Accelerate Diagnostics Submits WAVE System and Gram-Negative Positive Blood Culture Menu to the FDA for 510(k) Clearance
Accelerate Diagnostics (AXDX) has submitted its Accelerate WAVE™ system and positive blood culture gram-negative test kit to the FDA for 510(k) clearance. The WAVE system performs rapid antimicrobial susceptibility testing (AST) directly from positive blood culture bottles and bacterial isolate colonies, delivering results in approximately 4.5 hours.
The system features high throughput capacity, scalable design, and user-friendly workflow, aiming to provide microbiology laboratories with a comprehensive AST solution. This technology addresses a critical healthcare challenge, as sepsis affects 49 million people globally annually, causing 11 million deaths, with 1.32 million deaths attributed to bacterial antimicrobial resistance. In the U.S., sepsis represents a $62 billion annual healthcare cost.
Accelerate Diagnostics (AXDX) ha presentato il suo sistema Accelerate WAVE™ e il kit di test per colture ematiche positive gram-negative all'FDA per l'approvazione 510(k). Il sistema WAVE esegue test rapidi di suscettibilità antimicrobica (AST) direttamente dalle bottiglie di coltura ematica positive e dalle colonie di isolati batterici, fornendo risultati in circa 4,5 ore.
Il sistema presenta un'alta capacità di throughput, un design scalabile e un flusso di lavoro intuitivo, con l'obiettivo di fornire ai laboratori di microbiologia una soluzione completa per l'AST. Questa tecnologia affronta una sfida critica nel settore sanitario, poiché la sepsi colpisce 49 milioni di persone a livello globale ogni anno, causando 11 milioni di decessi, di cui 1,32 milioni attribuiti alla resistenza antimicrobica batterica. Negli Stati Uniti, la sepsi rappresenta un costo sanitario annuale di 62 miliardi di dollari.
Accelerate Diagnostics (AXDX) ha presentado su sistema Accelerate WAVE™ y el kit de prueba de cultivo sanguíneo positivo gramnegativo a la FDA para la autorización 510(k). El sistema WAVE realiza pruebas rápidas de susceptibilidad antimicrobiana (AST) directamente desde botellas de cultivo sanguíneo positivo y colonias de aislados bacterianos, entregando resultados en aproximadamente 4.5 horas.
El sistema cuenta con una alta capacidad de rendimiento, un diseño escalable y un flujo de trabajo fácil de usar, con el objetivo de proporcionar a los laboratorios de microbiología una solución integral para el AST. Esta tecnología aborda un desafío crítico en la atención médica, ya que la sepsis afecta a 49 millones de personas en todo el mundo anualmente, causando 11 millones de muertes, de las cuales 1.32 millones se atribuyen a la resistencia antimicrobiana bacteriana. En EE. UU., la sepsis representa un costo sanitario anual de 62 mil millones de dólares.
Accelerate Diagnostics (AXDX)는 Accelerate WAVE™ 시스템과 양성 혈액 배양 그람 음성 테스트 키트를 FDA에 510(k) 승인을 요청했습니다. WAVE 시스템은 양성 혈액 배양 병과 세균 분리 콜로니에서 직접 항균제 감수성 테스트(AST)를 신속하게 수행하며, 약 4.5시간 내에 결과를 제공합니다.
이 시스템은 높은 처리 용량, 확장 가능한 설계 및 사용자 친화적인 작업 흐름을 특징으로 하여 미생물학 실험실에 포괄적인 AST 솔루션을 제공하는 것을 목표로 합니다. 이 기술은 중요한 의료 문제를 해결하는 데 기여하며, 매년 4,900만 명이 세균성 패혈증에 영향을 받고, 1100만 명이 사망하며, 이 중 132만 명의 사망이 세균 항균제 내성에 기인합니다. 미국에서는 패혈증이 연간 620억 달러의 의료 비용을 차지합니다.
Accelerate Diagnostics (AXDX) a soumis son système Accelerate WAVE™ et son kit de test de culture sanguine positive gram-négatif à la FDA pour une autorisation 510(k). Le système WAVE effectue des tests rapides de sensibilité aux antimicrobiens (AST) directement à partir de flacons de culture sanguine positifs et de colonies d'isolats bactériens, fournissant des résultats en environ 4,5 heures.
Le système présente une capacité de traitement élevée, un design évolutif et un flux de travail convivial, visant à fournir aux laboratoires de microbiologie une solution complète pour l'AST. Cette technologie répond à un défi critique en matière de santé, car la sepsie touche 49 millions de personnes dans le monde chaque année, causant 11 millions de décès, dont 1,32 million attribués à la résistance antimicrobienne bactérienne. Aux États-Unis, la sepsie représente un coût annuel de soins de santé de 62 milliards de dollars.
Accelerate Diagnostics (AXDX) hat sein Accelerate WAVE™ System und das positive Blutkultur-Gram-negativ-Testkit zur FDA zur Genehmigung nach 510(k) eingereicht. Das WAVE-System führt schnelle Tests zur antimikrobiellen Empfindlichkeit (AST) direkt aus positiven Blutkulturflaschen und Bakterienisolaten durch und liefert Ergebnisse in etwa 4,5 Stunden.
Das System bietet eine hohe Durchsatzkapazität, ein skalierbares Design und einen benutzerfreundlichen Arbeitsablauf, mit dem Ziel, Mikrobiologielabors eine umfassende AST-Lösung zu bieten. Diese Technologie adressiert eine kritische Herausforderung im Gesundheitswesen, da Sepsis jährlich 49 Millionen Menschen weltweit betrifft und 11 Millionen Todesfälle verursacht, wobei 1,32 Millionen Todesfälle auf die antimikrobielle Resistenz von Bakterien zurückzuführen sind. In den USA verursacht Sepsis jährliche Gesundheitskosten von 62 Milliarden Dollar.
- FDA 510(k) submission completed for new WAVE system
- Rapid 4.5-hour result delivery compared to traditional methods
- Addresses $62 billion annual U.S. sepsis market
- High throughput capacity and scalable design
- FDA approval still pending
- No revenue generation until regulatory clearance
- Will face competition in the established AST market
Insights
Accelerate Diagnostics' submission of the WAVE system for FDA 510(k) clearance represents a significant milestone in addressing a critical clinical need. The technology's ability to deliver antimicrobial susceptibility testing results in 4.5 hours versus the traditional 2-3 days could fundamentally transform sepsis treatment protocols.
The clinical implications are substantial. Sepsis affects
From a technical perspective, the WAVE platform's direct-from-positive-blood-culture capability eliminates time-consuming culturing steps. The system's high throughput design with user-friendly workflow addresses practical laboratory implementation challenges that have hindered adoption of previous rapid diagnostic technologies.
For a micro-cap company with
This 510(k) submission marks a critical regulatory milestone for Accelerate Diagnostics' WAVE system. The 510(k) pathway requires demonstrating substantial equivalence to a legally marketed predicate device, typically making it less burdensome than the PMA pathway required for novel technologies.
The submission timing is noteworthy as the FDA has been increasingly focused on antimicrobial resistance solutions. The agency's emphasis on addressing this crisis potentially creates a favorable regulatory environment for technologies like the WAVE system that support antimicrobial stewardship.
While 510(k) reviews theoretically take 90 days, the actual clearance timeline often extends to 6-9 months, particularly for complex diagnostic systems. The submission includes both the instrument and the gram-negative test kit, suggesting Accelerate is pursuing a comprehensive initial market entry strategy rather than a phased approach.
For context, Accelerate's existing Pheno system received FDA clearance in 2017, indicating the company has experience navigating the regulatory process for similar technologies. The WAVE system appears positioned as a next-generation platform with enhanced capabilities, which could expand their addressable market.
Should clearance be granted, Accelerate would still face reimbursement hurdles and adoption challenges, but this submission represents a necessary and significant step toward commercialization in the US market. For a company of Accelerate's size, achieving regulatory milestones is particularly meaningful for validating their technology and business model.
The Accelerate WAVE system is designed to provide rapid antimicrobial susceptibility testing (AST) directly from positive blood culture bottles and bacterial isolate colonies. The WAVE system is designed to deliver accurate results in an average of 4.5 hours, enabling same shift targeted antimicrobial therapy for patients with serious infections.
With a user-friendly workflow, high throughput capacity, and scalable design, once approved by the FDA, the WAVE system will offer microbiology laboratories a comprehensive AST solution to meet a wide range of testing demands and hospital formulary needs.
According to the World Health Organization, sepsis affects an estimated 49 million people globally each year, resulting in approximately 11 million deaths.1 Of those, around 1.32 million deaths2 are attributed to bacterial antimicrobial resistance. Sepsis also represents the most significant cost burden to the
By delivering rapid AST results, the WAVE system is designed to support earlier, targeted antimicrobial therapy—improving patient outcomes, reducing hospital costs, and helping combat antimicrobial resistance.
References:
1. Rudd KE, Johnson SC, Agesa KM, Shackelford KA, Tsoi D, Kievlan DR, Colombara DV, Ikuta KS, Kissoon N, Finfer S, Fleischmann-Struzek C, Machado FR, Reinhart KK, Rowan K, Seymour CW, Watson RS, West TE, Marinho F, Hay SI, Lozano R, Lopez AD, Angus DC, Murray CJL, Naghavi M. Global, regional, and national sepsis incidence and mortality, 1990-2017: analysis for the Global Burden of Disease Study. Lancet. 2020 Jan 18;395(10219):200-211. doi: 10.1016/S0140-6736(19)32989-7.
2. Murray CJ. Global Burden of Bacterial Antimicrobial Resistance in 2019: A Systematic Analysis. The Lancet. 2022;399(10325):629-655. doi:https://doi.org/10.1016/S0140-6736(21)02724-0.
3. (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7017950/)
About Accelerate Diagnostics, Inc.
Accelerate Diagnostics, Inc. is an in-vitro diagnostics company dedicated to providing solutions for the global challenges of antibiotic resistance and sepsis. Accelerate Diagnostics' current portfolio of FDA-cleared platforms include the Accelerate Pheno system and Accelerate PhenoTest® BC kit as well as the Accelerate Arc™ system and BC kit. The Accelerate Pheno system and Accelerate PhenoTest® BC kit combine several technologies aimed at reducing the time clinicians must wait to determine the most optimal antibiotic therapy for deadly infections. This system fully automates sample preparation, identification and phenotypic antibiotic susceptibility testing in approximately seven hours directly from positive blood cultures. Recent external studies indicate this solution offers results 1-2 days faster than existing methods, enabling clinicians the ability to optimize antibiotic selection and dosage specific to the individual patient days earlier. Further, the Accelerate Arc™ system and BC kit provide a novel, automated positive blood culture sample preparation platform for use with Bruker's MALDI Biotyper® CA System (MBT-CA System) and MBT-CA Sepsityper® software extension. Designed for clinical laboratories, the Accelerate Arc system has a simple workflow that automates positive blood culture sample preparation for direct downstream microbial identification using Bruker's MBT-CA System. This innovation eliminates the need for overnight culture methods, reducing the wait time for microbial identification results, which is critical in the fight against sepsis.
© Copyright 2025 Accelerate Diagnostics, Inc. All Rights Reserved. The "ACCELERATE DIAGNOSTICS," "ACCELERATE PHENO," "ACCELERATE PHENOTEST," "ACCELERATE ARC" and "ACCELERATE WAVE" diamond shaped logos and marks are trademarks or registered trademarks of Accelerate Diagnostics, Inc. All other trademarks are the property of their respective owners.
For more information about the company, its products and technology, or recent publications, visit axdx.com.
Forward-Looking Statements
Certain statements made in this press release and the related conference call are forward-looking or may have forward-looking implications within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and the company intends that such forward-looking statements be subject to the safe harbors created thereby. These forward-looking statements, which can be identified by the use of words such as "may," "will," "expect," "believe," "anticipate," "estimate," or "continue," or variations thereon or comparable terminology, include but are not limited to, statements about: the WAVE system's expected performance, effectiveness, hospital and patient benefits, market interest, and eventual commercialization; FDA approval for the WAVE system, including our ability to fund operations through the commercial launch of the Wave system. Actual results or developments may differ materially from those projected or implied in these forward-looking statements due to significant risks and uncertainties, including, but not limited to: difficulties in resolving the company's continuing financial condition and ability to obtain additional capital to meet its financial obligations; and the company's ability to obtain any regulatory approvals in a timely manner. Other important factors that could cause the company's actual results to differ materially from those in its forward-looking statements include those discussed in the company's filings with the Securities and Exchange Commission (the "SEC"), including in the "Risk Factors" sections of the company's most recently filed periodic reports on Form 10-K and Form 10-Q and subsequent filings with the SEC. Except as required by federal securities laws, the company undertakes no obligation to update or revise these forward-looking statements to reflect new events, uncertainties or other contingencies. Forward-looking statements speak only as of the date they are made and should not be relied upon as representing the company's plans and expectations as of any subsequent date.
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FAQ
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