Companies racing to get approval for new coronavirus tests

Posted at 5:01 PM, Mar 23, 2020

ABBOTT PARK, Ill. – As the coronavirus continues to spread and the need for more testing grows with it, labs across the U.S. are racing to get approval for their tests for COVID-19.

The company Abbott is one of them.

“Abbott was able to get an emergency use authorization for a new test, molecular test for the SARS-coronavirus-2,” said John Hackett, Jr., the Divisional Vice President of Applied Research and Technology at Abbott.

Researchers inside their Illinois lab created a test that can be used with the company’s testing system, called “m2000 RealTime.”

That’s key because the company says that system is already widely available in hospitals and testing labs around the country.

“These are in hospitals and academic centers and this is where the test volume is,” Hackett said.

The speed in regulatory approval from the FDA for the test was unprecedented. The company said that, normally, it can take several years to get a test approved; this one happened in a matter of weeks. Their testing system can run through 470 patient tests per day.

“This is a massive impact when you think about trying to get results back to the physicians,” Hackett said. “This is actionable information - either a person's infected or they're not.”

About 150,000 tests are now on their way to hospitals and labs in 18 states – including New York, California and Washington – some of the hardest hit by COVID-19. The company plans to be producing a million tests a week by the end of this month.

Other companies, including those in California and Texas, have similar authorizations from the FDA and are hoping to provide more tests.

“The key thing here is to get to a point where we can change the trajectory, reduce the trajectory, reduce the number of new infections that are occurring,” Hackett said.

It’s a change they hope might put a dent in the coronavirus pandemic.