Utah companies rally to fight the coronavirus: Local biotech companies released coronavirus tests in a manner of weeks illustrating a commitment to communities everywhere.

AuthorForeman, Kelsie

AFTER A NEW VIRUS, COVID-19 (SARS-CoV-2) was deemed a pandemic by the World Health Organization and then rapidly spread throughout the United States and other countries throughout the world, healthcare professionals and patients alike became vocal about the lack of testing kits available throughout the state and country.

In order to ensure that a greater percentage of the population would have accessibility to testing in the event that it was needed, the Food and Drug Administration announced a series of regulatory changes for laboratories and other diagnostic companies that gave already certified high-complexity laboratories (such as the ones found in hospitals or doctor's offices) the ability to use their own tests to diagnose COVID-19, instead of the pre-authorized and distributed tests from the CDC.

BIOFIRE DIAGNOSTIC CREATED CORONAVIRUS SCREENING TESTS IN ONLY TWO MONTHS

As a result, several Utah biotech companies stepped up to the plate, including Biofire Diagnostics, and it's sister company BioFire Defense, who created a specific biological test used to help healthcare providers throughout the country screen for the novel virus. Partnering with the Department of Defense on the development of the test, BioFire managed to create the test and have it certified for use in as little as two months, a light-speed feat just when patients across the world needed one the most.

"Part of that [shortened time frame] was because the FDA was amazing. They were so good to work with. My team was sending emails to the FDA in the middle of the night and they were getting responses within minutes. It was super impressive. And so I think that's why the development time was super-compressed," says Wade Stevenson, senior vice president of BioFire Diagnostics when discussing the timeline of the BioFire test. "The Department of Defense [also] provided us with some end-targets that supported the product that they wanted and they gave us some funds to help get there. The development work was done by BioFire Defense and then BioFire Diagnostics does most of the manufacturing."

The BioFire test wouldn't have become a reality without their hundreds of employees coming in to work on the front lines every day. "You can't do research and diagnostics from home," laughs Stevenson when asked how the company is handling the process while adhering to the new social distancing guidelines. "You also can't fit production lines into anyone's home. So we, as a company, had to...

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