BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel Mini receives US FDA Special 510(k) clearance and CLIA-waiver
BIOFIRE® SPOTFIRE® R/ST Panel Mini is a fast, highly sensitive and targeted panel that tests for four of the most common respiratory viruses (including influenzas) and Streptococcus A, from one throat swab
12 Aug 2024
bioMérieux has announced that its BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel Mini has received US Food and Drug Administration (FDA) Special 510(k) clearance and CLIA-waiver (Clinical Laboratory Improvement Amendments).
For use on the BIOFIRE® SPOTFIRE® system, the BIOFIRE® SPOTFIRE® R/ST Panel Mini is a unique multiplex PCR test that detects five of the most common viral and bacterial causes of respiratory or sore throat infections1 in about 15 minutes. Samples can be taken from a nasopharyngeal swab when a respiratory tract infection is suspected or from a throat swab when pharyngitis is suspected.
The BIOFIRE® SPOTFIRE® system is a POC platform providing fast results and offering flexibility with the capability of running either a large multiplex respiratory test with up to 15 pathogens with the BIOFIRE® SPOTFIRE® R/ST Panel, already FDA-cleared and CLIA-waived, or a small multiplex respiratory test with five pathogens with the BIOFIRE® SPOTFIRE® R/ST Panel Mini. This flexibility allows clinicians to choose the right test for their patients.
The BIOFIRE® SPOTFIRE® R/ST Panel Mini is now the fourth panel of the BIOFIRE® SPOTFIRE® range to be FDA-cleared and CLIA-waived. When implementing decentralized testing, CLIA-waiver is key because it allows for this system and panels to be used by non-lab professionals in POC settings where patients may seek care such as urgent cares, physician offices, local pharmacies, student health clinics, or emergency departments.
The new BIOFIRE® SPOTFIRE® R/ST Panel Mini will be available in the third quarter of 2024 in the United States. It is intended to be commercialized together with the larger multiplex BIOFIRE® SPOTFIRE® R/ST Panel to further expand bioMérieux’s presence in the North American outpatient market.
References
1 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).
Want the latest science news straight to your inbox? Become a SelectScience member for free today>>