Massachusetts-based manufacturer of scientific instruments, Bruker Corporation (BRKR), received clearance from the China Food and Drug Administration (:CFDA) for marketing and selling its In Vitro Diagnostics (:IVD) MALDI Biotyper System. This medical device will be available in China for the identification of microorganisms isolated from human specimens.
Following the news, Bruker's share price inched up 0.3% to eventually close at $24.18 yesterday.
To improve antibiotic stewardship, faster species identification is necessary so that the right therapeutic drugs can be timely prescribed to patients. According to reliable resources, the approval of this medical device will not only promote the development of clinical microbiology science in China, but will also help improve patient outcome and significantly reduce overall healthcare cost.
A Brief Note about MALDI Biotyper
Bruker's MALDI Biotyper family of systems enables molecular identification, and taxonomical classification of microorganisms, based on MALDI-TOF (matrix-assisted laser desorption ionization time-of-flight) mass spectrometer. Specifically, this system measures highly abundant protein found in all microorganisms, and have two versions, namely, research-use-only (:RUO) and IVD.
Compared to classical automated biochemical testing, the MALDI Biotyper-based microbial detection can provide faster time to result (:TTR) and better information with deeper and broader species coverage. With the help of this device, microorganisms can be detected in a few minutes, and do not require any further time-consuming incubation steps.
RUO MALDI Biotyper Version
The RUO MALDI Biotyper Version, known as the MALDI Biotyper CA System, includes the bench-top microflex MALDI-TOF mass spectrometer, software, IVD labeled reagents, a 48-spot MALDI target, and a library of microorganism reference spectra.
Bruker had conducted a multi-site clinical trial, where performance of the MALDI Biotyper CA System was compared to that of 16S ribosomal Ribonucleic Acid (RNA) gene sequencing. The overall accuracy of the MALDI Biotyper CA System was comparable to that of nucleic acid sequencing.
The MALDI Biotyper CA System received the U.S. Food & Drug Administration (:FDA) approval for a first claim in Nov 2013.
IVD MALDI Biotyper Version
The IVD MALDI Biotyper System includes the bench-top microflex MALDI-TOF mass spectrometer, automated analysis software, the IVD Bacterial Test Standard (:BTS), a 96-spot MALDI target and an extensive library of microorganism reference entries.
The extensive IVD MALDI Biotyper reference library now covers more than 2,300 microbial species of gram-negative bacteria, gram-positive bacteria, anaerobes and yeasts, and allows for the identification of unexpected microorganisms.