Biotech company bioMérieux, a provider in the field of in vitro diagnostics, has received FDA 510(k) clearance for its MALDI-TOF mass spectrometry identification system, VITEK MS PRIME,

This next generation mass spectrometry system, which provides routine microbial identification in minutes, is now commercially available in countries that recognize CE-marking and in the United States.

The 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, comes from the company’s commitment to support laboratories with tools that provide increased Antimicrobial Stewardship (AMS) efficiency and more effective patient therapy. 

“With VITEK MS PRIME, we provide our U.S. customers with an innovative system that brings greater lab workflow efficiency,” says Brian Armstrong, senior vice president, Clinical Operations, North America. “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.’”

This VITEK MS PRIME mass spectrometry 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,” says 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 million 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. VITEKMS 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 VITEKMS 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.