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Bruker Preps for US Launch of MALDI Biotyper with Collaborations, Gains Distributor, Regulatory Nod in EU

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As it prepares to bring its MALDI Biotyper to the US market, Bruker Daltonics this week announced collaborations with various partners in the US for the clinical validation of the instrument's workflow for microorganism identification.

Separately, the firm announced this week that the workflow received the IVD-CE mark in Europe and said last week that it had reached an exclusive distribution agreement for the Biotyper with Francisco Soria Melguizo in Spain.

The Biotyper is a mass spectrometry-based platform for the identification and classification of microorganisms using protein fingerprints. The system was originally launched in early 2006 but has been available only in Europe. Last fall, Frank Laukien, chairman and CEO of Bruker, told ProteoMonitor of the company's plans to launch the platform in the US in mid-2009 [see PM 09/25/08]. Presently, the Biotyper workflow is only for research use outside of Europe.

In a statement this week, the company said that more than 40 Biotypers have been installed in labs throughout Europe. In the US, the Microbiology Service of the National Institutes of Health Clinical Center in Bethesda, Md., has used the platform to conduct studies for the identification of yeasts and bacteria. According to the firm, the tests have shown advantages in cost, speed, and accuracy compared to conventional biochemical testing and gene sequencing.

The collaboration with NIH is currently focused on expanding the proprietary MALDI Biotyper database for the identification of mycobacteria, nocardia, and filamentous yeasts. The database currently contains more than 3,000 strains covering about 2,000 well-characterized microbial species. Larger-scale clinical studies are also being conducted at two "major US medical school hospitals" Bruker said without further elaborating. Results from those studies are expected later this year.

The Biotyper workflow begins with a culture colony and identification is done by matching the measured protein fingerprint of the microorganism against the proprietary MALDI Biotyper database. An automatic identification can be achieved in minutes, Bruker said, adding that multiple colonies can be spotted on a single target, and about 30 to 60 identifications can be performed per hour.

Also this week, the company said that as a result of the IVD-CE mark it has received, it is ready to use the Biotyper to target clinical routine analysis markets such as non-fermenting gram-negative bacteria, enterobacteriaceae, other gram-negative bacteria, gram-positive bacteria, and yeasts.

The mark is given when a product is in accordance with the European Union In Vitro Directive 98/79/EC, which provides guidelines for the commercial availability of in vitro diagnostic medical devices.

Finally, regarding the distribution agreement with Francisco Soria Melguizo, a Bruker official said that the company is now increasing the visibility of the Biotyper throughout Europe. The Spanish firm provides products for microbial identification and antibiotics susceptibility testing. It will distribute the Biotyper to laboratories in clinical microbiology and veterinary medicine in Spain.

Terms of the deal were not disclosed.

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