NEW YORK (GenomeWeb News) – Bruker said today that its Bruker Daltonics business has received EN ISO 13485 certification for the development, manufacturing, and distribution of its mass spectrometry systems for in vitro diagnostics use.
The firm called the certification, which is granted by the International Organization for Standardization and covers its manufacturing operations in Germany, an “important milestone” in its efforts to develop its diagnostics business. Bruker made the announcement from Barcelona, Spain, where the 18th European Congress of Clinical Microbiology and Infectious Disease kicks off tomorrow.
“Our ISO 13485 certification now allows us to further develop several of our clinical research platforms towards IVD-CE certification and reimbursement: our MALDI BioTyper mass spectrometry system is already being adopted in clinical microbiology, and we are also very excited about our MALDI Molecular Imager solution for molecular histology,” Wolfgang Pusch, assistant vice president of the Bruker Daltonics Clinical Research Systems business, said in a statement. “Moreover, many of our customers are accelerating their peptide and protein biomarker discovery and validation efforts, and we expect the emergence of future IVD multimarker panels for clinical proteomics.”
Bruker has been plotting a future in the in vitro and molecular diagnostics markets. Last month at the Pittcon 2008 meeting in New Orleans, Frank Laukien, chairman and CEO of Bruker, said during that the firm would provide more information on its plans for the molecular diagnostics market during the third quarter of 2008.