Abbott has partnered with digital health provider eMed to provide telehealth-supported, at-home, prescription use of the cards, which run at $25 apiece. Similar in design to some pregnancy tests, the cards produce results within minutes over the Navica app — with no need to send samples to a lab.
Abbott and eMed plan to deliver and administer 30 million BinaxNow at-home tests in the first quarter of 2021, with an additional 90 million in Q2.
“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,” Abbott CEO Robert B. Ford said in a news release.
“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” Ford said.
In its own announcement of the EUA, FDA noted that antigen tests such as the BinaxNow are very specific for COVID-19, but are not as sensitive as molecular PCR tests. In other words, there is a higher chance of false negatives than with many molecular tests. And even though positive results are generally highly accurate, the tests are still subject to false-positive results especially in areas where there are fewer infections, according to FDA.
FDA commissioner Dr. Stephen Hahn said he thought at-home use of the Abbott testing cards will help provide greater testing flexibility and options for Americans as the novel coronavirus pandemic continues.
HHS Secretary Alex Azar said FDA’s authorization of the BinaxNOW card test for home use means that Americans should soon have access to tens of millions of COVID-19 tests that they can use at home. “HHS’s testing leadership have worked closely with companies like Abbott for months to accelerate the availability of these exciting new options, part of our commitment to bringing the best of the public and private sectors together to beat COVID-19.”
Just yesterday, FDA granted an EUA for the Ellume COVID-19 Home — the first fully at-home test for the novel coronavirus that the agency is authorizing for over-the-counter sales.