bioMérieux receives Dual 510(k) clearance and CLIA-waiver approval for the BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel ##

bioMérieux has received U.S. Food and Drug Administration (FDA) 510(k) clearance and Clinical Laboratory Improvement Amendments (CLIA) waiver approval for its BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel. This novel multiplex PCR test can detect and identify nucleic acids from up to 15 of the most common bacteria, viruses, and viral subtypes responsible for respiratory or sore throat infections in approximately 15 minutes. The test can be performed on a nasopharyngeal swab when a respiratory tract infection is suspected or on a throat swab in case of a pharyngitis syndrome. The CLIA-waiver designation allows the BIOFIRE® SPOTFIRE® System and its authorized panels to be used by non-lab professionals in any clinical setting, accelerating the diagnostic process and improving patient care.

The BIOFIRE® SPOTFIRE® R/ST Panel is the most recent panel to receive FDA clearance for use on the BIOFIRE® SPOTFIRE® System. The two other panels available on this system are theBIOFIRE®SPOTFIRE®Respiratory (R) Panel andBIOFIRE® SPOTFIRE®Respiratory (R) Panel Mini, detecting 15 and 5 of the most common respiratory pathogens, respectively. The BIOFIRE® SPOTFIRE® R/ST Panel is currently CE-marked under IVDD (In Vitro Diagnostic Directive) and has been submitted for CE-marking under IVDR (In Vitro Diagnostic Regulation). 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 5 of the most common viral and bacterial causes of respiratory tract infections from either a nasopharyngeal or throat swab3 respectively. The BIOFIRE® SPOTFIRE® R/ST Panel Mini is not yet available for sale.

polymerase chain reaction Under its FDA-cleared and CLIA-waved version, the BIOFIRE® SPOTFIRE® R/ST Panel is capable of testing:

Viruses: Adenovirus, Coronavirus (seasonal),, Human metapneumovirus, Human rhinovirus/enterovirus, Influenza A, Influenza A subtype H3, Influenza A subtype H1-2009, Influenza B virus, Parainfluenza virus, Respiratory syncytial virus. [Respiratory only]: Coronavirus SARS-CoV-2.

Bacteria: Chlamydia pneumoniae, Mycoplasma pneumoniae, [Respiratory only]: Bordetella pertussis, Bordetella parapertussis, [Sore Throat only]: Streptococcus dysgalactiae (group C/G Strep), Streptococcus pyogenes (group A Strep)

Viruses: Human rhinovirus, Influenza A virus, Influenza B virus, Respiratory syncytial virus. [Respiratory only]: Coronavirus SARS-CoV-2.

Bacteria: [Sore Throat only]: Streptococcus pyogenes (group A Strep)

bioMérieux is a pioneer in diagnostics and is present in 45 countries, serving more than 160 countries through a large network of distributors. The company provides diagnostic solutions (systems, reagents, software, and services) that determine the source of disease and contamination to improve patient health and ensure consumer safety. Revenues reached €3.7 billion in 2023, with over 90% of sales outside France.

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