Industry News: bioMérieux receives CLIA-waiver approval for the BIOFIRE SPOTFIRE

The respiratory/sore throat (R/ST) panel receives Dual 510(k) clearance and CLIA-waiver approval

02 Apr 2024

bioMerieux

bioMérieux, a world leader in the field of in vitro diagnostics, receives US Food and Drug Administration (FDA) 510(k) clearance and Clinical Laboratory Improvement Amendments (CLIA) waiver approval for the BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel.

The BIOFIRE SPOTFIRE R/ST Panel is a multiplex PCR test capable of detecting and identifying nucleic acids from up to 15 of the most common bacteria, viruses, and viral subtypes responsible for respiratory or sore throat infections in about 15 minutes. Samples can be taken from a nasopharyngeal swab when a respiratory tract infection is suspected, or from a throat swab in case of a pharyngitis syndrome.

The BIOFIRE SPOTFIRE R/ST Panel is the third panel to receive FDA clearance for use on the BIOFIRE SPOTFIRE System. The two other panels available for use on this system are the BIOFIRE SPOTFIRE Respiratory (R) Panel and BIOFIRE SPOTFIRE Respiratory (R) Panel Mini, detecting 15 and five of the most common respiratory pathogens respectively.

A CLIA-waiver allows the BIOFIRE SPOTFIRE System and its so-authorized panels to be used by non-lab professionals and in any clinical setting where patients seek care including an urgent care, physician office, local pharmacy, student health clinic, or an emergency department.

The BIOFIRE SPOTFIRE R/ST Panel is currently CE-marked under In Vitro Diagnostic Directive (IVDD) and has been submitted for CE-marking under In Vitro Diagnostic Regulation (IVDR). bioMérieux will also submit the BIOFIRE SPOTFIRE Respiratory / Sore Throat (R/ST) Panel Mini to the FDA for review for a 510(k) clearance. This panel is intended to detect and identify nucleic acids from five of the most common viral and bacterial causes of respiratory tract infections from either a nasopharyngeal or throat swab respectively. The BIOFIRE SPOTFIRE R/ST Panel Mini is not yet available for sale.

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