Accelerate Diagnostics has successfully completed the preclinical trial for its WAVE antimicrobial susceptibility testing system.
The Accelerate WAVE system is designed to perform rapid antimicrobial susceptibility testing (AST) directly from positive blood culture bottles and bacterial isolates, delivering accurate results within approximately 4.5 hours.
Rapid AST results can combat antimicrobial resistance by enabling targeted antimicrobial therapy. In turn, this can prevent complications from sepsis, help improve patient outcomes, and reduce hospital costs.
Sepsis affects approximately 49 million people globally each year, resulting in around 11 million deaths, with 1.32 million attributed to antimicrobial resistance, according to the World Health Organization. Sepsis is the most expensive condition for the U.S. healthcare system, costing an estimated $62 billion annually.
"With the success of the preclinical trial, we have confidence in both our WAVE product design and the system capabilities to move to a clinical trial and in turn commercialize," Jack Phillips, president and CEO of Tuczon, AZ-based Accelerate Diagnostics, said.
The preclinical trial compared 1,570 WAVE results compared to results using Broth Microdilution, the reference method, using both prospective patient samples and site-selected challenge samples. The trial demonstrated excellent concordance between sample types, with both overall essential agreement and categorical agreement of approximately 95%.
The WAVE system offers a comprehensive test menu, as well as features designed to optimize laboratory workflow. It supports full random access for continuous sample loading and is scalable to meet the needs of different healthcare settings and reference labs. WAVE uses novel holographic imaging technology to monitor bacterial growth and morphology changes in real time.