Accelerate Diagnostics, Inc. (Nasdaq: AXDX) has submitted its innovative Accelerate WAVE™ system and positive blood culture gram-negative test kit to the U.S. Food and Drug Administration (FDA) for 510(k) clearance, the company announced on March 21, 2025.
The WAVE system represents a significant advancement in antimicrobial susceptibility testing (AST), capable of delivering accurate results directly from positive blood culture bottles and bacterial isolate colonies in an average of just 4.5 hours. This rapid turnaround time would enable same-shift targeted antimicrobial therapy for patients with serious infections, potentially transforming treatment protocols for sepsis and other life-threatening bacterial infections.
Addressing a Global Health Crisis
Sepsis remains one of the most urgent challenges in global healthcare. According to World Health Organization data, sepsis affects approximately 49 million people worldwide annually, resulting in 11 million deaths. Of these fatalities, an estimated 1.32 million are attributed to bacterial antimicrobial resistance. Beyond the devastating human toll, sepsis imposes the most significant cost burden on the U.S. healthcare system, with annual expenses reaching an estimated $62 billion.
The WAVE system's ability to deliver rapid AST results could fundamentally change this landscape by supporting earlier, targeted antimicrobial therapy—potentially improving patient outcomes, reducing hospital costs, and helping combat the growing threat of antimicrobial resistance.
Technical Capabilities and Laboratory Integration
Designed with laboratory efficiency in mind, the WAVE system features a user-friendly workflow, high throughput capacity, and scalable design. Upon FDA approval, it would offer microbiology laboratories a comprehensive AST solution capable of meeting diverse testing demands and hospital formulary needs.
The system's design allows for direct testing from positive blood culture bottles, eliminating time-consuming intermediate steps in the diagnostic process. This streamlined approach could significantly reduce the time clinicians must wait to determine optimal antibiotic therapy for patients with serious infections.
Building on a Foundation of Innovation
The WAVE system joins Accelerate Diagnostics' existing portfolio of FDA-cleared platforms, which includes the Accelerate Pheno system, Accelerate PhenoTest® BC kit, and the Accelerate Arc™ system and BC kit. These technologies have already demonstrated the ability to deliver results 1-2 days faster than traditional methods, enabling clinicians to optimize antibiotic selection and dosage for individual patients much earlier in the treatment process.
The company's Arc system has successfully automated positive blood culture sample preparation for microbial identification, eliminating the need for overnight culture methods. The WAVE system would extend these capabilities specifically in the critical area of antimicrobial susceptibility testing.
Clinical and Economic Implications
If approved, the WAVE system could have far-reaching implications for clinical practice and healthcare economics. By enabling more rapid identification of effective antimicrobial treatments, the technology could reduce hospital stays, decrease mortality rates, and potentially slow the development of antimicrobial resistance through more targeted therapy.
The economic impact could be equally significant. With sepsis representing a $62 billion annual expense to the U.S. healthcare system, technologies that improve treatment efficiency and reduce complications could generate substantial cost savings while improving patient outcomes.
Regulatory Pathway and Future Outlook
The 510(k) submission represents a critical milestone in bringing the WAVE system to market. The clearance process typically involves demonstrating substantial equivalence to a legally marketed predicate device, suggesting the company has confidence in the system's performance relative to existing technologies.
While the timeline for potential FDA clearance remains uncertain, the submission signals Accelerate Diagnostics' continued commitment to addressing the urgent challenges of sepsis and antimicrobial resistance through innovative diagnostic solutions.
As antimicrobial resistance continues to rise globally, technologies that enable more precise and timely antibiotic selection may play an increasingly vital role in preserving the effectiveness of existing antimicrobial agents while improving outcomes for patients with serious bacterial infections.
