UPDATE March 30, 7:18 AM EDT: FDA approves the 'game-changer' test
The Food and Drug Administration gave "Emergency Use Authorization" to a novel five-minute point-of-care coronavirus test deemed a "game-changer" by experts, according to a LinkedIn blog post. Abbott Labs should make the tests available to urgent care clinics next week, according to the blog, with plans to increase manufacturing to deliver 50,000 tests per day.
50,000 tests a day
John Frels, vice president of research and development at Abbott Diagnostics, told Bloomberg that the firm plans to provide 50,000 tests a day starting April 1. The molecular test takes as little as five minutes, while a more thorough search to definitively rule out an infection can take up to 13 minutes, he said.
“This is really going to provide a tremendous opportunity for front-line caregivers, those having to diagnose a lot of infections, to close the gap with our testing,” Frels said. “A clinic will be able to turn that result around quickly, while the patient is waiting.”
The new test builds on Abbott’s ID Now platform, a common point-of-care test widely used to detect influenza, strep throat, and respiratory syncytial virus.
The test consists of first taking a swab from the nose or the back of the throat. The swab is then mixed with a chemical solution and inserted into an ID Now system. This system then identifies sequences of the coronavirus genome.
The ID Now system is a small box weighing less than seven pounds, which not only makes it conveniently portable but also well-suited for use anywhere and at any time. However, Abbott is working with the government to make sure the first machines go to where they are most needed, such as emergency rooms.
This is not the first Abbott system to make it to urgent care facilities. Last week, Abbott’s m2000 RealTime system received U.S. Food and Drug Administration approval. Between the two systems, Abbott has ambitious plans to provide at least 5 million tests a month.
Editor's Note: This article has been updated to include recent developments regarding federal mandates required before production of the new test can go forward. The FDA's authorization for Abbott Labs to move forward was added.