bioMérieux, a world leader in the field of in vitro diagnostics, announces the U.S. Food and Drug Administration (FDA) 510(k) clearance for VITEK® COMPACT PRO. This innovative system for microorganism identification (ID) and antibiotic susceptibility testing (AST) will benefit clinical laboratories to help diagnose infectious diseases and combat antimicrobial resistance, and industrial laboratories to identify contaminants for ensuring consumer safety.

体外诊断领域的全球领导者 bioMérieux宣布 VITEK ® COMPACT PRO 已获得美国食品药品监督管理局 (FDA) 510(k) 批准。这种用于微生物鉴定 (ID) 和抗生素敏感性测试 (AST) 的创新系统将帮助临床实验室诊断传染病和对抗抗菌素耐药性，并帮助工业实验室识别污染物以确保消费者安全。

Every year 11 million people worldwide die of sepsis

每年全球有1100万人死于败血症

and 1.3 million of these deaths are attributable to antibiotic-resistant bacteria

其中130万例死亡是由耐药细菌导致的。

. 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.

. 抗微生物药物耐药性（AMR）持续加剧，使得耐药病原体的检测变得更加复杂。临床医生需要获得准确的鉴定和更快速的抗生素敏感性测试（AST）结果，以实现及时且优化的患者干预。

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).

三十多年来，作为自动ID/AST系统的全球领导者，生物梅里埃继续与实验室专业人员和临床医生合作，创新微生物解决方案，以改善患者健康管理、降低运营成本，并实施有效的抗菌药物管理 (AMS)。

COMPACT PRO combines the latest diagnostic technology with the globally acknowledged advantages of its predecessor: VITEK

COMPACT PRO 将最新的诊断技术与全球公认的其前身 VITEK 的优势相结合。

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 processing

2 COMPACT。凭借人体工程学的先进设计和简化的操作流程，它进一步提升了用户体验，并提高了整体效率，因为实验室技术人员在样品装载和处理上花费的时间更少。

. It offers one of the most efficient workflows, fastest routine ID/AST results and microbiology expertise for accurate and confident diagnostics insights

它提供了最高效的工作流程之一，最快的常规ID/AST结果以及准确和自信诊断所需的微生物学专业知识。

. Ideally suited for small and medium-sized laboratories, VITEK

。非常适合小型和中型实验室，VITEK

COMPACT PRO will also enable laboratories transitioning from manual workflows to benefit from automation efficiencies.

COMPACT PRO 还将使从手动工作流程过渡的实验室受益于自动化的效率。

'For decades, bioMérieux has been an industry leader in microbiology innovation. With the introduction of VITEK

“几十年来，生物梅里埃一直是微生物学创新的行业领导者。随着VITEK的引入，

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

COMPACT PRO，我们正在继续这一旅程，满足客户的特殊需求——通过简化、高效的工作流程和最新技术来支持实验室，优化他们的体验。通过不断扩展我们的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,

解决方案组合，生物梅里埃继续加强我们全面的抗菌药物耐药性（AMR）/抗菌药物管理（AMS）产品，并重申我们为全球医疗保健和实验室专业人员提供下一代身份识别/天体系统（ID/AST）的承诺，

'As a leader in the fight against AMR, bioMérieux continuously innovates by developing and renewing its key diagnostic solutions. VITEK

“作为抗击AMR的领导者，生物梅里埃通过开发和更新其关键诊断解决方案不断创新。VITEK

COMPACT PRO delivers fast, accurate and reproducible results comparable to VITEK

COMPACT PRO 提供快速、准确且可重复的结果，与 VITEK 相当。

2 and VITEK

2 和 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

2 COMPACT系统。符合人体工程学的特点、全新的直观用户界面以及更新后的软件，拥有最全面的知识数据库之一，使得VITEK

COMPACT PRO highly appealing to both clinical and industrial laboratories.'

COMPACT PRO对临床和工业实验室都非常有吸引力。

added Céline Roger-Dalbert, Executive Vice President, Research and Development.

新增了执行副总裁，研究与开发部门的塞琳·罗杰-达拉伯特。

COMPACT PRO will be used for routine identification of pathogens to ensure the quality and safety of food, pharmaceutical, and cosmetic products.

COMPACT PRO 将用于常规病原体鉴定，以确保食品、药品和化妆品的质量与安全。

ABOUT BIOMÉRIEUX'S COMPLETE ANTIMICROBIAL STEWARDSHIP (AMS) SOLUTION

关于BIOMÉRIEUX的完整抗菌药物管理（AMS）解决方案

bioMérieux's healthcare mission is to help sustain the use of antibiotic efficacy for generations to come.

bioMérieux的医疗使命是帮助维持抗生素的有效性，以造福后代。

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.

为了支持医院、机构和实验室开展其AMS计划，生物梅里埃提供了一套完整的解决方案，涵盖抗生素治疗的启动、优化和终止。这一不断发展的方案提供及时、准确的结果以调整治疗，将数据转化为可操作的见解，并通过灵活的合作方式无缝整合到任何医院中。

bioMérieux has more than 60 years of microbiology expertise with 75% of its R&D directed to research on antimicrobial resistance to ensure the current offer evolves to meet customers' AMS needs..

生物梅里埃拥有超过60年的微生物学专业经验，其75%的研发投入用于抗菌药物耐药性研究，以确保现有产品不断演进，满足客户对抗菌药物管理（AMS）的需求。

ABOUT BIOMÉRIEUX

关于生物梅里埃

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 €4 billion, with over 93% of sales outside of

自1963年以来，生物梅里埃一直致力于诊断领域，业务遍及45个国家，并通过庞大的经销商网络为160多个国家提供服务。2024年，公司收入达到40亿欧元，其中超过93%的销售额来自海外市场。