers

A worker inside Amazon's in-house COVID-19 testing lab
Amazon previously received an emergency use authorization for its PCR test to be distributed to its employees at regular intervals, about every two weeks. That clearance initially required a prescription from a contracted healthcare provider. (Amazon)

Just in time for its annual online sale event, Amazon has gotten the green light from the FDA to begin hawking its own COVID-19 test directly to consumers—potentially setting up the most coveted Prime Day deal of all.

The FDA’s emergency use authorization allows the retail giant’s subsidiary STS Lab Holdco to sell its Amazon Real-Time RT-PCR test kits to anyone 18 years or older without requiring buyers to obtain a prescription or show proof of any COVID symptoms or recent contact with the virus.

The EUA also allows for pooled testing, in which up to five individual samples may be combined and tested at the same time, exponentially increasing the reach of Amazon’s lab resources.

After each nasal swab kit is sent to one of Amazon’s processing labs using the included prepaid shipping label, users will receive notifications via text message and email once their test results are ready. The results can then be accessed through an online portal located at AmazonDx.com, according to FDA documents, though that site is still currently being used only for Amazon’s employee testing efforts.

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STS Lab Holdco’s employee testing initiative received an EUA of its own earlier this year. In March, the FDA cleared the Amazon Real-Time RT-PCR kit for use in screening employees at regular intervals.

With that clearance, Amazon was given the go-ahead to automatically assign biweekly testing appointments to workers in its offices, warehouses and fulfillment centers who participated in the initiative. As with the DTC clearance, the employee-focused EUA allowed for pooled testing of up to five nasal swab samples at once.

The test kit was initially only approved for prescription use—with Amazon contracting a healthcare provider to sign off on a standing-order prescription—and could be administered either on one’s own at home or while being supervised virtually by a telehealth provider.

Through that program, as soon as an employee received a positive test result, they would receive a message urging them to either leave their job site immediately or stay home and prompting them to contact their healthcare provider.

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Both versions of the COVID test kit are the product of groundwork Amazon began laying in the earliest days of the pandemic. In March 2020, the company directed a group of its research scientists, software engineers and program managers to begin developing an in-house testing initiative.

Since then, Amazon has opened labs in Kentucky and the U.K., with a recent BBC report noting the U.K. lab had processed at least 900,000 test samples as of early June.

And while demand for COVID-19 tests is rapidly drying up, Amazon’s healthcare aspirations are only growing bigger. Sources close to the company have previously revealed that the same scientists who led the in-house testing efforts may be tapped to develop even more diagnostic offerings, including tests for respiratory illnesses and sexually transmitted infections as well as clinical genomic assays.

That growth would build on Amazon’s many other forays into healthcare. Last August, for example, it launched the Halo smartwatch. The wearable is designed to be worn around the clock and tracks not only a wearer’s daily physical activity and vital signs but also changes in their emotions and energy levels, thanks to machine-learning-powered voice analysis.

Additionally, this summer, echoing its COVID test’s evolution from an employee benefit to a nationwide moneymaker, the company will expand its Amazon Care telehealth service to employers across the U.S.

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Ultimately, all of these disparate projects could one day coalesce to form an end-to-end healthcare service.

“The Halo device can monitor the vitals of someone with a chronic disease, Alexa can then remind them that it’s time to make an appointment. They can do a virtual visit and also get a test kit in the mail for lab testing,” Michael Abrams, a managing partner at consulting firm Numerof & Associates, previously told Fierce Healthcare.

Abrams added, “They are taking steps that are synergistic. Amazon Care is synergistic with Amazon Pharmacy, and both of them would be synergistic with a diagnostics line of business as well.”