Rapid Diagnostic System to Deliver Same-Shift Antibiotic Susceptibility Test Results

The World Health Organization estimates that sepsis impacts around 49 million people worldwide each year, resulting in roughly 11 million deaths, with about 1.32 million of these deaths directly linked to bacterial antimicrobial resistance. Given the urgency, there's a growing need for rapid antimicrobial susceptibility testing (AST) that can guide the use of targeted antimicrobial therapies. Such testing is crucial for enhancing patient outcomes, reducing hospital costs, and curbing the rise of antimicrobial resistance. Now, a rapid AST system aims to deliver same-shift results, significantly aiding antimicrobial stewardship teams and clinicians in promptly customizing treatments for patients with severe infections.

The WAVE system from Accelerate Diagnostics (Tucson, AZ, US) is designed to deliver rapid AST results from positive blood culture (PBC) bottles and isolated bacterial colonies (isolates), delivering precise results in approximately 4.5 hours. Utilizing cutting-edge holographic imaging technology, the WAVE system tracks bacterial growth and morphology changes in real-time, thus allowing for quick, quantitative susceptibility test outcomes. It features a comprehensive test menu and integrates key functionalities to enhance laboratory workflows. The system's full random access capability supports continuous sample loading, making it adaptable for a wide range of healthcare environments, from small community hospitals to large academic and reference laboratories.

Accelerate Diagnostics has concluded a pre-clinical trial of the WAVE system, which involved a comparative analysis of 1,570 WAVE results against those obtained via broth microdilution, the gold standard reference method. The trial incorporated an equal mix of prospective patient samples and specifically chosen challenge samples, yielding high concordance rates between the different sample types. The trial's summary data showed an essential agreement and categorical agreement rate of about 95%, demonstrating the system's effectiveness.

“We are extremely pleased to announce the goals for our WAVE pre-clinical trial were achieved with strong performance and unprecedented time-to-result of 4.5-hours, on average, along with strong instrument reliability and assay reportability,” said Jack Phillips, President and CEO of Accelerate Diagnostics, Inc. “With the success of the pre-clinical trial we have confidence in both our WAVE product design and the system capabilities to move to a clinical trial and in turn commercialize.”

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