Accelerate Diagnostics Announces FDA Clearance of its Accelerate Arc™ System

Product Overview - The Accelerate Arc system is an automated platform designed for rapid microbial identification directly from positive blood culture samples, eliminating the need for overnight culture methods [1][2] - The system is FDA-cleared and works in conjunction with Bruker's MALDI Biotyper® CA System and MBT-CA Sepsityper® software extension [1] - It is designed to leverage Bruker's MBT-CA reference library for rapid identification, with future integration planned for the Accelerate WAVE™ system, which is currently in clinical trials [2][8] Clinical and Operational Benefits - The Accelerate Arc system reduces wait time for microbial identification results, which is critical in the fight against sepsis and antimicrobial resistance (AMR) [2] - By providing rapid identification and future antibiotic susceptibility testing (AST) results, clinicians can optimize antibiotic therapy sooner, improving patient outcomes and reducing hospital costs [2] - The system replaces labor-intensive Laboratory Developed Test (LDT) sample preparation methods, aligning with increased FDA regulations on LDT usage [3] Company Background - Accelerate Diagnostics, Inc is an in vitro diagnostics company focused on addressing antibiotic resistance and sepsis [4] - The company's product portfolio includes the Accelerate Pheno system and Accelerate PhenoTest® BC kit, which automate sample preparation, identification, and phenotypic antibiotic susceptibility testing in approximately seven hours [4] - External studies indicate that the Accelerate Pheno system provides results 1–2 days faster than existing methods, enabling earlier optimization of antibiotic therapy [4] Future Developments - The Accelerate WAVE™ system, currently in clinical trials, aims to achieve a target time-to-result of 4.5 hours on average, further enhancing rapid diagnostics capabilities [8]