Earlier this year, Abbott unveiled a cheap coronavirus diagnostic contained entirely on a paper booklet the size of a credit card, designed to deliver a reading within 15 minutes. Paired with its Navica smartphone app, the BinaxNOW antigen test aims to provide a “digital health pass” users can display as proof of a clear result.
Now, the FDA has authorized a new version of the test for use in the home with a physician’s prescription—marking the agency’s third home-based test this month.
Available for $25 plus shipping, Abbott’s test allows anyone aged 15 and up to swab their noses themselves and process the sample, while being guided through the steps virtually via a telehealth connection. Meanwhile, adults may use the swab on children as young as 4.
"As the pandemic has evolved, the need for rapid testing has only grown,” Abbott President and CEO Robert Ford said. “Unfortunately, we’re still hearing that many people can’t access testing as quickly as they need it."
In partnership with digital service provider eMed, the company expects to deliver 30 million BinaxNOW tests by the end of March plus an additional 90 million before the end of June. EMed will also report all test results to the relevant public health authorities.
While antigen tests are not as accurate as molecular, laboratory-based tests, the ability to cast a larger net to screen for COVID-19 and urge those with positive results to isolate themselves has wider benefits. People who test negative may need additional testing, especially if they continue to show symptoms.
Last month, the FDA authorized its first home-based molecular test kit, developed by Lucira Health, which can go from a swab to a result in about 30 minutes. And earlier this week, the agency greenlighted its first over-the-counter home test, made by Australian diagnostic company Ellume.
In addition, the FDA recently gave its blessing to LabCorp’s Pixel over-the-counter test kit, allowing people to mail their swab for analysis without a prescription.
"We know that a majority of people aren’t yet fully comfortable with testing themselves at home from recent consumer research, so the eMed service is designed to provide a confident and seamless experience," said Abbott’s senior VP of rapid diagnostics, Chris Scoggins.
"The simplicity and convenience of the at-home test and being able to display your results on the Navica app, coupled with vaccines and other protective measures, will give us all a shot at some semblance of normality and getting back to our lives."