Abbott has scored yet another Emergency Use Authorization for rapid coronavirus testing – this one, named BinaxNOW COVID-19 Ag Card, come in the form of a card and can provide results in 15 minutes.
The other notable difference in this test is the price point. Abbott said it will sell the tests for $5 each.
Users will also be able to link their results to Abbott’s app dubbed NAVICA, which will provide users with what Abbott calls a “digital health pass” displaying negative results on the phone. The app is able to keep track of when a person has a test at their healthcare provider, the result of the test, and the date.
The idea is that an individual will be able to show their test results to different organizations, such as schools or work places, in order to get access.
The test, which is designated for use by healthcare professionals at approved point-of-care facilities, includes the test card, extraction reagent, nasal swabs, a positive control swab, a negative control swab, a product insert and a procedure card.
Abbott is planning to make a million tests a day, and produce 50 million by the beginning of October.
WHY IT MATTERS
Since the onset of the coronavirus pandemic, testing has been marred with setbacks and divisions. In the spring the U.S. had a shortage of coronavirus tests. In February the Secretary of HHS announced the public health crisis justified authorization of the emergency use of in vitro diagnostics for COVID-19 testing. Since this announcement, the agency has worked with hundreds of companies to assist them in earning EUAs.
However, the amount of oversight on these tests is evolving. On August 23 the U.S. Department of Health and Human Services released plans to limit FDA premarket review of laboratory-developed tests. This was met with pushback from those in the medical community, including former FDA Commissioner Dr. Scott Gottlieb.
“For the last 6 months, FDA’s device center worked effectively with labs to advance hundreds of tests for Covid. A new HHS policy that extricates FDA from this work – and goes further, by removing any FDA role over any lab developed test – could put this work at risk,” he wrote on Twitter.
As the debate around testing continues, the coronavirus continues to sweep across the U.S. The CDC reported 37,086 new cases yesterday. So far there have been over 5.7 million cases reported in the U.S.
THE LARGER TREND
Early on Abbott emerged as one of the leaders in the rapid coronavirus testing space. In March it rolled out its ID Now COVID-19 test, proposing that it could produce 50,000 tests a day.
However, in May the FDA released a statement outlining possible accuracy concerns with the Abbott ID Now Point-of-Care Tests. In particular, the agency was warning of possible false negative results.
But this wasn’t the only coronavirus test too face some hurdles. In mid-March the FDA posted an update to the policy saying that it would begin permitting certain COVID-19 tests that haven't yet received an EUA, as long as they were actively working towards a clearance.
This caused some confusion, and a slew of diagnostic-testing startups announced new services that would deliver at-home COVID-19 testing kits to consumers.
Shortly after the take-home-testing companies announced their plans, the FDA released an alert to consumers warning of "unauthorized fraudulent COVID-19 test kits" that specifically noted that "the FDA has not authorized any test that is available to purchase for testing yourself at home for COVID-19." Since then, a majority of the tests were rescinded.