By IDSE News Staff
The FDA cleared two rapid diagnostic panels by bioMérieux—the Biofire Spotfire Respiratory/Sore Throat (R/ST) Panel Mini and the Vitek Reveal AST System.
The COVID-19 pandemic demonstrated the need for healthcare professionals to have diagnostic tests as close as possible to the patient and provide actionable results quickly. More tests are carried out outside hospital laboratories directly in Emergency Departments (ED) or at the Point of Care (POC).
For use on the Biofire Spotfire system, the R/ST R/ST Panel Mini is a unique multiplex polymerase chain reaction (PCR) test that detects five of the most common viral and bacterial causes of respiratory or sore throat infections 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 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, already FDA-cleared and CLIA-waived, or a small multiplex respiratory test with five pathogens with the new 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 Charles K. Cooper, MD, the executive vice-president, chief medical officer at bioMérieux.
The Vitek Reveal AST System can report results directly from positive blood cultures. The instrument integrates into bioMérieux’s unique and comprehensive portfolio of diagnostic solutions to address bloodstream infections and sepsis.
The modular Vitek Reveal AST system can deliver actionable results for gram- negative bacteria directly from positive blood cultures in an average of 5.5 to 6 hours enabling same-day treatment decision-making for patients suffering from bacteremic sepsis, according to a poster presented at the 32nd European Congress of Clinical Microbiology & Infectious Diseases, May 2022, held in Lisbon, Portugal.
In August 2022, the FDA granted the system a Breakthrough Device Designation, which is reserved for medical devices that offer significant advantages over existing cleared alternatives, for which no approved alternatives exist, and/or for which device availability is in the best interest of patients.
Every year 11 million people worldwide die of sepsis and 1.3 million of these deaths are attributable to antibiotic-resistant bacteria (Lancet 2022;399[10325]:629-655). For clinicians to rapidly optimize therapy and improve patient care, fast and accurate antimicrobial susceptibility testing (AST) results and interpretation are critical. In addition, fast AST can enable antimicrobial stewardship programs which has the potential to reduce antimicrobial resistance, identified as a global threat by WHO.
“Based on its unique, patented metabolomic signature technology, the Vitek Reveal AST System offers an easy-to-use instrument with a broad antimicrobial coverage, small footprint and modular design for adaptable throughput, well-suited to address the needs of clinical laboratories.” explained Jennifer Zinn, the vice president, clinical operations.
“By integrating this advanced technology in bioMérieux’s portfolio, we are increasing the ability of laboratories to deliver AST results as soon as possible, especially in cases of critical bacteremia-associated sepsis, which require urgent and appropriate treatment,” Dr. Charles K. Cooper added.
The company said the R/ST Panel Mini will be available in the third quarter 2024.
—From company press materials.
