bioMérieux receives FDA clearance for mass spectrometry ID system


With 1.3 million deaths worldwide annually, antimicrobial resistance (AMR) is a global health priority

In-vitro diagnostics specialist bioMérieux has announced its Vitek MS Prime system, a MALDI-TOF mass spectrometry identification device, has received 510(k) clearance from the FDA. The system for routine microbial identification in minutes is now commercially available in countries that recognise CE-marking and in the United States.

The compact benchtop system is designed to increase laboratory productivity for greater impact on patient care, the company claims.

Brian Armstrong, Senior VP, Clinical Operations, North America said: “With Vitek MS Prime, we provide our US 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 prioritisation of urgent samples and continuous “load and go” will be valued”.

The system also integrates with the company’s Vitek 2 device for antimicrobial susceptibility testing and its 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, COO, Clinical Operations. “In just 6 months the adoption rate of customers in Europe has been astounding. Extending access to the US 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.”

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