SALT LAKE CITY — A COVID-19 test developed in Utah and granted emergency use authorization in the early days of the pandemic last year has become the first such test to earn full U.S. Food and Drug Administration approval, the agency announced this week.
On Wednesday, the FDA said it had granted marketing authorization of the BioFire Respiratory Panel 2.1 , a diagnostic test for the detection and identification of multiple respiratory viral and bacterial infections obtained from individuals suspected of COVID-19 and other respiratory tract ailments.
FDA Acting Commissioner Dr. Janet Woodcock said the BioFire authorization will help pave the way for additional full authorizations of critical COVID-19 diagnostic tests.
“Today’s action is a great demonstration of the FDA’s work to protect the public health in emergency response situations and beyond,” Woodcock said in a statement. “We ensured there were tests made available quickly under Emergency Use Authorization and we continue to work with diagnostic manufacturers to take the next step of ensuring products are FDA reviewed for safety and effectiveness and authorized for marketing under our traditional premarket authorities.
“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 and look forward to working with developers of medical products to move their products through our traditional review pathways.”
Following the test’s FDA emergency approval in May 2020, BioFire said the panel allows health care providers to quickly identify patients with common respiratory pathogens as well as those with COVID-19 using one simple test. The BioFire panel takes approximately 45 minutes and tests samples gathered via nasal swab.
The BioFire test was approved through an FDA process specifically tailored for novel and groundbreaking medical products and devices and is the first U.S.-developed COVID-19 test procedure to earn full approval.
“The BioFire Respiratory Panel 2.1. was granted marketing authorization using the De Novo premarket review pathway,” said FDA press officer Lauren-Jei McCarthy. “This is a regulatory pathway for low- to moderate-risk devices of a new type. The grant of the De Novo request is important because it is the first SARS-CoV-2 diagnostic test that will be permitted to be marketed beyond the public health emergency.”
BioFire started out as small firm known as Idaho Technology before moving to Salt Lake City in 1999 to have better access to the University of Utah’s talent pool and research assets. The medical diagnostics company built enough success in U.S. markets to draw the attention of French biotech giant bioMérieux, which acquired BioFire in 2014.
The company, founded in 1963, can trace its roots back to 1897 when Marcel Mérieux studied with the founder of microbiology, Louis Pasteur. Based in Marcy l’Étoile, France, bioMérieux is now doing business in some 160 countries, had almost 13,000 employees worldwide at the end of 2020 and a current market capitalization of nearly $16 billion.
The company invested $100 million in a new, 285,000-square-foot Research Park facility for BioFire, the Alain Mérieux Center for Molecular Diagnostics, which opened its doors in 2017.
BioFire did not respond to multiple Deseret News requests for comment on the FDA approval announcement.