Brahms PCT OK’d as aid in antibiotic stewardship
March 20, 2017—BioMérieux received 510(k) clearance from the Food and Drug Administration for the expanded use of its Vidas Brahms PCT, an automated assay measuring procalcitonin levels, to help clinicians make decisions about the use of antibiotics in two clinical situations: lower respiratory tract infections and sepsis.
It’s the first test to use PCT as a biomarker to aid in antibiotic management decisions. In the case of patients with lower respiratory tract infection, Vidas Brahms PCT will aid physicians in decision-making to safely reduce overall antibiotic use. In the case of sepsis patients, it will aid physicians in deciding when antibiotics can be safely discontinued.
“True to its pioneering spirit, BioMérieux worked with the FDA to develop a strategy which undertook a comprehensive evaluation of the published literature and conducted an in-depth analysis—termed a meta-analysis—to support the two new indications for use. These studies validated the vital role of Vidas Brahms PCT as an aid for antibiotic stewardship and the important role which diagnostic tests can play to curb the rise of multiresistant bacteria,” Sam Bozzette, vice president, Medical Affairs Americas, BioMérieux, said in a statement.