Accelerate Diagnostics Submits WAVE System and Gram-Negative Positive Blood Culture Menu to the FDA for 510(k) Clearance

Core Viewpoint - Accelerate Diagnostics, Inc. has submitted its Accelerate WAVE™ system and positive blood culture gram-negative test kit to the FDA for 510(k) clearance, aiming to enhance rapid antimicrobial susceptibility testing and improve patient outcomes in serious infections [1][2][3]. Group 1: Product Overview - The Accelerate WAVE system is designed to provide rapid antimicrobial susceptibility testing directly from positive blood culture bottles and bacterial isolate colonies, delivering results in an average of 4.5 hours [2]. - Once approved, the WAVE system will offer microbiology laboratories a comprehensive solution to meet various testing demands and hospital formulary needs, featuring a user-friendly workflow and high throughput capacity [3]. Group 2: Market Context and Impact - Sepsis affects approximately 49 million people globally each year, leading to around 11 million deaths, with 1.32 million deaths attributed to bacterial antimicrobial resistance [4]. - The annual cost burden of sepsis on the U.S. healthcare system is estimated at $62 billion, highlighting the need for rapid AST results to support earlier targeted antimicrobial therapy, thereby improving patient outcomes and reducing hospital costs [4]. Group 3: Company Background - Accelerate Diagnostics, Inc. focuses on in-vitro diagnostics solutions addressing antibiotic resistance and sepsis, with existing FDA-cleared platforms including the Accelerate Pheno system and Accelerate PhenoTest® BC kit [6]. - The Accelerate Pheno system automates sample preparation, identification, and phenotypic antibiotic susceptibility testing in approximately seven hours, offering results 1-2 days faster than existing methods [6].