Global healthcare company Abbott (NYSE: ABT) has announced that the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for its molecular point-of-care test for the detection of novel coronavirus (COVID-19), delivering positive results in as little as 5 minutes and negative results in 13 minutes.
The test will run on the company’s ID NOW platform, providing rapid results in a wide range of healthcare settings such as physicians’ offices, urgent care clinics, and hospital emergency departments.
The ID NOW platform is small, lightweight (6.6 pounds) and portable (the size of a small toaster), and uses molecular technology. The company expects to ramp up manufacturing to deliver 50,000 tests per day.
At present, it takes from a few hours to a few days before the result of a test is made available. With Abbott testers, the healthcare providers will be able to conduct more tests to know the actual impact of coronavirus in a particular area.
“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,” said Robert B. Ford, president and chief operating officer, Abbott. “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.”
In our efforts to help facilitate more widely available testing along with more rapid testing, FDA issued an emergency use authorization (EUA) to Abbott Diagnostics Scarborough, Inc. for a point of care #COVID19 diagnostic for the ID NOW COVID-19 test. https://t.co/PjWkgj2R2Q pic.twitter.com/urcspWdC3i
— Dr. Stephen M. Hahn (@SteveFDA) March 28, 2020
Abbott will be making ID NOW COVID-19 tests available next week (starting March 30) to healthcare providers in urgent care settings in the U.S., where the majority of ID NOW instruments are in use today. The company is working with the Administration to deploy tests to areas where they can have the greatest impact.
— Abbott (@AbbottNews) March 27, 2020
The arrival of the Abbott ID NOW COVID-19 test comes a week after the company launched its Abbott m2000 RealTime SARS-CoV-2 EUA test, which runs on the m2000 RealTime System located in hospital and reference labs around the world. Between the two platforms, Abbott expects to produce about 5 million tests per month.
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