The holy grail of medical analytical technologies is an instrument into which a clinician can put a drop of blood or saliva that quickly and accurately reports back any and all diseases a person may have. Although there have been major performance advancements in MALDI-TOF instrumentation in recent years, there is still significant need for improvement in clinical applications. Although clinical applications still account for a relatively small percentage of the overall MALDI-TOF market, the technology appears closer than ever to experiencing a major takeoff in demand in the area.

The potential benefit of MALDI-TOF MS in clinical diagnostics over other techniques is that it requires very little sample preparation, and can analyze a sample in as little as a few minutes. Current biochemical techniques can require hours per analysis. Furthermore, MALDI-TOF analyses can be highly automated, reducing the need for extensive training, as well as greatly reducing the potential for laboratory errors. But the biggest potential advantage of MALDI-TOF is its specificity, which means more definitive results, and therefore fewer additional tests, more cost-effective treatment, health care savings, and better survival rates.

MALDI-TOF performance, as well as that of other mass spectrometers, has continued to increase dramatically year after year. Top-performing MALDI MS instruments can offer accuracies of several ppm, sensitivity of several hundred attomoles and resolution on the order of 20,000 FWHM, although dynamic range continues to be an issue relative to LC/MS instruments. As good as the latest MALDI-TOF instruments are, even better performance is most likely needed to be able to more effectively sort through as many as the one million or more polypeptide species that are likely present in humans. Current state-of-the-art MALDI-TOF systems are useful for some clinical applications, and are being widely used for clinical and biomarker research in many areas. In 2005, Korea registered Bruker’s autoflex II MALDI-TOF systems as a class I medical device for in-vitro diagnostics (IVD) (see IBO 10/15/05). MALDI-TOF is also proving to be very useful in micro-organism and microbiological identification. In May, Bruker’s MALDI Biotyper workflow for microbial identification obtained the EU’s CE-IVD mark (see IBO 8/15/09).

The current market for clinical applications for MALDI-TOF MS is close to $30 million. Although growth has been modest, it appears to be gaining steam due to technological improvements, as well as money being funneled into cancer research and disease clinical research initiatives. Advanced tandem MALDI-TOF/TOF systems are more often used for the most complex matrices in biomarker research. Basic linear MALDI-TOF systems, which are used for more simple screening applications, are likely to be the most widely used for clinical diagnostics, and can cost as little as $100,000.

MALDI-TOF in Clinical

Applications at a Glance:

Leading Suppliers

• Life Technologies

• Bruker

• Shimadzu

Applications

• Microbiology

• Biomarker Identification

Instrument Cost

• $100,000–$800,000