As COVID-19 cases surge across the U.S., there is growing demand for greater access to testing to rein in the pandemic. On Wednesday, the U.S. FDA granted an emergency use authorization (EUA) to Abbott Laboratories for at-home use of the company’s Binaxnow COVID-19 Ag Card Home Test. Abbott has teamed up with Miami-based telehealth provider Emed to distribute and administer the tests, with an expected 30 million in the first quarter of 2021.

The Binaxnow COVID-19 Ag Card rapid antigen test first received EUA approval in August for point-of-care use. The White House agreed to pay Abbott $750 million for 150 million units of the $5 test.

The at-home, virtually guided version will retail for $25 and requires a prescription. It is authorized for use with self-collected nasal swab samples from individuals 15 years and older who are suspected of having COVID-19 and are within the first seven days of symptom onset. It is also authorized for use with adult-collected samples from children ages four and older with suspicion of COVID-19 and seven or fewer days onset.

To get the Binaxnow home test, customers fill out a screening questionnaire via mobile app that is reviewed by an Emed’s representative. Once eligibility is determined, tests are shipped to users and Emed’s online service guides them through the self-collection process. Results are delivered in about 15 minutes.

“As the pandemic has evolved, the need for rapid testing has also grown,” said Robert Ford, Abbott’s president and CEO. “That’s why Abbott is bringing our rapid Binaxnow test and Navica [mobile app] platform into homes through this partnership with Emd, 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.”

Clinical evidence

To support its home-use submission, Abbott included multicenter data from 460 people ages six to over 60, which included analyses of patients by days since symptom onset and cycle threshold (Ct) count, the number of times a polymerase chain reaction (PCR) instrument must cycle through to amplify enough genetic material of the SARS-CoV-2 virus to be detectable.

Credit: Abbott Laboratories

The results showed an overall performance of 84.6% sensitivity and 98.5% specificity. For people within the seven-day post-symptom onset window with Ct counts of 33 or less, the group most likely to be infectious and spread COVID-19, the test’s sensitivity was 95.6%.

Since launching Binaxnow last summer, Abbott has scaled U.S. capacity to 50 million tests a month. With plans to distribute 30 million tests in the first quarter of 2021 and up to 90 million in the second quarter, that could push monthly capacity even higher, the Abbott Park, Ill.-based company said.

“The FDA continues to authorize COVID-19 tests that will give more Americans access to greater testing flexibility and options,” FDA Commissioner Stephen Hahn said in announcing the EUA. “The Binaxnow COVID-19 Ag Home Test will have a significant manufacturing footprint with the potential to support testing for millions of people.”

Wells Fargo analyst Larry Biegelsen said the company plans to sell the at-home tests via Emed to governments or large employers. “We caught up with management and the company said some portion of sales could be incremental but not a significant amount,” he wrote in a note.

He added that the cost of the tests could be slightly above the $5 average selling price for the Binaxnow COVID-19 Ag Card Test, given the slightly higher COGS of the home test, which includes an individual dropper.

Home test options growing

The nod for the Binaxnow home test comes one day after the agency authorized the first fully at-home COVID-19 home test that can be used without a prescription. On Tuesday, Ellume Ltd., of Brisbane, Australia, snagged an EUA for a rapid lateral-flow test for antigen detection that returns results at home in 20 minutes.

The authorization follow last month’s EUA for the Emeryville, Calif.-based Lucira Health’s all-in-one test kit, a prescription at-home test with a 30-minute turnaround. The Lucira test can be administered to those aged younger than 14 only by a health care professional. The FDA also granted an EUA to Laboratory Corporation of America, of Burlington, N.C., for its Pixel home collection kit for direct-to-consumer sale.

Abbott believes its test will compete well in the expanding COVID-19 home test market. The virtually guided service, a first for home tests, will help to ensure reliable results in a matter of minutes, and the $25 cost of the test and service is the lowest available for at-home testing, a spokesperson said.

Patrice Harris, Emed’s CEO, underscored the potential to increase testing among seniors, essential workers and communities of colors – three groups particularly hard hit by the pandemic.

“FDA’s authorization of Abbott’s Binaxnow test for home use is a breakthrough in the battle against COVID-19. I am proud to lead Emed’s partnership with Abbott to democratize access to frequent, affordable, at-home testing with results in 15 minutes.”