The China Food and Drug Administration (CFDA) has given clearance to Bruker Corp. (Billerica, MA, and Beijing, China; NASDAQ: BRKR) to market and sell its in vitro diagnostics (IVD) MALDI Biotyper system as a medical device for identifying microorganisms isolated from human specimens.
Starting from a culture, the IVD MALDI Biotyper allows for microbial identification in a few minutes without further incubation steps. The system features the company's microflex matrix-assisted laser desorption ionization time-of-flight (MALDI-TOF), mass spectrometry-based identification to enable analysis of species that are difficult to identify using other microbiology techniques. An increasing number of case reports describe the identification of microorganisms causing human infections, which previously have been isolated only from environmental sources. The company's extensive reference library covers more than 2300 microbial species of gram-negative and gram-positive bacteria as well as anaerobes and yeasts, and often enables the identifications of unexpected microorganisms.
The approval is expected to facilitate clinical microbiology in China. "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," said Dr. Lisong Shen, 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.
Fast species identification is important for helping to guide selection of therapeutic drug(s) because of the increasing threat by multiresistant bacteria causing severe infections. The system is available in most of Europe; in the Americas in Canada, Argentina, Colombia, Ecuador, and Mexico; and in the Asia/Pacific region in Japan, China, Hong Kong, Singapore, Taiwan, and Australia. In November 2013, the MALDI Biotyper CA System received clearance for a first claim by the U.S. FDA.