Accelerate Diagnostics Aims for FDA Clearance with WAVE System
Accelerate Diagnostics Aims High with WAVE System Submission
Accelerate Diagnostics, Inc. (Nasdaq: AXDX), a pioneer in the rapid in vitro diagnostics sector, has announced a crucial step in advancing microbiological testing by submitting its Accelerate WAVE™ system and positive blood culture gram-negative test kit to the U.S. Food and Drug Administration (FDA) for 510(k) clearance.
Innovative Features of the WAVE System
The Accelerate WAVE system is engineered to deliver rapid antimicrobial susceptibility testing (AST) directly from positive blood culture bottles as well as from bacterial isolate colonies. This advanced system promises accurate results in approximately 4.5 hours, allowing healthcare providers to initiate targeted antimicrobial therapies during the same clinical shift for patients suffering from serious infections.
Addressing Global Health Challenges
Every year, sepsis impacts an estimated 49 million individuals worldwide, tragically resulting in around 11 million deaths. Alarmingly, approximately 1.32 million of these fatalities are connected to bacterial antimicrobial resistance. Sepsis also represents a significant financial burden on healthcare systems, costing an estimated annual expense of $62 billion.
By providing rapid AST results, the WAVE system is strategically poised to enhance earlier targeted antimicrobial treatment, improving patient outcomes while also aiding in the fight against antimicrobial resistance.
The Bigger Picture: Antibiotic Resistance and Sepsis Management
Infectious diseases caused by resistant bacteria are a growing concern for healthcare providers globally. The integration of the WAVE system into clinical routines could lead to substantial advancements in how infections are diagnosed and treated, thereby improving public health outcomes. Rapid testing innovations like the WAVE system are needed now more than ever in combating the global threat of antibiotic resistance.
Enhancing Laboratory Diagnostics
Once the WAVE system receives FDA approval, it is expected to provide a highly efficient AST solution tailored for microbiology laboratories. With its user-friendly setup and capacity to handle numerous tests simultaneously, the system promises to streamline workflows in medical facilities, meeting diverse testing demands effectively.
About Accelerate Diagnostics, Inc.
Accelerate Diagnostics is dedicated to addressing critical challenges posed by antibiotic resistance and sepsis in global healthcare. Their existing portfolio of FDA-cleared solutions includes the Accelerate Pheno system and the Accelerate PhenoTest® BC kit, as well as the Accelerate Arc™ system and BC kit. Notably, the Accelerate Pheno system automates the process of sample preparation, identification, and antibiotic susceptibility testing, significantly reducing the time physicians must wait to determine optimal antibiotic therapies in severe cases.
Through continued innovation, Accelerate Diagnostics aims to improve patient care by expediting the identification of microbial pathogens responsible for infections, thus enabling timely and effective treatment.
Frequently Asked Questions
What is the WAVE system?
The WAVE system is a diagnostic tool designed to provide rapid antimicrobial susceptibility testing directly from positive blood cultures or bacterial isolates, optimizing patient treatment.
How does the WAVE system improve patient care?
By delivering test results in approximately 4.5 hours, the WAVE system allows for quicker decisions on targeted antimicrobial therapies, improving patient outcomes and reducing hospital stays.
Why is addressing antibiotic resistance important?
Antibiotic resistance poses significant risks to public health, contributing to increased mortality rates from infections that can become hard to treat, creating a pressing need for rapid testing technologies.
What are the implications of FDA clearance for the WAVE system?
If cleared by the FDA, the WAVE system will become available to clinical laboratories, enhancing their testing capabilities and enabling faster, more accurate diagnostics.
How has Accelerate Diagnostics contributed to the field?
Accelerate Diagnostics has developed several FDA-cleared platforms that aid healthcare professionals in rapidly diagnosing infections and determining effective treatments, addressing the pressing challenges of sepsis and antimicrobial resistance.
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