FDA approves coronavirus test that delivers results in five minutes

A medical device company just announced that it has made an important breakthrough when it comes to testing for the coronavirus. Abbott Laboratories is an Illinois-based medical device firm, and on Friday, it revealed new technology for detecting the disease.

The FDA issued emergency authorization for the test, which could prove to be a game-changer in the US as the nation struggles to furnish enough tests to control the outbreak.

Catching up

“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.

“Its unique isothermal nucleic acid amplification technology provides molecular results in just minutes, allowing clinicians to make evidence-based clinical decisions during a patient visit.”

The system “is already the most widely available molecular point-of-care testing platform in the U.S. today,” and is “the leading molecular point-of-care platform for Influenza A & B, Strep A and RSV testing in the U.S.”

Abbott’s system is said to be capable of producing “positive results in as little as five minutes and negative results in 13 minutes.”

“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,” Abbott’s president and chief operating officer Robert B. Ford added.

“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.”

“Game changer”

After receiving FDA approval for the new technology, Abbott says that it “expects to produce about 5 million tests per month.”

That news brought words of celebration from former FDA commissioner Scott Gottlieb, MD, who praised the company along with current officials in the Trump FDA.

“This is GAME CHANGER,” Gottlieb tweeted on Friday evening. “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,” he concluded.

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