FDA APPROVA UN NUOVO KIT PER L'IDENTIFICAZIONE DI PATOGENI E SENSIBILITA' AGLI ANTIBIOTICI

Doctor 33 - La (Fda) Food and Drug Administration, statunitense, ha concesso l'autorizzazione all'immissione sul mercato per il Kit PhenoTest BC, prodotto da Accelerate Diagnostics Inc. di Tucson, in Arizona. Accelerate ➜ today announced that the U.S. Food and Drug Administration has granted the de novo request to market the Accelerate Pheno™ system and Accelerate PhenoTest™ BC kit for identification and antibiotic susceptibility testing of pathogens directly from positive blood culture samples. The blood culture kit is indicated for susceptibility testing of specific pathogenic bacteria commonly associated with bacteremia, the leading cause of sepsis.The Centers for Disease Control and Prevention estimate at least 2 million people each year are infected with antibiotic resistant bacteria across the U.S. In addition, antibiotic resistance contributes to the morbidity and mortality of healthcare-associated infections (HAI) that kill an estimated 75,000 people annually...>>>