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FDA Clears bioMérieux's VITEK COMPACT PRO System to Combat Antimicrobial Resistance

• bioMérieux has received FDA 510(k) clearance for its VITEK COMPACT PRO system, designed to improve microorganism identification and antibiotic susceptibility testing in clinical and industrial laboratories.

• The new system features ergonomic design improvements and simplified workflow that reduce sample processing time while maintaining the accuracy and reliability of its predecessor, the VITEK 2 COMPACT.

• With antimicrobial resistance causing 1.3 million deaths annually, the VITEK COMPACT PRO aims to provide faster diagnostic results to optimize patient treatment and support antimicrobial stewardship programs worldwide.

bioMérieux, a global leader in in vitro diagnostics, has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its VITEK COMPACT PRO system, an innovative solution for microorganism identification (ID) and antibiotic susceptibility testing (AST). The system is designed to help clinical laboratories diagnose infectious diseases and combat antimicrobial resistance, while also supporting industrial laboratories in identifying contaminants to ensure consumer safety.
The FDA clearance comes at a critical time in the fight against antimicrobial resistance (AMR), which continues to pose significant global health challenges. According to recent data, approximately 11 million people worldwide die from sepsis annually, with 1.3 million of these deaths attributable to antibiotic-resistant bacteria. In the United States alone, sepsis accounts for 1.7 million cases and at least 350,000 deaths each year.

Advanced Technology for Improved Efficiency

The VITEK COMPACT PRO builds upon the globally recognized advantages of its predecessor, the VITEK 2 COMPACT, while incorporating the latest diagnostic technology. The new system features an ergonomically advanced design and simplified workflow that enhances user experience and improves overall laboratory efficiency.
Laboratory technicians will spend less time on sample loading and processing compared to previous systems, according to bioMérieux's proprietary data. The company claims the VITEK COMPACT PRO offers one of the most efficient workflows and fastest routine ID/AST results in the industry, providing microbiology expertise for accurate and confident diagnostic insights.
Jennifer Zinn, Executive Vice President of Clinical Operations at bioMérieux, emphasized the company's commitment to innovation: "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."

Targeting Small and Medium-Sized Laboratories

The VITEK COMPACT PRO is particularly suited for small and medium-sized laboratories, including those transitioning from manual workflows to automated systems. This strategic positioning addresses a significant market segment that can benefit from the efficiencies of automation without requiring the infrastructure of larger systems.
Céline Roger-Dalbert, Executive Vice President of Research and Development at bioMérieux, highlighted the system's technical advantages: "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."

Applications Beyond Healthcare

While the primary focus of the VITEK COMPACT PRO is on clinical applications, the system will also serve industrial sectors. It will be used for routine identification of pathogens to ensure the quality and safety of food, pharmaceutical, and cosmetic products, extending bioMérieux's impact beyond healthcare settings.

Supporting Antimicrobial Stewardship

The VITEK COMPACT PRO is part of bioMérieux's comprehensive Antimicrobial Stewardship (AMS) solution, which covers antibiotic therapy initiation, optimization, and discontinuation. The company has dedicated 75% of its R&D efforts to research on antimicrobial resistance, reflecting its commitment to preserving antibiotic efficacy for future generations.
By providing timely and accurate results, the VITEK COMPACT PRO enables clinicians to adjust therapy appropriately, potentially reducing unnecessary antibiotic use and helping combat the growing threat of antimicrobial resistance.

Global Rollout Plans

Following the FDA clearance, bioMérieux plans a phased commercial launch of the VITEK COMPACT PRO. The system will initially be available in select countries, with a global launch scheduled to begin in the second quarter of 2025.
The clearance of the VITEK COMPACT PRO represents another milestone in bioMérieux's 60-year history of microbiology expertise and reinforces the company's position as a leader in diagnostic solutions for infectious diseases and antimicrobial resistance management.
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