- Abbott is launching a quick-turnaround test for the novel coronavirus on the same portable, point-of-care systems it uses to test for more common illnesses like strep and flu, the company said late Friday after receiving emergency use authorization from FDA.
- The Chicago area based medtech giant touted both the speed and scale of the new test, its second OK'ed by the regulatory agency to detect COVID-19, reporting it can return positive results in as little as five minutes, and negative results in 13 minutes. The company claims its ID Now machines are "already the most widely available molecular point-of-care testing platform in the U.S. today."
- Combined with production of its slower test FDA greenlighted nine days earlier, Abbott said it expects to make about 5 million tests for COVID-19 per month.
Abbott's latest COVID-19 product isn't the first point-of-care test on the U.S. market; Danaher molecular diagnostics subsidiary Cepheid claimed that milestone with an EUA awarded March 20.
But the turnaround time and reach of Abbott's new test so far appears unparalleled in the U.S. Cepheid said there are about 5,000 of the systems that process its tests within 45 minutes in hospitals across the U.S.
Abbott did not specify the number of its portable ID Now machines (likened to a toaster-size, lightweight box) existing in the field, but said they're "already widely available in physicians' offices, urgent care clinics, and hospital emergency departments."
President Donald Trump highlighted the Abbott test during a briefing Sunday, saying it signals "a whole new ballgame" in U.S. testing of coronavirus. Former FDA Commissioner Scott Gottlieb, who's routinely called for wider scale testing, also heralded the development.
This is GAME CHANGER. Abbott to market, starting next week, a fast point-of-care #coronavirus test, delivering positive results in 5min and negative results in 13min. Will deliver 50K tests/day to start. Kudos to Abbott and FDA’s Jeff Shuren and team at CDRH who are in the fight.— Scott Gottlieb, MD (@ScottGottliebMD) March 28, 2020
Abbott did not share figures on the sensitivity or specificity of the test. A spokesperson said "performance was established by testing a limited number of contrived samples," and performance characteristics, including accuracy data, will continue to be collected in the field.
The medtech is slated to make its top leadership transition official this week. On Tuesday, longtime CEO Miles White is set to hand the reins to president and COO Robert Ford. In Abbott's statement Friday, Ford said the development from Abbott will enable testing "outside the traditional four walls of a hospital in outbreak hotspots."
A month has now passed since FDA issued an updated policy allowing for greater use of lab-developed tests and tests that have not yet received emergency use authorization. To date, FDA has disclosed EUAs for 20 novel coronavirus tests. Abbott is the first test maker to secure more than one EUA for the virus.
The agency has collaborated with more than 230 test developers interested in submitting requests for EUAs, according to an update Monday morning, and more than 110 labs have reportedly told FDA they've started using their own tests.
In the same update on diagnostic testing, FDA Commissioner Stephen Hahn appeared to acknowledge ways to improve testing ramp-up in future public health crises, in light of criticism of CDC and other federal health authorities' response to the novel coronavirus.
"In the future, making viral samples available earlier to commercial developers will be crucial to deploying tests quickly," Hahn said in a statement. "Moreover, CDC's test should be manufactured by a commercial entity with the requisite expertise."