- Abbott Laboratories said on Wednesday it won U.S. marketing authorization for a Covid-19 portable antigen test that can deliver results within 15 minutes and will sell for $5.
- Abbott expects to ship tens of millions of tests in September, ramping to 50 million tests a month from the beginning of October.
- Rapid antigen tests perform well while eliminating the waiting game, explains Abbott Laboratories CEO Robert B. Ford.
Robert B. Ford is president and chief executive officer at Abbott Laboratories. The Food and Drug Administration granted emergency use approval Wednesday to Abbott for its new coronavirus antigen test, which is the first Covid-19 test that delivers results in minutes on a testing card, similar to a pregnancy test.
We've been battling this pandemic for about six months in the U.S. It feels longer than that, I know. We're already compromising on a great deal—gathering, traveling, learning, working, and the peace of mind we've long taken for granted.
We all know there's more work to be done to keep up with the demand for fast and reliable Covid-19 testing. It's not for lack of trying. When the pandemic first hit, we – along with many of our peer companies – rallied to develop new tests for a previously unknown contagion in a matter of weeks. We've scaled up complex manufacturing equipment, processes, and facilities to produce millions of tests in months, something that normally would take a year or more.
Abbott Laboratories and our peers have developed several kinds of Covid-19 tests – some tests determine if a patient is infected while others track antibodies to indicate a past infection. Some produce results that are 98% to 99% accurate but take days to deliver results. Others offer performance in the mid-80s to mid-90s with results in about 15 minutes, making them valuable but harder to come by to date. In all, over 70 million tests have been administered since March in the U.S.
Even with this enormous undertaking, we're still seeing people waiting excessively long times for results due to overburdened labs and general confusion over what tests are available, where they're located, and when someone should get one. Results that take over a week to receive simply can't help us contain the spread of the virus.
We need a few game changers, and today, we're proud to announce one.
The BinaxNOW rapid antigen test and complementary mobile app called NAVICA are life-changing technologies that will attack the pandemic on several critical fronts – speed, simplicity, affordability, access, and accuracy. It will help us be more confident as we navigate work, school and life.
When you look at BinaxNOW, what you see is what you get. It's portable and convenient. It's an antigen test, the size of a credit card, with no equipment required and results delivered in 15 minutes, using proven lateral flow technology. It lets trained healthcare providers test a lot of people for active infections, a lot faster, on a single-use test.
The NAVICA app will be available at no charge and can be downloaded on Apple or Android devices. NAVICA works like a mobile boarding pass that can be used to board an airplane. Tests results obtained from a healthcare professional are stored as a digital pass that can be displayed as you enter certain places – like an office or school – and results are encrypted and made available only to the user and those that they share it with.
When we set out to design this test and app, we did it with accuracy, affordability and accessibility in mind. The old way of thinking is that health care products can't be all three at the same time, but we reject that premise. That's why we're selling the test to anyone who buys it from us for $5.
Rapid antigen tests perform well while eliminating the waiting game. While lab tests have the highest sensitivity, you have the tradeoff of not knowing results for several days and the risk of infecting others. Rapid tests deliver actionable results quickly so that infected patients can immediately begin self-quarantine. This test, along with others like it, is risk reduction on a societal scale.
BinaxNOW is also transformative in our ability to produce it in large volumes, which is what the country needs more than anything today. At Abbott, we've invested in two new U.S. facilities to manufacture this testing technology at scale. We'll be ramping up to produce tens-of-millions of tests in September, and we'll be producing 50 million tests a month in October and beyond. That means much greater access for those who need it.
Our intention is that BinaxNOW and NAVICA will help Americans recover a bit more confidence and normalcy in our everyday lives. No single test or digital platform can do it alone, but when used together, our tests empower people with the knowledge they need to make smart decisions.
I know that Americans are worried that absent a vaccine or effective therapeutic we face many more months of uncertainty. Our hope is that this test helps give us at least some of the peace of mind we need.