An Abbott Molecular sign stands near the entrance one of its facilities in Des Plaines, Illinois, … [+]
Abbott Laboratories won U.S. Food and Drug Administration approval for its molecular test for the Coronavirus strain COVID-19, which the company says can deliver “positive results in as little as five minutes and negative results in 13 minutes.”
The FDA’s “emergency use authorization” awarded to Abbott’s ID NOW COVID-19 test is the latest in a growing number of agency approvals for more rapid molecular “point-of-care” diagnostic tests that can be used in temporary screening locations, doctor’s office labs and nursing homes to detect the Coronavirus strain COVID-19 within a half hour.
“With rapid testing on ID NOW, healthcare providers can perform molecular point-of-care testing outside the traditional four walls of a hospital in outbreak hotspots,” Abbott president and chief operating officer Robert Ford said.
In less than a week, the FDA has escalated approvals of rapid “point-of-care” diagnostics made by other companies including Mesa Biotech and Cepheid which are also ramping up production to meet unprecedented demand. In Abbott’s case, the company said it will be making ID NOW COVID-19 tests available next week with the ability to deliver 50,000 tests per day.
And that kind of production will be welcome to U.S. healthcare providers on the frontlines as well as a Trump White House and federal health agencies dogged by criticism for the lack of testing for Coronavirus. The U.S. is considered well behind other countries when it comes to the availability of testing generally even with more than 81,000 reported Coronavirus cases – the most reported from any country in the world as of Thursday.
Prior to FDA approval of the rapid tests, many of the Coronavirus tests recently approved earlier this month are used in large hospitals and academic medical centers.
Abbott, which won an FDA emergency use authorization earlier this month for its “m2000TM RealTime System” that is used by hospitals and academic medical centers to speed diagnostic capabilities, has an established history in the development of diagnostic tests, particularly for infectious diseases like the AIDS as the developer of the first HIV test.
Abbott’s ID NOW, which was first launched in 2014, is also a molecular point-of-care platform for Influenza A & B, Strep A and RSV testing in the U.S., the company said.
“The COVID-19 pandemic will be fought on multiple fronts, and a portable molecular test that offers results in minutes adds to the broad range of diagnostic solutions needed to combat this virus,” Ford said.