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Accelerate Diagnostics, Inc. AXDX has secured FDA 510(k) clearance for its Accelerate Arc system and BC kit, designed for use with Bruker's MALDI Biotyper CA system (MBT-CA System) and MBT-CA Sepsityper software extension.
Accelerate Diagnostics' automated platform simplifies the preparation of positive blood culture samples for direct microbial identification using Bruker's MBT-CA system, removing the overnight culture requirement. The Arc system reduces wait times for critical diagnostic results, which is essential in sepsis treatment.
Accelerate Diagnostics completed the WAVE pre-clinical trial for its innovative WAVE system, which provides rapid antimicrobial susceptibility testing (AST) directly from positive blood culture bottles and isolated colonies.With sepsis affecting an estimated 49 million people globally each year and leading to around 11 million deaths, the WAVE system aims to enhance patient outcomes by enabling timely targeted antimicrobial therapy. This rapid testing not only improves patient care but also has the potential to reduce healthcare costs and combat antimicrobial resistance, addressing a critical challenge in the healthcare system.
Likely Trend of AXDX Stock Following the News
Following the news, shares of AXDX declined 2.8% to $1.71 at yesterday’s closing.
Shares of Accelerate Diagnostics have plunged 56.4% year to date against the industry’s 8.9% growth. The S&P 500 has risen 20.5% in the same time frame.
Image Source: Zacks Investment Research
Despite the recent price decline, the FDA clearance of Accelerate Diagnostics' Arc system marks a positive shift in sentiment. The company, known for addressing antibiotic resistance and sepsis, has strengthened its portfolio with the Accelerate Arc system. Along with the already FDA-approved Pheno system and PhenoTest BC kit, these technologies aim to reduce the time clinicians need to identify optimal antibiotic therapies for life-threatening infections.This recent clearance reinforces the company's commitment to enhancing patient care and boosting clinical efficiency.
Significance of AXDX’s Arc System Gaining FDA Clearance
The FDA clearance of the Accelerate Arc system represents a key advancement in rapid diagnostics, offering faster identification of bloodborne pathogens.
The Accelerate Arc system utilizes the extensive Bruker MBT-CA reference library to deliver quicker microbial identification and potentially integrate with the future Accelerate WAVE system for antibiotic susceptibility testing. The Arc system enables clinicians to administer appropriate treatments sooner, enhancing sepsis outcomes, lowering antimicrobial resistance and reducing hospital costs. This system also addresses regulatory pressures on labs to adopt FDA-cleared devices, providing an efficient, automated alternative to traditional methods.