Bruker this week said it has received Health Canada approval to offer its proteomic-based IVD MALDI Biotyper for sale at all clinical microbiology sites in Canada.
The approval marks the first acceptance of the system for clinical use outside of Europe. At this year's JP Morgan Healthcare Conference in January, Bruker president and CEO Frank Laukien noted the company is currently preparing a submission to the US Food and Drug Administration for clearance of the device and is planning submission to Australian regulators as well (GWDN 01/13/2011).
The MALDI Biotyper is a MALDI-TOF mass spec-based system for identifying bacteria and yeast by matching their protein fingerprints against fingerprints in a proprietary database. According to the company, the platform can perform 30 to 60 identifications per hour.
The company will offer the device through i2a Canada, the exclusive sub-distributor of the IVD MALDI Biotyper for clinical microbiology in Canada. Since launching the system, which is also available in a research-only version, Bruker has installed more than 250 worldwide, it said in a statement.
The company also announced this week that it has closed its acquisition of liquid chromatography firm Michrom Bioresources (PM 01/25/2011). In a presentation at this year's Pittcon meeting in March, Laukien noted that the acquisition "is focused on proteomics initially" (PM 03/18/2011).
Bruker isn't "trying to become an LC company, but in LC/MS we want to have technology leadership," he added.
The company intends to invest in Michrom's proprietary CaptiveSpray ionization sources for LC-MS, its HPLC liquid chromatography systems, and related novel LC accessory, software, and consumables, it said in a statement.