Biofire Spotfire R/ST Panel Gets 510(k) Clearance, CLIA-waiver Approval

bioMérieux received FDA 510(k) clearance and CLIA waiver approval for the Biofire Spotfire Respiratory/Sore Throat (R/ST) Panel.

The Biofire Spotfire R/ST Panel is a unique 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 infections² 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.

“To prescribe or not to prescribe antimicrobials is the age-old question for outpatient upper respiratory infections. The flexibility of this syndromic panel allows healthcare professionals to test for multiple pathogens with overlapping signs and symptoms, ultimately allowing the diagnostic to drive informed decision-making during the outpatient visit. These results further empower the advancement of antimicrobial stewardship and modernize patient care,” said Dr Charles K. Cooper, Executive Vice-President, Chief Medical Officer, bioMérieux.

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 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.

References/Notes

¹ Polymerase Chain Reaction

² 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)

³ 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)