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bioMérieux announces FDA 510(k) clearance of game-changing, Utah-made diagnostic platform

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Global diagnostics company bioMérieux recently received FDA 510(k) clearance and Clinical Laboratory Improvement Amendments for an innovative approach to diagnostics. This milestone continues the company’s mission to expand technology out of traditional laboratory settings and into locations closer to patients like urgent care and physician offices.

The BIOFIRE® SPOTFIRE® System and its BIOFIRE® SPOTFIRE® Respiratory (R) Panel allow healthcare professionals to deliver results to patients suspected of respiratory tract infections in approximately 15 minutes. On top of its speed, the BIOFIRE® SPOTFIRE® R Panel can detect 15 different bacteria, viruses and viral subtypes behind respiratory infections—including SARS-CoV-2, Influenza A and B, and RSV.

SpotFire is the first and only diagnostic platform with SARS-CoV-2 and 14 other respiratory pathogens to receive FDA-clearance and CLIA-waiver. As the pandemic showed, there is tremendous clinical value associated with having fast, accurate, and easy-to-use diagnostics as close to the patient as possible—CLIA-waived support just that. For the first time ever, clinicians have the power of core lab quality multiplex testing in their clinics, right next to their patients, in about 15 minutes.

The company, based in France, has offices in Utah through its 2013 acquisition of BioFire Diagnostics, a University of Utah spinout company.

“The University of Utah is thrilled at the launch of the bioMérieux BIOFIRE® SPOTFIRE® System and its Respiratory Panel and is proud to be a part of this breakthrough technology’s origin story,” said University of Utah Chief Innovation and Economic Engagement Officer Keith Marmer. “We look forward to our continued partnership with bioMérieux, the leader in syndromic testing, to bring this cutting-edge technology to patients and clinicians.”

bioMérieux has taken a play out of its historical playbook by continuing to collaborate with the University of Utah. SpotFire, utilizes the Extreme PCR technology developed by Carl Wittwer and Jared Farrar at the University of Utah.  The SpotFire instrument uses US Patent Nos. 9,932,634 and 10,144,960, while the R Panel uses US Patent Nos. 9,932,634 and 11,021,744.  bioMerieux has exclusive rights to these patents, which enable PCR in under 10 seconds per cycle.

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