NEW YORK (GenomeWeb) – Bruker said this week that it plans to make additional regulatory submissions for its MALDI Biotyper microbiology platform in the middle of this year.
In support of these planned submission, the company has launched a multi-site clinical trial for the instrument for validation of it for identification of rare Gram-negative bacteria, aerobic Gram-positive bacteria, yeasts, and anaerobic microorganisms.
In November of last year, Bruker received US Food and Drug Administration 510(k) clearance for the MALDI Biotyper and an initial library of more than 100 species of aerobic Gram-negative bacteria.
With the clearance, the Biotyper joined its primary competitor, BioMérieux's Vitek MS system, which received 510(k) clearance in August. The Vitek MS has maintained an advantage over the Biotyper in terms of breadth of coverage, however. While the Biotyper has FDA-cleared libraries only for aerobic Gram-negative bacteria, the Vitek MS has cleared libraries covering Gram-negative bacteria, Gram-positive bacteria, yeast, and anaerobes.
The planned regulatory submissions would help Bruker pull even in this regard. Bruker had originally planned to make these submissions in the first quarter of 2014.
Both the Biotyper and Vitek MS platforms identify microbes by matching the protein profiles of sample organisms generated via MALDI mass spec to profiles contained in a proprietary database. Compared to traditional biochemical methods of microbe detection, MALDI-based systems can offer significant improvements in speed, price, and accuracy.