Birmingham’s BioGX producing COVID-19 test kits

Birmingham’s BioGX is manufacturing a large number of COVID-19 test kits in downtown Birmingham.

Birmingham’s BioGX is manufacturing a large number of COVID-19 test kits in downtown Birmingham.

Work happening inside Birmingham’s Innovation Depot might be the key to getting Americans back to work safely, as a large number of COVID-19 test kits are being manufactured right in the heart of downtown Birmingham.

That’s according to Michael Vickery, Ph.D., chief scientific officer and executive vice president at BioGX, a molecular diagnostics company founded in Birmingham in 2007. Molecular diagnostics applies molecular biology to medical testing to diagnose and monitor disease, detect risk and decide what treatments work best for individuals.

BioGX is manufacturing and distributing COVID-19 test kits with Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration.

Vickery believes that in order to get America back to work and to do it safely, there needs to be a public health framework to allow employers to test all employees before they return to work and provide ongoing testing for them once they have returned to work. He said BioGX has the capability to produce tests in very high quantities.

BioGX’s test uses the gold standard method of virus detection – a gene signature amplification method that allows for highly sensitive and specific results within one to two hours, depending upon what instrumentation is used to run it. The company produces a high-volume production version of the test that is presently being supplied in Europe through its European subsidiary, BioGX B.V., based in the Netherlands.

“We were one of the first to apply for and receive EUA approval,” Vickery said. “Our outstanding design and development capabilities, combined with our ability to perform high-volume manufacturing in our unique freeze-dried reagent formats that include all testing components in a single tube, give us a winning combination to help labs get critical testing into their hands in a short period of time. Our tests can be shipped anywhere in the world with no refrigeration.”

Manufactured in the heart of downtown Birmingham, already many hundreds of thousands of these tests have been shipped to hospitals and labs all over the world.

Vickery said BioGX’s staff of more than 70 in Birmingham started working on a test for the SARS-CoV-2 virus that causes COVID-19 as soon as it became evident that the virus would begin spreading outside of China. Within weeks, BioGX and its partner for distribution of this test, Becton, Dickinson and Co., applied for and were granted EUA for its test by the FDA. 

Ever since, the dedicated BioGX staff has been working around the clock, seven days a week to crank out as many test kits as possible every day, and will continue to do so as long as there’s a need.

To get back to normal, widespread testing will be absolutely critical, Vickery said, and BioGX is ready to be a nationwide and global contributor in the return to work effort.

“We believe that if we can screen everyone going back to work, we can reduce the spread of the virus and knock the infection rates down to get back to some level of normal life,” Vickery said. “Of course, the most important reason for testing is to stop the spread of the virus so we can save lives. Everyone at BioGX believes it is an honor to be able to step up and contribute in this way.”

BioGX’s most recent work with COVID-19 is critical, but the company’s reach expands beyond the pandemic, said Mark Brown, vice president of business retention and expansion at the Birmingham Business Alliance, who has worked closely with the company.

“The expertise and products that BioGX has in developing and manufacturing molecular reagents sets the baseline for clinical, pharma, food safety and water quality testing and analysis,” he said. “The team at BioGX has played a critical role in developing a COVID-19 test that is being used worldwide in support of the pandemic efforts. Having the capability to support mass testing is critical in getting people back to work safely. Hats off to the team at BioGX for being a difference maker.”