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China Food and Drug Administration Clears IVD MALDI Biotyper as a Medical Device

July 7, 2014

Bruker reported that it has received clearance from the China Food and Drug Administration (CFDA) to market and sell its IVD MALDI Biotyper System as a medical device in China for the identification of microorganisms isolated from human specimens.

The company reported that that the IVD MALDI Biotyper, starting from a culture, allows for microbial identification in a few minutes without further time-consuming incubation steps.

According to a Bruker release, microbial identification is typically available one day earlier than with biochemical techniques. Additionally, MALDI-TOF mass spectrometry-based identification does not have the limitations of biochemical testing and can analyze species that have been difficult to identify by previous microbiology techniques.

The IVD MALDI Biotyper System includes the bench-top microflex MALDI-TOF (matrix-assisted laser desorption ionization time-of- flight) mass spectrometer, automated analysis software, the IVD Bacterial Test Standard (BTS), a 96-spot MALDI target and a library of microorganism reference entries.

Commenting on the CFDA clearance, Dr. Lisong Shen, the Director of Laboratory Medicine at Xin Hua Hospital affiliated with Shanghai Jiao Tong University School of Medicine, and President of the Shanghai Society of Laboratory Medicine, said: "The importance of MALDI-TOF mass spectrometry technology in the clinical microbiology field is widely recognized in mainland China now. The approval of Brukers IVD MALDI Biotyper system will further promote the development of clinical microbiology science in the country, not only in laboratory medicine, but also for infection control work within the hospitals. With the significant reduction of the time-to- result for identification of pathogenic bacteria, the patient outcomes will improve and the cost of care will be reduced significantly."

Dr. Wolfgang Pusch, Executive Vice President of the Microbiology Business at Bruker Daltonics, said: "The regulatory approval of the IVD MALDI Biotyper System in China is a major milestone and another achievement in our regulatory strategy to support the future growth of our business. We are committed to fully supporting our growing customer base in China. After the regulatory approval, we have immediately received positive feedback and have seen strong demand for the IVD MALDI Biotyper from the Chinese clinical microbiology market."

Bruker is a provider of scientific instruments and solutions for molecular and materials research, as well as for industrial, diagnostics and applied analysis.

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