Bruker receives Health Canada approval for IVD MALDI Biotyper

At the 2011 Annual Meeting of the Canadian Association for Clinical Microbiology and Infectious Diseases (CACMID), the companies i2A Canada and Bruker Ltd. announced together that they have met the relevant Health Products and Food Branch (HPFB) of Health Canada regulations for the Bruker IVD MALDI Biotyper, and that this product is now available for sale as a Class 1 Medical Device to all clinical microbiology sites in Canada.

i2a Canada, as the exclusive sub-distributor of the Bruker IVD MALDI Biotyper for clinical microbiology in Canada since 2009, offers this robust, rapid and cost-effective method for bacterial identification. Optionally, the IVD MALDI Biotyper is also available in combination with the i2A SirWeb-MALDITOF software as a fully integrated solution for clinical microbiology laboratories.

The Bruker MALDI Biotyper is a MALDI-TOF mass spectrometry based bench-top platform for rapidly identifying bacteria and yeasts. Its carefully curated database includes quality-controlled entries of over 3,900 strains from over 2,000 well-characterized microbial species. Starting from a cultured colony, identification is performed by matching the measured protein fingerprint against the proprietary MALDI Biotyper database, followed by a final review by a trained microbiologist. Including the database search, identification can be performed in minutes. Multiple colonies can be spotted on a single target, and about 30-60 identifications can be performed every hour with no pre-testing required. The MALDI Biotyper offers considerably faster time-to-result (TTR), high specificity, very low false positive rates, low operational costs, and low technical barriers for new operators.

The MALDI Biotyper is available in a research-use-only version, as well as in the IVD MALDI Biotyper IVD-CE version according to EU directive EC/98/79 in certain European countries. Bruker has installed over 250 MALDI Biotyper systems worldwide in routine clinical and other laboratories for microbial identifications. Over 50 peer-reviewed papers have examined the capabilities of the MALDI Biotyper with excellent results reported to date. The Bruker MALDI Biotyper is rapidly becoming a new standard for robust, rapid microbial identification. Further applications are under development, including the research-use-only MALDI Sepsityper™ consumables kit for identification from blood cultures using the BD (Becton, Dickinson and Company) Bactec system and associated BD consumables. This rapid method for processing positive blood culture bottles is intended to reduce time to result for this critical specimen with results available in as little as 30 minutes.

Mr. George Goedesky, Bruker's Executive Director - MALDI Biotyper, stated: "We have been very encouraged by the excellent results seen in clinical evaluations on-going in Canada and the results generated have been very consistent to those seen in papers published to date. The Bruker IVD MALDI Biotyper offers clinical microbiologists an opportunity to reduce turn-around time, time-to-result and improve identification accuracy with an efficient, cost effective modern, molecular method. We are pleased to be partnering with i2A to bring this revolutionary technology to the clinical microbiology market in Canada."