Millions of COVID-19 tests to be made in suburban Chicago as Abbott, FDA worked at breakneck speed to address crisis

Millions of sorely needed coronavirus tests are going to be produced in a lab and manufacturing facility in northwest suburban Chicago, the result of breakneck work by scientists at Abbott and the decision of the Food and Drug Administration to cut red tape during this pandemic to approve new products.

This is the story of how it happened.

Seeing the coronavirus pandemic spread around the globe “made us really spring into action,” said Dr. John Hackett, Abbott’s divisional vice president of Applied Research and Technology for the company’s diagnostics business.

Developing the test and getting it to market, said Hackett, was a “great example of what’s possible when people will come together in moments of great need, and this certainly was one.”

Figuring out how to target the virus in the test is “a process that under a normal circumstance takes years. And this is an effort that really was in a time frame of weeks. And it was a 24/7 effort,” Hackett said.

With an explosion of cases, there is a growing demand for tests to diagnose COVID-19 in Chicago, the rest of Illinois and throughout the U.S.

Before you even take a test, however, you need other things that have been in short supply, in some places across the country: the long-tipped swabs used to collect material from up your nose or down your throat and certain chemicals to mix with the specimens.

People are using the word “test” in talking about the coronavirus pandemic, as if there were only one diagnostic test. There are multiple tests for COVID-19.

The coronavirus test devised by Abbott — the global health care company headquartered near the city of North Chicago in Lake County — and its manufacture in a northwest suburb is one piece of the urgently needed solution. I agreed not to name the suburb because of security concerns.

Abbott has decades of experience in dealing with infectious diseases; 25 years ago the company developed the first HIV test.

Hackett said the company pulled together a squad of “scientists from our infectious disease corps; from transfusion medicine, as well as molecular diagnostics, everybody pulling together, doing their part and then moving to manufacturing because you could have a test, but if you can’t manufacture it, it’s not going to be available to the public.”

This is where the FDA lifting the regulatory roadblocks comes into play. Earlier this month the FDA, addressing the crisis, gave emergency approval for COVID-19 diagnostic tests to Abbott and other companies.

In a March 18 letter to Abbott, Denise Hinton, the FDA’s chief scientist said, “I am authorizing the emergency use of your product. ... Based on the totality of scientific evidence available to FDA, it is reasonable to believe that your product may be effective in diagnosing COVID-19, and that the known and potential benefits of your product when used for diagnosing COVID-19, outweigh the known and potential risks of your product; and…there is no adequate, approved, and available alternative to the emergency use of your product.”

The time frame for Abbott was also sped up because the genetic sequence of the virus — think of it as sort of a code scientists needed — became publicly available.

There is no exact analogy, but let me take a stab in explaining where the swabs go to be diagnosed.

If the Abbott COVID-19 test is the software, the hardware is the mechanical apparatus containing sophisticated biomedical equipment to automatically analyze the nucleic acid from the throat and nasal swabs. Abbott’s is called the m2000 RealTime system.

There are about 175 of the large m2000 systems in U.S. hospitals and academic medical center laboratories, already in use to diagnose infectious diseases such as HIV and hepatitis. There are a handful of these devices in Illinois; an exact number was not available. Each one can run tests for 470 patients in 24 hours.

So far, Abbott shipped boxes containing more than 150,000 tests to 18 states, including Illinois, California, New York, Massachusetts and Washington.

The suburban manufacturing facility has several hundred people working around the clock -with the range of jobs filled from high school diploma holders to highly trained scientists with Ph.D.s in microbiology, chemistry and molecular biology.

The initial aim is to ramp up making one million COVID-19 tests per week for the m2000.

There’s more innovation in the pipeline. Abbott is working on COVID-19 tests that can be diagnosed in a medical office.