Utah company develops first fully FDA-authorized COVID-19 test

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A BYU life science student works with COVID-19 samples. A Utah lab called BioFire developed the first fully FDA-approved COVID-19 test. (Todd Jackson)

A biotech company from Utah has developed the first COVID-19 test to be fully authorized for use by the U.S. Food and Drug Administration.

The test, known as the BioFire Respiratory Panel 2.1, was granted full marketing authorization by the FDA on March 17. Other COVID-19 tests are being used under the FDA’s Emergency Use Authorization which will ultimately be lifted as the country nears the end of the pandemic.

“Today’s action is a great demonstration of the FDA’s work to protect the public health in emergency response situations and beyond,” said FDA acting commissioner Janet Woodcock in a statement. “While this is the first marketing authorization for a diagnostic test using a traditional premarket review process, we do not expect this to be the last.”

Salt Lake City-based BioFire‘s test offers simple usage and quick results using polymerase chain reaction (PCR) technology. PCR is a testing method that rapidly makes millions or billions of copies of a DNA sample so scientists can amplify a small sample and study it in close detail.

PCR is not unusual in COVID-19 testing technology. PCR tests are known for being more accurate than antigen tests because antigen tests are more likely to miss an active COVID-19 infection and produce false negative results.

“Outside studies have shown that antigen tests only pick up 40-60% of people who actually have COVID, but a PCR test is going to pick up 95-100% of people who have COVID,” said BYU public health professor Mary Davis.

Using the BioFire test kit is also more streamlined than other COVID-19 tests, and the simplicity creates less room for human error.

Samples are taken from patients using a nasal swab. The test requires only about two minutes of prep time, and results come within 45 minutes to an hour.

“BioFire has a really nice system,” Davis said. “It’s pretty hands-off. The BioFire is two minutes of hands-on time so there’s a lot less error there.”

The BioFire test stands apart from other tests because it tests for multiple strains of COVID-19 as well as dozens of other viral and bacterial pathogens responsible for respiratory infections.

“It is beneficial to be able to get a test result that might be COVID-negative, but which may also pinpoint another respiratory virus that is causing the symptoms,” said Joel Griffitts, BYU professor and department chair of microbiology and molecular biology.

BioFire has over 25 years of molecular experience. The company is a leader in syndromic infectious disease testing. This test is one of many of BioFire’s molecular diagnostic platforms.

“It really shows that you need scientists with creativity,” Davis said.

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