Abbott’s new ID NOW COVID-19 test, which earned emergency use authorization (EUA) from FDA last week, was highlighted during President Donald Trump’s COVID-19 taskforce press briefing on March 30. FDA Commissioner Stephen Hahn spoke about the rapid approval of Abbott’s point-of-care test for COVID-19.
“Normally these tests take months to develop,” Hahn noted during the briefing. “I was on the phone today with the Abbott CEO who told me this is normally a 9- to 12-month approach to developing a point-of-care test. They did this in collaboration with FDA and the U.S. government in just a few weeks.”
MD+DI checked in with Abbott and heard from Norman Moore, PhD, scientific affairs, infectious diseases, Abbott, who said that “while developing new molecular tests normally takes years, our expert teams of scientists worked around the clock to compress the timeframe down to weeks.”
The new COVID-19 test runs on Abbott’s portable molecular-testing ID NOW platform—the unit was displayed sitting on a table during the White House briefing. The platform was introduced in 2014 and is widely used for Influenza A and B, Strep A, and RSV testing in the United States. Such molecular testing detects the presence of a virus by identifying a small section of the virus’s genome, then amplifying that portion until there’s enough for detection, Abbott explained on its site. A positive result can be delivered in five minutes, and a negative one in 13 minutes, the company stated.
“The COVID-19 test uses the same approach as our POC influenza tests,” Moore told MD+DI. “The new ID NOW COVID-19 assays can be used on existing ID NOW equipment.”
The rapid ID NOW COVID-19 test is on a rapid path to market. “Our manufacturing teams are working to ramp up production to its highest levels,” Moore said. “We will deliver 50,000 tests a day beginning April 1st.”
The test is Abbott’s second to receive FDA’s EUA for COVID-19 virus detection. The first was Abbott’s RealTime SARS-CoV-2 EUA test for use on its molecular laboratory instrument, the m2000 RealTime System. Abbott expects to produce about 5 million tests for detecting the COVID-19 virus per month for the m2000 RealTime System and ID NOW platforms combined.
“The most innovative and safe products come from the private sector in partnership with government taking an all-hands-on-deck approach just like in this case,” Hahn said during the March 30 White House briefing. “Abbott and FDA worked together to make sure that we had a fast, reliable, and accurate test to market.”