Abbott scores EUA for at-home COVID-19 antigen testing kit

Patients are virtually guided through the steps of sample collection and testing.
By Laura Lovett
02:02 pm
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Abbott landed an emergency use authorization (EUA) for a new at-home coronavirus antigen test where users can perform the test on themselves via digital guidance and get results in 20 minutes. The test, priced at $25, is prescription based. 

This isn't the first EUA for the testing product, known as BinaxNOW. However, the tool's first authorization designated that medical personnel conduct the sample collection. 

The new feature is born out of a collaboration between Abbott and digital health company eMed, which can help virtually deliver instructions and guidance to patients about how to self-administer the test.

Once a patient has a prescription for the tool, they are able to download Abbott's NAVICA app and access the eMed service to access a virtually guided online service. Users can get the testing kit delivered to their house.

According to Abbott, users will be able to access test results in 20 minutes via the NAVICA app, and can get QR for proof of test. Users can tap into eMed to get additional testing information. The test kit includes a test card and nasal swab. Once the sample is collected, the swab is put on the test card for evaluation, according to the original BinaxNOW announcement. 

The companies are planning to roll out the new service at the start of 2021 and administer 120 million tests by the end of the year.

WHY IT MATTERS 

Today over 70 million coronavirus cases and nearly 1.6 million deaths have been reported associated with the virus, according to the World Health Organization. Abbott is pitching this as a way for people to test themselves without leaving home and spreading the virus.

"As the pandemic has evolved, the need for rapid testing has only grown. Unfortunately, we're still hearing that many people can't access testing as quickly as they need it," Robert B. Ford, Abbott's president and chief executive officer, said in a statement.

"That's why Abbott is bringing our rapid BinaxNOW test and NAVICA platform into homes through this partnership with eMed, which allows us to maintain the integrity of the testing process, get even closer to people who need testing and help provide the confidence we need to help get back to living with a bit more normalcy."

THE LARGER TREND 

Home sample collection is growing in popularity as more companies seek EUAs. In November, the FDA granted the first EUA to a COVID-19 molecular diagnostic test that can provide patients with a result within 30 minutes in their home. 

The bulk of the "home testing" items have been sample collection kits, where patients send their sample to a lab and wait for results. Initial efforts to provide home sampling led to some confusion among testing startups, especially early in the pandemic. The agency has authorized a total of 288 tests (233 molecular, 58 antibody and seven antigen) as of Nov. 17.

The first to receive an EUA designation for home sampling was LabCorp's home collection RT-PCR test, which received an EUA in April.

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