bioMérieux receives FDA 510(k) Clearance for its VITEK® COMPACT PRO, a new ID/AST system to fight against antimicrobial resistance
bioMérieux (BMXXY) has received FDA 510(k) clearance for VITEK® COMPACT PRO, an advanced system for microorganism identification (ID) and antibiotic susceptibility testing (AST). This innovative solution aims to combat antimicrobial resistance and help diagnose infectious diseases in clinical laboratories while also supporting industrial laboratories in identifying contaminants for consumer safety.
The system builds upon its predecessor VITEK® 2 COMPACT, featuring enhanced ergonomic design and simplified workflow that reduces sample loading and processing time. Targeting small and medium-sized laboratories, VITEK® COMPACT PRO offers efficient workflows and rapid ID/AST results.
The commercial launch is scheduled to begin in select countries, followed by a global rollout starting in Q2 2025. The system addresses critical healthcare challenges, considering that 11 million people worldwide die of sepsis annually, with 1.3 million deaths attributed to antibiotic-resistant bacteria.
bioMérieux (BMXXY) ha ricevuto l'approvazione 510(k) dalla FDA per il VITEK® COMPACT PRO, un sistema avanzato per l'identificazione dei microorganismi (ID) e il test di suscettibilità agli antibiotici (AST). Questa soluzione innovativa mira a combattere la resistenza antimicrobica e a contribuire alla diagnosi di malattie infettive nei laboratori clinici, supportando anche i laboratori industriali nell'identificazione di contaminanti per la sicurezza dei consumatori.
Il sistema si basa sul suo predecessore VITEK® 2 COMPACT, con un design ergonomico migliorato e un flusso di lavoro semplificato che riduce i tempi di caricamento e di elaborazione dei campioni. Rivolto a laboratori di piccole e medie dimensioni, il VITEK® COMPACT PRO offre flussi di lavoro efficienti e risultati rapidi per ID/AST.
Il lancio commerciale è previsto in alcuni paesi selezionati, seguito da una diffusione globale a partire dal secondo trimestre del 2025. Il sistema affronta sfide sanitarie critiche, considerando che 11 milioni di persone nel mondo muoiono ogni anno di sepsi, con 1,3 milioni di decessi attribuiti a batteri resistenti agli antibiotici.
bioMérieux (BMXXY) ha recibido la aprobación 510(k) de la FDA para el VITEK® COMPACT PRO, un sistema avanzado para la identificación de microorganismos (ID) y pruebas de susceptibilidad a antibióticos (AST). Esta solución innovadora tiene como objetivo combatir la resistencia antimicrobiana y ayudar a diagnosticar enfermedades infecciosas en laboratorios clínicos, al mismo tiempo que apoya a laboratorios industriales en la identificación de contaminantes para la seguridad del consumidor.
El sistema se basa en su predecesor VITEK® 2 COMPACT, con un diseño ergonómico mejorado y un flujo de trabajo simplificado que reduce el tiempo de carga y procesamiento de muestras. Dirigido a laboratorios pequeños y medianos, el VITEK® COMPACT PRO ofrece flujos de trabajo eficientes y resultados rápidos de ID/AST.
El lanzamiento comercial está programado para comenzar en países seleccionados, seguido de un despliegue global que comenzará en el segundo trimestre de 2025. El sistema aborda desafíos críticos en salud, considerando que 11 millones de personas en todo el mundo mueren anualmente por sepsis, con 1,3 millones de muertes atribuidas a bacterias resistentes a antibióticos.
bioMérieux (BMXXY)는 VITEK® COMPACT PRO에 대해 FDA 510(k) 승인을 받았습니다. 이 고급 시스템은 미생물 식별(ID) 및 항생제 감수성 테스트(AST)를 위한 것입니다. 이 혁신적인 솔루션은 항균제 내성을 퇴치하고 임상 실험실에서 감염병 진단을 돕는 것을 목표로 하며, 소비자 안전을 위한 오염물질 식별을 지원하는 산업 실험실에도 도움이 됩니다.
이 시스템은 이전 모델인 VITEK® 2 COMPACT를 기반으로 하며, 샘플 로딩 및 처리 시간을 줄이는 향상된 인체공학적 디자인과 간소화된 작업 흐름을 특징으로 합니다. 소규모 및 중규모 실험실을 대상으로 하는 VITEK® COMPACT PRO는 효율적인 작업 흐름과 신속한 ID/AST 결과를 제공합니다.
상업적 출시는 일부 선정된 국가에서 시작될 예정이며, 2025년 2분기부터 글로벌 롤아웃이 시작됩니다. 이 시스템은 매년 전 세계에서 1100만 명이 패혈증으로 사망하고, 130만 명의 사망이 항생제 내성 박테리아에 기인한다는 점을 고려하여 중요한 의료 문제를 다룹니다.
bioMérieux (BMXXY) a reçu l'autorisation 510(k) de la FDA pour le VITEK® COMPACT PRO, un système avancé pour l'identification des microorganismes (ID) et le test de sensibilité aux antibiotiques (AST). Cette solution innovante vise à lutter contre la résistance antimicrobienne et à aider au diagnostic des maladies infectieuses dans les laboratoires cliniques, tout en soutenant également les laboratoires industriels dans l'identification des contaminants pour la sécurité des consommateurs.
Le système s'appuie sur son prédécesseur VITEK® 2 COMPACT, avec un design ergonomique amélioré et un flux de travail simplifié qui réduit le temps de chargement et de traitement des échantillons. Destiné aux laboratoires de petite et moyenne taille, le VITEK® COMPACT PRO offre des flux de travail efficaces et des résultats rapides pour l'ID/AST.
Le lancement commercial est prévu dans certains pays sélectionnés, suivi d'un déploiement mondial à partir du deuxième trimestre 2025. Le système répond à des défis critiques en matière de santé, sachant que 11 millions de personnes dans le monde meurent chaque année de sepsie, avec 1,3 million de décès attribués à des bactéries résistantes aux antibiotiques.
bioMérieux (BMXXY) hat die FDA 510(k) Zulassung für das VITEK® COMPACT PRO erhalten, ein fortschrittliches System zur Identifizierung von Mikroorganismen (ID) und zur Prüfung der Antibiotikaempfindlichkeit (AST). Diese innovative Lösung zielt darauf ab, der antimikrobiellen Resistenz entgegenzuwirken und bei der Diagnose von Infektionskrankheiten in klinischen Laboren zu helfen, während sie auch industrielle Labore bei der Identifizierung von Verunreinigungen zur Verbrauchersicherheit unterstützt.
Das System baut auf seinem Vorgänger VITEK® 2 COMPACT auf und bietet ein verbessertes ergonomisches Design sowie einen vereinfachten Arbeitsablauf, der die Probenbeladungs- und Verarbeitungszeit verkürzt. Das VITEK® COMPACT PRO richtet sich an kleine und mittelgroße Labore und bietet effiziente Arbeitsabläufe sowie schnelle ID/AST-Ergebnisse.
Der kommerzielle Start ist in ausgewählten Ländern geplant, gefolgt von einer globalen Einführung, die im 2. Quartal 2025 beginnen soll. Das System adressiert kritische Herausforderungen im Gesundheitswesen, da jährlich weltweit 11 Millionen Menschen an Sepsis sterben, wobei 1,3 Millionen Todesfälle auf antibiotikaresistente Bakterien zurückzuführen sind.
- FDA 510(k) clearance received for new diagnostic system
- Improved efficiency with reduced sample loading and processing time
- Expansion into small and medium-sized laboratory market segment
- Dual application for both clinical and industrial use
- None.
MARCY L'ÉTOILE,
Every year 11 million people worldwide die of sepsis1 and 1.3 million of these deaths are attributable to antibiotic-resistant bacteria2. Antimicrobial resistance (AMR) continues unabated making detection of resistant pathogens more complex. Clinicians need to receive accurate identification and faster antibiotic susceptibility test (AST) results, to enable timely and optimized patient intervention.
For over 30 years as a global leader in automated ID/AST systems, bioMérieux continues to collaborate with laboratory professionals and clinicians to innovate microbiology solutions for improved patient health management, operating cost efficiencies, and effective antimicrobial stewardship (AMS).
VITEK® COMPACT PRO combines the latest diagnostic technology with the globally acknowledged advantages of its predecessor: VITEK® 2 COMPACT. With an ergonomically advanced design and a simplified workflow, it further enhances the user experience and improves overall efficiency as the laboratory technician has to spend less time for sample loading and processing3. It offers one of the most efficient workflows, fastest routine ID/AST results and microbiology expertise for accurate and confident diagnostics insights4. Ideally suited for small and medium-sized laboratories, VITEK® COMPACT PRO will also enable laboratories transitioning from manual workflows to benefit from automation efficiencies.
"For decades, bioMérieux has been an industry leader in microbiology innovation. With the introduction of VITEK® COMPACT PRO, we are continuing this journey and delivering on the specialized needs of our customers – supporting laboratories with simplified, efficient workflows and the latest technology to optimize their experience. Through ongoing expansion of our VITEK® solutions portfolio, bioMérieux continues to strengthen our comprehensive AMR/AMS offer and reinforce our commitment to provide next-generation ID/AST systems to healthcare and laboratory professionals around the world," commented Jennifer Zinn, Executive Vice President, Clinical Operations.
"As a leader in the fight against AMR, bioMérieux continuously innovates by developing and renewing its key diagnostic solutions. VITEK® COMPACT PRO delivers fast, accurate and reproducible results comparable to VITEK® 2 and VITEK® 2 COMPACT systems. The ergonomic features, a new intuitive user interface, and an updated software with one of the most comprehensive knowledge database makes VITEK® COMPACT PRO highly appealing to both clinical and industrial laboratories." added Céline Roger-Dalbert, Executive Vice President, Research and Development.
For industrial applications, VITEK® COMPACT PRO will be used for routine identification of pathogens to ensure the quality and safety of food, pharmaceutical, and cosmetic products.
The commercial launch of VITEK® COMPACT PRO is initially planned in select countries, followed by global launch starting in the second quarter of 2025.
1 Rudd KE, Johnson SC, Agesa KM, Shackelford KA, Tsoi D, Kievlan DR, et al. Global, regional, and national sepsis incidence and mortality, 1990-2017: analysis for the Global Burden of Disease Study. Lancet (
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 bioMérieux proprietary data on file: VITEK® COMPACT PRO vs. VITEK® 2 COMPACT
4 Decarli A et al. JMM. 2022; 71:001543; bioMérieux proprietary data on file; Rommler W et al. ASM 2006; Poster C-123; Heller-Ono A Seln. of Publications VITEK® 2: bioMérieux White Paper 2008; Lombardi Vincent J, Seln. of Publications VITEK® 2: bioMerieux White Paper 2011; Hooper M et al. ECCMID 2013; Poster P-1536; Carvalhaes CG et al. ECCMID 2023 Poster # P0384.
ABOUT BIOMÉRIEUX'S COMPLETE ANTIMICROBIAL STEWARDSHIP (AMS) SOLUTION
bioMérieux's healthcare mission is to help sustain the use of antibiotic efficacy for generations to come.
To support hospitals, institutions, and laboratories with their AMS programs, bioMérieux has a complete solution covering antibiotic therapy initiation, optimization, and discontinuation. This constantly evolving offer provides timely, accurate results to adjust therapy, transforms data into actionable insights, and integrates smoothly into any hospital with its flexible partnership approach. bioMérieux has more than 60 years of microbiology expertise with
ABOUT BIOMÉRIEUX
Pioneering Diagnostics
A world leader in the field of in vitro diagnostics since 1963, bioMérieux is present in 45 countries and serves more than 160 countries with the support of a large network of distributors. In 2024, revenues reached
bioMérieux provides diagnostic solutions (systems, reagents, software, and services) which determine the source of disease and contamination to improve patient health and ensure consumer safety. Its products are mainly used for diagnosing infectious diseases. They are also used for detecting microorganisms in food, pharmaceutical and cosmetic products.
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