French diagnostics company bioMerieux announced yesterday that it has received US Food and Drug Administration 510(k) clearance for a rapid respiratory/sore throat panel that company officials say will help clinicians make more informed decisions about antibiotic prescribing.
The panel, Biofire Spotfire, is a multiplex polymerase chain reaction (PCR) test capable of detecting and identifying nucleic acids from up to 15 of the most common bacteria, viruses, and viral subtypes that cause respiratory or sore throat infections in about 15 minutes. The test uses samples taken from nasopharyngeal and throat swabs.
"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," bioMérieux Executive Vice-President and Chief Medical Officer Charles K. Cooper, MD, said in a company press release. "These results further empower the advancement of antimicrobial stewardship and modernize patient care."
The company also received a Clinical Laboratory Improvement Amendments waiver for the test, which allows it to be used by non-lab professionals and in any setting where patients seek care.