FDA Approves Major Breakthrough In Fight Against Coronavirus

The Food and Drug Administration (FDA) issued an emergency authorization on Friday for a new coronavirus test that can deliver results in just 5 minutes and is so small that it can be used nearly anywhere.

Abbott Laboratories announced that their new test is the fastest test in the world, able to deliver “positive results in as little as five 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,” Abbott Laboratories said in a statement. “The ID NOW platform is small, lightweight (6.6 pounds) and portable (the size of a small toaster), and uses molecular technology, which is valued by clinicians and the scientific community for its high degree of accuracy. ID NOW is already the most widely available molecular point-of-care testing platform in the U.S. today. ”

“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.”

CNBC reported that the company plans to start providing 50,000 of the newly approved tests per day for officials to use.

“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,” the company added. “Between the two platforms, Abbott expects to produce about 5 million tests per month.”

Former FDA Commissioner Scott Gottlieb, MD, praised the announcement, hailing it as a game changer in the Trump administration’s fight against the coronavirus, which originated in China.

“This is GAME CHANGER,” Gottlieb wrote on Twitter. “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.”

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

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