CONFRONTING COVID-19: How BioFire Mobilized to Develop a Comprehensive Testing Solution.

• Author: Stevenson, Wade

Early in the year, leaders at BioFire Diagnostics, a bioMerieux company, were monitoring the news coming out of China about a new and deadly respiratory virus. Executives were naturally concerned about the evolving humanitarian crisis in China and about the possible spread of the novel coronavirus into countries around the world. But the news about the virus was particularly relevant for BioFire--a Salt Lake City-based company that offers cutting-edge infectious disease testing instruments and reagent panels.

BioFire's diagnostic reagent panels test for a whole menu of pathogens associated with a particular disease syndrome, an approach called "syndromic testing." For instance, the BioFire[R] FilmArray[R] Respiratory 2 Panel can detect and identify 21 pathogens that cause respiratory illnesses like influenza, whooping cough, or the common cold--all with one test, and with results in about 45 minutes.

The syndromic approach maximizes the chances of finding out what's making a patient sick. Fast and accurate diagnostic results help physicians quickly provide appropriate treatment. BioFire currently offers diagnostic panels that tackle five infectious disease syndromes: respiratory infections, bloodstream infections, gastrointestinal infections, meningitis/encephalitis, and pneumonia.

"We knew in February that the novel coronavirus was spreading very fast and that we needed to help our customers identify it. Infectious disease diagnostics is what we do, and our respiratory products clearly needed to be updated to include the ability to detect this new emerging virus," said Stephanie Thatcher, vice president of molecular systems at BioFire.

That moment was a jumping-off point for an extraordinary, company-wide effort to develop the test, gain regulatory authorization, and meet unprecedented customer demand for BioFire's respiratory testing solutions--all while battling supply shortages, manufacturing capacity limits, and the necessity of keeping the workplace safe for BioFire's essential workers.

Focusing on the science

The first challenge for BioFire scientists was to develop a test that could accurately detect and identify the novel virus, called Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). This virus causes the disease we know as COVID-19.

To begin with, BioFire Diagnostics' teams supported their colleagues at BioFire Defense in its efforts to develop a targeted test for SARSCoV-2. "Then we looked at what it would take to...