bioMérieux’s Biofire Spotfire Respiratory/Sore Throat (R/ST) Panel Mini received US FDA Special 510(k) clearance and CLIA-waiver, according to the company.
RT’s Three Key Takeaways
- BioMérieux’s Biofire Spotfire R/ST Panel Mini, a multiplex PCR test for detecting five common respiratory and sore throat pathogens, received FDA Special 510(k) clearance and CLIA-waiver, providing results in about 15 minutes.
- The Biofire Spotfire system offers flexibility for clinicians by allowing the use of either a large multiplex test for up to 15 pathogens or a smaller test for 5 pathogens, catering to patient-specific needs in various POC settings.
- The Biofire Spotfire R/ST Panel Mini, available in the third quarter of 2024, aims to enhance diagnostic accuracy and reduce antibiotic overuse by providing rapid, targeted results for common respiratory infections, expanding bioMérieux’s presence in the North American outpatient market.
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 unique 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 5 pathogens with the Biofire Spotfire R/ST Panel Mini. This flexibility allows clinicians to choose the right test for their patients.
“The medical community continues to bring enhanced technology closer to patients, allowing clinicians to have more information to make real-time decisions. Regarding strep throat, Group A Streptococcus accounts for approximately 20% of sore throat cases and has historically been diagnosed via antigen tests. Including it on this PCR panel with common viral causes of strep throat, including rhinovirus, represents a step forward in healthcare, ultimately increasing diagnostic yield and removing the need to reflex to culture in most patients,” said Dr Charles K. Cooper, Executive Vice-President, Chief Medical Officer.
The product 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.
“With our Biofire Spotfire R/ST Panel Mini, we bring a fast, highly sensitive and targeted panel to test for 4 of the most common respiratory viruses (including influenzas) and Streptococcus A, from one throat swab, all at the same time. Our offer meets the current needs of the growing decentralized, POC market bringing syndromic testing to the frontline of patient care. With this innovation, clinicians now can confidently tell their patients quickly what is making them sick and get them on the right treatment pathway, limiting the overuse of antibiotics.” commented Jennifer Zinn, Executive Vice President, Clinical Operations.
The diagnostic 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.
Notes
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)
