Accelerate Diagnostics Submits WAVE System for FDA Clearance

TUCSON, Ariz., March 21, 2025 /PRNewswire/ — Accelerate Diagnostics, Inc. AXDX, a leader in rapid in vitro diagnostics for microbiology, has announced the submission of 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.

Overview of the Accelerate WAVE System

The Accelerate WAVE system is engineered for rapid antimicrobial susceptibility testing (AST) directly from positive blood culture bottles and bacterial isolate colonies. It provides accurate results in an average time of 4.5 hours, allowing for same-shift targeted antimicrobial therapy for patients with serious infections.

Benefits for Microbiology Laboratories and Healthcare

Once FDA approved, the WAVE system will bring a user-friendly workflow, high throughput capacity, and scalable design to microbiology laboratories. This technology aims to meet various testing demands and enhance hospital formulary needs.

Impact of Sepsis and Antimicrobial Resistance

Sepsis affects approximately 49 million individuals worldwide each year, leading to roughly 11 million deaths, as reported by the World Health Organization. Of those fatalities, approximately 1.32 million are linked to bacterial antimicrobial resistance. The economic burden of sepsis on the U.S. healthcare system is significant, with estimated annual costs reaching $62 billion.

The WAVE system aims to provide rapid AST results, which facilitate earlier, targeted antimicrobial therapy. This advancement is expected to improve patient outcomes, decrease hospital expenses, and contribute to the fight against antimicrobial resistance.

Company Information

About Accelerate Diagnostics, Inc.

Accelerate Diagnostics, Inc. focuses on in-vitro diagnostics, addressing the challenges posed by antibiotic resistance and sepsis. The company’s portfolio includes FDA-cleared platforms like the Accelerate Pheno system and Accelerate PhenoTest® BC kit, as well as the Accelerate Arc™ system and BC kit. These innovations have been reported to significantly accelerate the identification and susceptibility testing of pathogens from positive blood cultures, improving timely clinical decision-making.

The Accelerate Arc™ system specifically automates positive blood culture sample preparation, offering clinical laboratories a streamlined workflow for microbial identification, crucial for timely sepsis management.

© Copyright 2025 Accelerate Diagnostics, Inc. All Rights Reserved. The “ACCELERATE DIAGNOSTICS,” “ACCELERATE PHENO,” “ACCELERATE PHENOTEST,” “ACCELERATE ARC,” and “ACCELERATE WAVE” logos are trademarks of Accelerate Diagnostics, Inc.

For further details about the company, its products, and technology, please visit axdx.com.

Forward-Looking Statements

Certain statements within this press release may be regarded as forward-looking, as defined under U.S. securities laws. These statements, identified by terminology such as “may,” “will,” “expect,” and similar expressions, pertain to the anticipated performance of the WAVE system, potential FDA approval, and related financial operations. Actual outcomes may differ significantly due to various risks, including challenges in obtaining necessary regulatory approvals and financial stability. For more details on risks and uncertainties, please refer to the company’s filings with the Securities and Exchange Commission (SEC).

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SOURCE Accelerate Diagnostics, Inc.