 Panel Mini has received Special 510(k) clearance and a CLIA-waiver from the U.S. Food and Drug Administration (FDA).){kind=link}
BioMérieux, a global leader in in vitro diagnostics, has announced that its BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel Mini has received Special 510(k) clearance and a CLIA-waiver from the U.S. Food and Drug Administration (FDA).
The COVID-19 pandemic highlighted the critical need for rapid diagnostic tests that can be administered close to the patient, enabling healthcare professionals to provide timely and actionable results. This has led to a surge in demand for Point of Care (POC) testing, especially in the United States. The BIOFIRE® SPOTFIRE® range addresses this need with its innovative syndromic testing solutions.
Designed for use with the BIOFIRE® SPOTFIRE® system, the new R/ST Panel Mini is a multiplex PCR test that can detect five common viral and bacterial pathogens responsible for respiratory and sore throat infections in approximately 15 minutes. The test can be performed using a nasopharyngeal swab for respiratory infections or a throat swab for pharyngitis.
The BIOFIRE® SPOTFIRE® system is a versatile POC platform that offers fast results and the flexibility to run either a comprehensive multiplex respiratory test for up to 15 pathogens with the previously FDA-cleared and CLIA-waived BIOFIRE® SPOTFIRE® R/ST Panel, or a smaller test for five pathogens with the new R/ST Panel Mini. This allows clinicians to choose the most appropriate test for their patients.
Dr. Charles K. Cooper, Executive Vice-President and Chief Medical Officer, highlighted the significance of this advancement: “The integration of Group A Streptococcus with common viral causes of sore throat on this PCR panel represents a step forward in healthcare. This increases diagnostic yield and reduces the need for reflex culture in most patients.”
The BIOFIRE® SPOTFIRE® R/ST Panel Mini is the fourth panel in the BIOFIRE® SPOTFIRE® range to receive FDA clearance and a CLIA-waiver. The CLIA-waiver is crucial for decentralized testing, as it allows non-laboratory professionals to use the system and panels in various POC settings such as urgent care centers, physician offices, pharmacies, student health clinics, and emergency departments.
Jennifer Zinn, Executive Vice President of Clinical Operations, stated, “Our BIOFIRE® SPOTFIRE® R/ST Panel Mini provides a fast, highly sensitive, and targeted test for four common respiratory viruses and Streptococcus A from a single throat swab. This innovation meets the growing needs of the decentralized POC market, enabling clinicians to quickly identify the cause of illness and prescribe the right treatment, thereby reducing unnecessary antibiotic use.”
The BIOFIRE® SPOTFIRE® R/ST Panel Mini will be available in the U.S. in the third quarter of 2024. It will be marketed alongside the larger BIOFIRE® SPOTFIRE® R/ST Panel, enhancing bioMérieux’s presence in the North American outpatient market.