The automated VITEK PRO platform will replace VITEK 2 and VITEK XL, with a US commercial launch planned for early 2027.
bioMérieux has received 510(k) clearance from the US Food and Drug Administration (FDA) and CE marking under the European Union’s In Vitro Diagnostic Regulation for VITEK PRO, a new system for microbial identification and antimicrobial susceptibility testing. The company says the instrument supports clinical laboratories in diagnosing infectious diseases and advancing antimicrobial stewardship efforts.
Using a single platform, laboratories can identify the microorganism responsible for an infection and determine its antimicrobial susceptibility, which helps clinicians select appropriate antibiotic therapy. bioMérieux says VITEK PRO builds on more than 35 years of expertise in identification and susceptibility testing technologies.
Designed for Medium- and High-Volume Labs
VITEK PRO offers a flexible capacity design that can expand to meet the current and future needs of medium- and high-volume laboratories. The company says the instrument is configured to help labs improve productivity in resource-constrained environments while maintaining confidence in diagnostic results.
The system combines workflow automation and digital capabilities with a broad antimicrobial testing menu that meets local epidemiology requirements.
The launch comes as antimicrobial resistance remains a major public health concern. The World Health Organization ranks it among the top global public health threats, and a 2022 analysis in The Lancet estimated that 1.27 million deaths in a single year were caused by it.
“With VITEK PRO, we are bringing together decades of expertise in automated microbiology with significant innovations in workflow, software architecture, connectivity, and user experience,” says Céline Roger-Dalbert, executive vice president, research and development, bioMérieux, in a release.
VITEK PRO follows the 2025 launch of VITEK COMPACT PRO and is the latest addition to the VITEK family.
“Today, with approximately 80% of our portfolio contributing to the fight against antimicrobial resistance, we remain committed to providing solutions that help drive better clinical decisions and improve patient outcomes,” says Jennifer Zinn, executive vice president, clinical operations, bioMérieux, in a release.
bioMérieux plans to begin the commercial launch in the first quarter of 2027 in selected geographies, including the United States and some European countries. Availability is then expected to expand progressively to other regions worldwide in the second quarter of 2027. The company says VITEK PRO will replace the VITEK 2 and VITEK XL systems.
