Accelerate Diagnostics Announces FDA Clearance of its Accelerate Arc™ System
Accelerate Diagnostics (NASDAQ: AXDX) has received FDA 510(k) clearance for its Accelerate Arc system and BC kit, an automated platform for rapid microbial identification from positive blood culture samples. The system is designed to work with Bruker's MALDI Biotyper® CA System and MBT-CA Sepsityper® software extension, eliminating the need for overnight culture methods and reducing wait times for results.
The Accelerate Arc system aims to provide rapid identification leveraging Bruker's MBT-CA reference library. When combined with the future Accelerate WAVE™ system for rapid antibiotic susceptibility testing, it could enable same-shift reporting to Antimicrobial Stewardship teams and clinicians. This innovation is expected to improve patient outcomes in sepsis cases, reduce antimicrobial resistance rates, and lower hospital costs by enabling faster, optimal antibiotic therapy.
Accelerate Diagnostics (NASDAQ: AXDX) ha ricevuto l'approvazione FDA 510(k) per il suo Accelerate Arc system e il kit BC, una piattaforma automatizzata per l'identificazione microbica rapida da campioni di emocolture positivi. Il sistema è progettato per funzionare con il sistema MALDI Biotyper® CA di Bruker e l'estensione software MBT-CA Sepsityper®, eliminando la necessità di metodi di coltura notturna e riducendo i tempi di attesa per i risultati.
Il sistema Accelerate Arc mira a fornire un'identificazione rapida utilizzando la libreria di riferimento MBT-CA di Bruker. Quando combinato con il futuro sistema Accelerate WAVE™ per il test rapido della suscettibilità agli antibiotici, potrebbe consentire una relazione immediata ai team di Stewardship Antimicrobica e ai clinici. Questa innovazione si prevede possa migliorare gli esiti dei pazienti nei casi di sepsi, ridurre i tassi di resistenza antimicrobica e abbassare i costi ospedalieri permettendo una terapia antibiotica più rapida e ottimale.
Accelerate Diagnostics (NASDAQ: AXDX) ha recibido la aprobación 510(k) de la FDA para su sistema Accelerate Arc y kit BC, una plataforma automatizada para la identificación microbiana rápida a partir de muestras de cultivos sanguíneos positivos. El sistema está diseñado para trabajar con el sistema MALDI Biotyper® CA de Bruker y la extensión de software MBT-CA Sepsityper®, eliminando la necesidad de métodos de cultivo nocturno y reduciendo los tiempos de espera para los resultados.
El sistema Accelerate Arc tiene como objetivo proporcionar una identificación rápida aprovechando la biblioteca de referencia MBT-CA de Bruker. Cuando se combine con el futuro sistema Accelerate WAVE™ para pruebas rápidas de susceptibilidad a antibióticos, podría permitir informes en el mismo turno a los equipos de Stewardship Antimicrobiana y a los clínicos. Se espera que esta innovación mejore los resultados de los pacientes en casos de sepsis, reduzca las tasas de resistencia a los antimicrobianos y disminuya los costos hospitalarios al permitir una terapia antibiótica más rápida y óptima.
Accelerate Diagnostics (NASDAQ: AXDX)는 긍정적인 혈액 배양 샘플에서 빠른 미생물 식별을 위한 자동화 플랫폼인 Accelerate Arc 시스템 및 BC 키트에 대해 FDA 510(k) 승인을 받았습니다. 이 시스템은 Bruker의 MALDI Biotyper® CA 시스템 및 MBT-CA Sepsityper® 소프트웨어 확장과 함께 작동하도록 설계되어 있으며, 하룻밤 배양 방법의 필요성을 없애고 결과 대기 시간을 줄입니다.
Accelerate Arc 시스템은 Bruker의 MBT-CA 참조 라이브러리를 활용하여 빠른 식별을 제공하는 것을 목표로 합니다. 향후 Accelerate WAVE™ 시스템과 결합하면 항생제 감수성 테스트를 신속하게 수행할 수 있어 의료진과 항균성 관리 팀에 같은 교대 근무 중에 보고할 수 있게 됩니다. 이 혁신은 패혈증 사례에서 환자 결과를 개선하고 항균제 내성 비율을 줄이며 더 빠르고 최적화된 항생제 치료를 통해 병원 비용을 절감할 것으로 기대됩니다.
Accelerate Diagnostics (NASDAQ: AXDX) a reçu l'approbation 510(k) de la FDA pour son système Accelerate Arc et kit BC, une plateforme automatisée pour l'identification microbienne rapide à partir d'échantillons de cultures sanguines positives. Le système est conçu pour fonctionner avec le système MALDI Biotyper® CA de Bruker et l'extension logicielle MBT-CA Sepsityper®, éliminant ainsi la nécessité de méthodes de culture de nuit et réduisant les temps d'attente pour les résultats.
Le système Accelerate Arc vise à fournir une identification rapide en s'appuyant sur la bibliothèque de référence MBT-CA de Bruker. Lorsqu'il est associé au futur système Accelerate WAVE™ pour les tests rapides de susceptibilité aux antibiotiques, il pourrait permettre un rapport immédiat aux équipes de stewardship antimicrobienne et aux cliniciens. Cette innovation devrait améliorer les résultats des patients dans les cas de septicémie, réduire les taux de résistance aux antimicrobiens et diminuer les coûts hospitaliers en permettant une thérapie antibiotique plus rapide et optimale.
Accelerate Diagnostics (NASDAQ: AXDX) hat die FDA 510(k)-Genehmigung für sein Accelerate Arc-System und das BC-Kit erhalten, eine automatisierte Plattform zur schnellen mikrobiellen Identifizierung aus positiven Blutkulturproben. Das System ist so konzipiert, dass es mit Brukers MALDI Biotyper® CA-System und der MBT-CA Sepsityper®-Softwareerweiterung funktioniert, wodurch die Notwendigkeit für Übernachtungskulturmethoden entfällt und die Wartezeiten auf Ergebnisse verkürzt werden.
Das Accelerate Arc-System hat zum Ziel, eine schnelle Identifizierung zu ermöglichen, die auf Brukers MBT-CA-Referenzbibliothek basiert. In Kombination mit dem zukünftigen Accelerate WAVE™-System für schnelle Antibiotika-Empfindlichkeitstests könnte es eine sofortige Berichterstattung an die Teams für antimikrobielle Stewardship und Klinikern ermöglichen. Diese Innovation wird voraussichtlich die patientenbezogenen Ergebnisse bei Sepsisfällen verbessern, die Raten der antimikrobiellen Resistenzen senken und die Krankenhauskosten durch schnellere, optimale Antibiotikatherapie senken.
- FDA 510(k) clearance received for Accelerate Arc system and BC kit
- Automated platform reduces wait time for microbial identification results
- Potential for same-shift reporting when combined with future Accelerate WAVE™ system
- Designed to improve patient outcomes, reduce antimicrobial resistance, and lower hospital costs
- Accelerate WAVE™ system for antibiotic susceptibility testing is not yet available
Insights
The FDA clearance of Accelerate Diagnostics' Arc system is a significant development in the fight against sepsis and antimicrobial resistance. This automated platform for microbial identification from positive blood cultures could substantially reduce the time to obtain critical results, potentially improving patient outcomes and reducing healthcare costs.
Key points to consider:
- The system automates sample preparation, eliminating the need for overnight culture methods and potentially saving 12-24 hours in diagnosis time.
- Integration with Bruker's MALDI Biotyper CA System leverages an extensive reference library for rapid identification.
- This clearance positions Accelerate Diagnostics to offer an FDA-approved alternative to Laboratory Developed Tests, which face increasing regulatory scrutiny.
- The potential for same-shift reporting of both identification and antibiotic susceptibility testing results could significantly impact antimicrobial stewardship efforts.
While this clearance is promising, investors should note that the full impact on Accelerate Diagnostics' financial performance will depend on market adoption rates and the successful launch of complementary products like the Accelerate WAVE system for antibiotic susceptibility testing.
The FDA clearance of the Accelerate Arc system is a positive development for Accelerate Diagnostics (AXDX), potentially opening up new revenue streams and market opportunities. However, investors should consider several factors:
- Market Potential: The global sepsis diagnostics market is projected to reach
$1.1 billion by 2026, growing at a CAGR of8.5% . AXDX's new system could capture a significant share of this expanding market. - Competitive Advantage: The Arc system's automation and FDA clearance provide a competitive edge over manual methods and LDTs, potentially driving adoption in clinical laboratories.
- Financial Impact: While promising, the immediate financial impact may be AXDX reported a net loss of
$41.8 million in 2023 and it's important to monitor how quickly this new product can contribute to revenue growth and profitability. - Future Pipeline: The mention of the complementary Accelerate WAVE system suggests a broader product strategy, which could enhance long-term growth prospects.
Investors should watch for updates on initial sales, adoption rates and the timeline for additional product launches to gauge the full potential impact on AXDX's financial performance and market position.
An automated platform designed to fight against Sepsis and Antimicrobial Resistance (AMR)
Enables rapid, automated microbial identification on the Bruker MALDI Biotyper® CA System directly from positive blood culture samples
Designed for clinical laboratories, the Accelerate Arc system has a simple workflow that automates positive blood culture sample preparation for direct downstream microbial identification (ID) using Bruker's MBT-CA system. This eliminates the need for overnight culture methods, reducing the wait time for microbial ID results, which is critical in the fight against sepsis.
The Accelerate Arc system is designed to leverage the breadth of the Bruker MBT-CA reference library to provide rapid ID. This, in conjunction with our future rapid phenotypic antibiotic susceptibility testing (AST) innovation, the Accelerate WAVE™ system1, can enable same shift reporting to Antimicrobial Stewardship teams and clinicians alike. By providing clinicians with rapid ID and AST results, clinicians can get the patient on the optimal antibiotic therapy many hours sooner, which has been shown to improve patient outcomes with Sepsis, reduce antimicrobial resistance rates and hospital costs.
The Accelerate Arc system is also designed to supplant both overnight subculture as well as laborious Laboratory Developed Test (LDT) sample preparation methods. Clinical laboratories are under pressure to run FDA-cleared devices due to increased legislation and enforcement associated with the use of LDTs. Accordingly, such laboratories can now utilize the Accelerate Arc system as an automated, FDA-cleared system.
"The FDA Clearance of the Accelerate Arc system marks the beginning of an exciting journey in our broader innovation roadmap. Together with the Accelerate WAVE™ system1 we are positioned to empower laboratories to deliver faster, more actionable results to clinicians, ultimately enhancing patient care and outcomes." said Jack Phillips, President and CEO of Accelerate Diagnostics.
About Accelerate Diagnostics, Inc. (Nasdaq: AXDX)
Accelerate Diagnostics, Inc. is an in vitro diagnostics company dedicated to providing solutions for the global challenges of antibiotic resistance and sepsis. In addition to the Accelerate Arc system, 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. The FDA-cleared Accelerate Pheno system and Accelerate PhenoTest BC kit fully automate sample preparation, identification and phenotypic antibiotic susceptibility testing in approximately seven hours directly from positive blood cultures. Recent external studies indicate the solution offers results 1–2 days faster than existing methods, enabling clinicians to optimize antibiotic selection and dosage specific to the individual patient days earlier.
© Copyright 2024 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 of the statements made in this press release 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: expectations regarding the potential or benefits of Accelerate Diagnostics' products and technologies, including the Accelerate Arc system, such as the anticipated benefits to hospitals, patients, and laboratories, as well as the expectation that the Accelerate Arc system will eliminate the need for overnight culture methods and reduce the wait time for microbial identification results; expectations regarding new or planned products and technologies, including the anticipated timing of any releases, such as with respect to the Accelerate WAVE system currently under development; and intentions and plans relating to regulatory approvals or submission, including with respect to the FDA. 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: volatility throughout the global economy and the related impacts to the businesses of the company's suppliers and customers, whether due to customer demand fluctuations, supply chain constraints and inflationary pressures or otherwise; difficulties in resolving the company's continuing financial condition and ability to obtain additional capital to meet its financial obligations; the company's ability to obtain any regulatory approvals; and less than expected operating and financial benefits resulting from cost cutting measures. 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. These forward-looking statements are also based on certain additional assumptions, including, but not limited to, that the company will retain key management personnel; the company will be successful in the commercialization of its products; the company will obtain sufficient capital to commercialize its products and continue development of complementary products; the company will be successful in obtaining marketing authorization for its products from the FDA and other regulatory agencies and governing bodies; the company will be able to protect its intellectual property; the company's ability to respond effectively to technological change; the company's ability to accurately anticipate market demand for its products; and that there will be no material adverse change in the company's operations or business and general market and industry conditions. 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.
1 The Accelerate WAVETM system is currently in clinical trials in preparation for FDA 510(k) submission with a target time-to-result of 4.5-hours, on average.
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FAQ
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