Bruker Corporation recently announced it received FDA clearance for the MALDI Biotyper CA System. The MALDI Biotyper CA is a bench top mass spectrometry system used for the identification of Gram-negative bacteria cultured from human specimens. Previously, Bruker offered products in the MALDI Biotyper series for research-use-only although Bruker’s IVD-MALDI Biotyper has been available for use in clinical microbiology laboratories throughout Europe since receiving the CE mark of approval in 2009.
The results of a multi-site clinical trial showed the accuracy of the MALDI Biotyper CA to be comparable to 16S ribosomal RNA gene sequencing. With the FDA clearance for the MALDI Biotyper CA, Bruker is able to enter the US clinical microbiology market, offering some much needed competition for BioMerieux’s Vitek MS Clinical System which received FDA clearance in August of this year. The Vitek MS was the first mass spectrometry system to receive approval for automated yeast and bacterial identification in a clinical setting.
The chart below shows the activity MD Buyline has seen between these two systems within the last 12 months. BioMerieux’s Vitek MS System has seen 67% of the activity (*40% of which occurred after FDA approval in August) and Bruker’s MALDI Biotyper (research-use only) has seen 33% of the total activity. It will be interesting to see if this FDA approval will increase the activity for the MALDI Biotyper CA.