Diabetes: The liquid chromatography, immunoassay and electrophoresis-based methods which are currently used to screen and monitor for blood disorders are expensive, laborious and time-consuming. In 2009, the Expert Committeeof the International Diabetes Foundation recommended the use of the hemoglobin-based A1c (hbA1c) test as the “method of choice” for diagnosing and monitoring diabetes. In contrast to previous assays, it is expected that the new MALDI (Matrix-Assisted Laser Desorption Ionization) TOF-MS (time-of-flight mass spectrometry) based test for hbA1c and genetic hemoglobin variants designed for use on theMALDI Biotyper platform will provide advantages with regards to specificity, accuracy, speed of analysis and cost per analysis. These performance and cost advantages, coupled with the ease of use and speed of a MALDI-TOF assay, are anticipated to result in higher patient screening rates, which is especially important in the case of diabetes where early detection of at-risk subjects can lead to the prevention of disease onset. Complications of undiagnosed or poorly controlled diabetes include cardiovascular disease, chronic renal failure, retinal damage which can lead to blindness, several kinds of nerve damage, and micro-vascular damage.
Hemoglobin Variants: Some well-known genetic hemoglobin variants are responsible for diseases such as sickle-cell anemia, C disease, and a separate class of diseases known as thalassemias. Diabetes is also reflected in the blood by an increase in the level of glycated hemoglobin, which is measured in the hbA1c test. In general, individuals with inherited blood disorders are physiologically vulnerable and are at higher risk of infection, stroke, heart failure, liver and acute chest syndrome. Late diagnosis of diseases such as sickle-cell anemia can result in delay of treatment and irreversible damage to major organs, including increased risk of stroke or kidney damage.
The MALDI Biotyper platform is already in widespread clinical use with over 800 systems installed globally. Applications include clinical routine microbial identification, environmental and pharmaceutical analysis, taxonomical research, food and consumer product safety and quality control, as well as marine microbiology. The MALDI Biotyper is available in a research-use-only version, as well as in an IVD-CE version according to EU directive EC/98/79 in various European countries, and as a Class 1 Medical Device to clinical microbiology sites in Canada. In the United States of America the MALDI Biotyper is available for research use only, not for use in diagnostic procedures.
Dr. Gary Kruppa, Vice President for Business Development at Bruker Daltonics, stated: “The MALDI Biotyper is a versatile, robust, benchtop system that is well suited for use in clinical laboratories as evidenced by its large installed base. We are very pleased to be working with the world-class team of researchers at the UVic GBC Proteomics Centre on the development and validation of high throughput iMALDI tests to further broaden the clinical applications of the MALDI Biotyper platform.”
Professor Christoph Borchers, Director of the GBC UVic Proteomics Centre, commented: “The collaboration with Bruker is an excellent match. We believe that further development of our MALDI and immunoMALDI (iMALDI) technology will lead to commercialization of MALDI-TOF based tests for a number of important diseases. Developing and validating these tests in collaboration with Bruker gives us a partner ready to deploy such tests on the clinically accepted MALDI Biotyper platform, which will reduce our time to market.”