bioMérieux receives FDA 510(k) clearance for its VITEK® MS PRIME new MALDI-TOF mass spectrometry identification system

18 März, 2022

Marcy l’Etoile, France – March 18, 2022 — bioMérieux, a world leader in the field of in vitro diagnostics, announces that VITEK® MS PRIME, its new MALDI-TOF1 mass spectrometry identification system, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). This next generation system for routine microbial identification in minutes is now commercially available in countries that recognize CE-marking and in the United States.

With time-saving innovations to deliver faster identification results, VITEK® MS PRIME is a compact benchtop system designed to increase laboratory productivity for greater impact to patient care. VITEK® MS PRIME, manufactured by bioMérieux is a result of our constant commitment to support laboratories with tools that provide increased Antimicrobial Stewardship (AMS) efficiency and more effective patient therapy.

Brian Armstrong, Senior Vice President, Clinical Operations, North America emphasized: “With VITEK® MS PRIME, we provide our U.S. customers with an innovative system that brings greater lab workflow efficiency. Extensive lab input was incorporated into the development of VITEK® MS PRIME so we know the unique and differentiating features like prioritization of urgent samples and continuous “load and go” will be valued”. Labs will enormously benefit from the greatly reduced hands-on time2. This VITEK® MS PRIME system also integrates seamlessly with VITEK® 2 for antimicrobial susceptibility testing and MYLA® middleware for data integration and insights.

We are really pleased to bring this unique system to labs during the Covid-19 pandemic, when their need for optimal workflow and efficiency are greater than ever,” said Pierre Boulud, Chief Operating Officer, Clinical Operations. “In just 6 months the adoption rate of customers in Europe has been astounding. Extending access to the U.S. means even more labs can benefit from providing critical information more rapidly to clinicians so more effective antimicrobial therapy is prescribed sooner. Our goal is to empower labs to further improve patient management and play a key role in the fight against antimicrobial resistance.

With 1.3 million3 deaths worldwide annually, antimicrobial resistance (AMR) is a global health priority. Antimicrobial Stewardship (AMS), a key part of the arsenal to fight resistance, starts with diagnostics. VITEK® MS PRIME positively impacts stewardship programs by providing even faster, highly accurate pathogen identification making excellent use of the large database of clinically relevant species to support earlier, targeted therapy.

After receiving CE-marking in April 2021, the commercial launch of VITEK® MS PRIME is well underway as planned in many European, Asian and Latin American countries, extending now to the US and to the rest of the world throughout 2022.