Amazon Already Making a Mark on Direct-to-Consumer COVID-19 Test Market

Will Amazon transform diagnostic lab testing the way it did the retail industry? 
Probably not. But the tech giant with the proven capacity to reach into the home and change the shopping patterns of consumers has determined to make an impact on health care. And after establishing its Amazon Care telehealth service and launching its own Halo wellness-tracking smartwatch, Amazon has made significant inroads into the COVID-19 diagnostics market.

The Amazon COVID-19 Kit

During the pandemic, Amazon developed a proprietary COVID-19 RT PCR test to screen its own employees. In March, the FDA granted emergency use authorization (EUA) for the Amazon Real-Time RT-PCR Test for Detecting SARS-CoV-2 which detects the ORF1ab gene of the virus in anterior nasal swab specimens that can be self-collected using either the Amazon COVID-19 Collection Kit under the supervision of a healthcare provider or the Amazon COVID-19 Test Collection Kit unsupervised at home. On June 8, the FDA granted Amazon.com subsidiary STS Lab Holdco an EUA for a direct-to-consumer version of that test to be sold directly to consumers online.

Retailing at $39.99, the kit can be purchased without a prescription by any person age 18 or older, including for asymptomatic screening use. To purchase the kit, the customer must first register on Amazon’s AmazonDx.com diagnostic portal using an Amazon account. Registered users can also watch a video demonstrating how to use the kit, which comes with a nose swab, collection tube and a specimen bag. Delivery can be made in as little as one day in some areas. Once they collect the samples, users ship them to an STS Lab Holdco lab using the prepaid shipping label for processing, with results delivered directly via text or internet.

The Amazon test is also authorized for the qualitative detection of nucleic acid from SARS-CoV-2 in pooled samples containing up to five individual anterior nasal swab specimens per pool that are collected in individual vials containing transport medium.

The Amazon website also sells direct-to-consumers COVID-19 tests from other companies ranging from Quidel’s QuickVue rapid test for $24.95 to a 10-pack of EmpowerDX’s self-collected PCR test kits at a price of $890.

**************

This article originally appeared in G2 Intelligence, Laboratory Industry Report, July 2021