Coronavirus Test Made By Abbott Labs Wins Emergency FDA Approval

NORTH CHICAGO, IL — Abbot Laboratories announced it has begun sending 150,000 newly approved tests for the new coronavirus to hospitals and medical centers across the country.

The North Chicago-based medical device maker issued a statement Wednesday saying it has received an emergency use authorization from the U.S. Food and Drug Administration for its new molecular test to identify SARS-CoV-2, the novel strain of coronavirus that causes COVID-19.

"A global challenge like coronavirus requires the commitment and cooperation of everyone who has the ability to help address it," chairman and chief executive officer Miles White said. "I'm proud of the Abbott team and what they've accomplished in such a short period of time, and I want to thank the Administration and the FDA for their partnership in making this happen."

Company officials aim to ramp up production to provide 1 million tests a week by the end of the month, according to a statement.

"Since the beginning of the coronavirus outbreak, it's been really important to do testing, because that's the important piece of the puzzle to get patients the care they need," said Mary Rodgers, a diagnostics senior scientist in Abbott's infectious disease research lab. "But also to protect our families and communities."

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The tests are designed for use in Abbott-made machines that can process up to 470 test in 24 hours. There are more than 175 such "m 2000" systems currently being used in hospitals and reference laboratories, and the company is coordinating with health systems and government authorities to deploy more systems where needed.

John Hackett, vice president of Abbott's applied research and technology diagnostics division, said the m 2000 devices were unique in their ability to rapidly process large numbers of test samples.

"This provides an opportunity to get reliable results in a relatively short period of time," Hackett said. "This is critical to containing the ongoing spread of this virus."

The news comes just over 35 years since Abbott developed the first test for HIV. According to the company's head of molecular diagnostics, Daman Kowalski, many of the same scientists who developed that test and the company's Zika virus tests worked "around the clock" on the new coronavirus tests.

Last week, California-based Roche Molecular Solutions received emergency FDA approval to begin distributing its new COVID-19 testing. The company, which plans to eventually produce about 400,000 test a week, is distributing the kits to more than 30 hospital and research labs. According to a statement, the company's "cobas 8800" systems can process up to 960 results in an eight-hour shift and provide results in about 3.5 hours.

In Illinois, 3,151 tests for the novel coronavirus had been completed as of Thursday afternoon, with 422 people testing positive. Four people have died.

But a lack of widely available COVID-19 tests has limited the number of patients who are able to get tested, even if they are showing signs of infection such as a fever, dry cough and shortness of breath.

"Just because they are symptomatic," Lake County Health Department Emergency Response Coordinator Patti Corn said, "will not mean that they have the ability to get tested, due to the restrictions right now on testing."