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Amazon selling FDA-approved at-home coronavirus tests

The kits were the first at-home saliva test to receive Emergency Use Authorization by the FDA.

WASHINGTON — Amazon and DxTerity Diagnostics announced a partnership last month to sell at-home coronavirus tests online.

The self-administered, non-invasive saliva kits were given the Food and Drug Administration's emergency use authorization at the beginning of December.

The tests from the Los Angeles-based company are currently available in single packs that cost $110 and in a 10-pack for $1,000 on Amazon. DxTerity said the price includes pre-paid overnight return shipment and testing in the company’s CLIA licensed and accredited laboratory.

The tests are the first at-home saliva test to receive Emergency Use Authorization by the FDA for symptomatic and asymptomatic testing. DxTerity said its test can detect the presence of viral genetic material, but it cannot confirm immunity or detect antibodies. 

“We have demonstrated the reliability and quality of our COVID-19 testing solution with big business and now we want to expand access to customers at home and small businesses,” said Bob Terbrueggen, Ph.D., Founder and CEO of DxTerity, in a statement.  “Amazon is the perfect partner for expanding access to millions of U.S. customers.”

DxTerity said that testing does not require supervised sample collection, and prescription authorization is included as part of test registration.

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For most people, the new coronavirus causes mild or moderate symptoms. For some, especially older adults and people with existing health problems, it can cause more severe illness, including pneumonia and death.

The United States has more than 21 million confirmed cases of COVID-19, according to data from Johns Hopkins University.

As of Wednesday, the U.S. had more than 357,000 deaths from the virus. Worldwide, there are more than 86 million confirmed cases with more than 1.8 million deaths.

Credit: Amazon
Image of DxTerity COVID-19 Saliva at-Home Collection Kit with Prepaid Express Return Shipping and Laboratory PCR Testing on Amazon.

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