America's FDA Grants Emergency Approval for a 15-Minute Coronavirus Test

While many coronavirus tests provide results within hours or days, America’s Food and Drug Administration “has authorized the emergency use” of a new rapid coronavirus test from medical device manufacturer Abbott that could results in less than 15 minutes, reports NBC News:
The FDA told Abbott it authorized the test’s use after determining that “it is reasonable to believe that your product may be effective in diagnosing COVID-19,” based on the scientific evidence presented. The agency added that the “known and potential benefits” of the test outweigh potential risks, such as false positives or negatives. The technology being used for the new test is similar to the one found in rapid flu tests, according to the FDA’s authorization letter and Abbott.

The FDA also said Friday it has issued at least 19 other emergency use authorizations for diagnostic tests to detect COVID-19, and that it is working with more than 220 test developers who are expected to submit emergency-use authorization requests soon…

Abbott said it is ramping up production to deliver 50,000 tests to the U.S. health care system starting next week.

Read more of this story at Slashdot.



Source: Slashdot – America’s FDA Grants Emergency Approval for a 15-Minute Coronavirus Test

Leave a Reply