Accelerate Diagnostics (AXDX) Completes WAVE Pre-Clinical Trial

Core Insights - Accelerate Diagnostics, Inc. (AXDX) has successfully completed the pre-clinical trial of its WAVE system, demonstrating strong performance and reliability, which positions the company to advance to clinical trials and commercialization [1][4] Company Developments - The WAVE system is designed for rapid antimicrobial susceptibility testing (AST) from positive blood culture bottles and bacterial isolates, providing results in an average of 4.5 hours [2] - The pre-clinical trial involved 1,570 WAVE results compared to the Broth Microdilution reference method, achieving an overall Essential Agreement (EA) and Categorical Agreement (CA) of approximately 95% [4] - In April 2024, the company announced a 510(k) submission to the FDA for its Accelerate Arc system and BC kit, which is an automated platform for positive blood culture sample preparation [7] Industry Context - The global Antimicrobial Susceptibility Testing market was valued at $3.79 billion in 2023 and is projected to reach $5.69 billion by 2031, growing at a CAGR of 5.2%, driven by the increasing burden of antimicrobial resistance and the rise in infectious diseases [5] - The World Health Organization estimates that sepsis affects 49 million people globally each year, leading to approximately 11 million deaths, with significant healthcare costs in the U.S. reaching around $62 billion [3] Market Performance - Year to date, shares of AXDX have decreased by 55.3%, contrasting with the industry growth of 4.7% [8] - Accelerate Diagnostics currently holds a Zacks Rank 2 (Buy), indicating positive market sentiment [9]