Amazon Gets Green Light from FDA to Sell COVID-19 Tests Directly to Consumers

Amazon Gets Green Light from FDA to Sell COVID-19 Tests Directly to Consumers

With its burgeoning list of Prime Day deals, Amazon has now received emergency use authorization from the US Food and Drug Administration (FDA) to add its COVID-19 test to its Prime offerings. Yes, that’s right, Amazon has developed its own COVID-19 test that consumers can now add to their shopping carts.

Amazon’s COVID-19 test is a real-time (RT)-PCR-based test developed by STS Lab Holdco, a subsidiary of Amazon.com Services LLC. The test kit is authorized to be used by individuals 18 years or older and does not require a prescription, nor proof of COVID-19 symptoms or recent contact with the COVID-19-causing coronavirus.

The test is indicated for use as a direct-to-consumer (DTC) product for testing anterior nasal swab specimens self-collected at home using the Amazon COVID-19 test collection kit DTC.

Amazon’s contributions to COVID-19 pandemic efforts began early this year as the online retail giant wrote a letter to US President Biden offering operational, IT and communications support for COVID-19 vaccine distribution.

Some might see this as an effort on Amazon’s part to combat the harsh criticism it has received since the beginning of the pandemic for failing to provide safe workplace conditions and unpaid sick leave to its employees.

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Testing is limited to laboratories designated by STS Lab Holdco to be certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263, and meet the requirements to perform high-complexity tests.

The FDA authorization also allows for pooled sample testing with up to five individual nasal swab specimens allowable per sample pool. The individual samples have to be collected in individual vials.

The Amazon COVID-19 test collection DTC kit includes a nylon swab, a collection tube, a plastic biohazard bag with absorbent pad and a return box with shipping label.

Test results from specimens collected with the Amazon COVID-19 test collection kit receive email and SMS text message notifications when their results are available online at amazondx.com. The DTC home collection system is intended to help users get information on their COVID-19 infection status so it can be determined whether self-isolation or quarantine is necessary, and to assist with other health care decisions after consultation with a health care provider.

Amazon’s foray into COVID-19 testing stems from laboratories it set up in Kentucky and in Greater Manchester to process COVID-19 PCR tests for employees.

STS Lab Holdco’s employee testing initiative received an EUA earlier this year, allowing use of its test for the regular screening for its employees. This includes assigning biweekly testing appointments to workers in its offices, warehouses and fulfillment centers who participated in the initiative. The employee-centered EUA also allowed for pooled testing of up to five nasal swab samples.

According to STAT News, Amazon is now operating several other laboratories that are authorized to process COVID-19 test results in at least seven states, including California, Texas and Florida.

Amazon’s Growing Health Portfolio

Amazon’s recent COVID-19 test offering is only a glimpse into its plans to go full-fledged into the health care sector. About two weeks ago, the retailer announced the national expansion of Amazon Care, a virtual-first health care platform that it has developed. In December 2020, it also created and trademarked Care Medical; Amazon had partnered with a Washington-based medical provider by the same name in 2018 to contract delivery of health care services.

Amazon’s rapidly expanding health portfolio so far includes in-person and virtual health care visits, health wearables and its COVID-19 pandemic response that even includes backing COVID-19 research, as the company has been pledging money to clinical trials evaluating convalescent plasma treatments.

On the health wearables side, the company launched a wristband called Halo last year that can track health indicators including heart rate and body fat.

The recent authorization of its COVID-19 test kit may help Amazon strengthen its positioning with respect to its ambitious health care ventures.