The promise of MS revolutionizing the clinical diagnostics market has been discussed for years, but MS has only experienced limited commercial success in the market. MALDI-TOF is one of several MS techniques that is now making inroads into clinical diagnostics labs but is far from achieving its potential in the area. While technological hurdles are quite high for new entrants to the market, the regulatory environment has provided one of the biggest lifts to MALDI-TOF suppliers in the market.

The speed of MS-based clinical analyses is dramatically faster than most existing standardized tests, such as those based on immunoassays, while accuracy is generally better and the cost of consumables is lower. However, the capital costs of acquiring clinical diagnostic solutions that use MS and the expertise and training required to operate such systems are daunting for clinical labs. Overcoming these hurdles, as well as regulatory barriers, has greatly limited the rate of adoption of MS by clinical labs.

The respective strengths of various types of MS technologies make them amenable to certain types of clinical diagnostics applications. The characteristics of MALDI-TOF make it well suited to microbiological identification, which relies on resolving highly abundant proteins in complex biological samples. The first MALDI-TOF-based diagnostic solutions for clinical microbiology were commercialized in 2008 and 2009, led by Bruker’s Biotyper system. To date, all of the successful MS solutions in this area have been based on linear MALDI-TOF designs, which are relatively simple and inexpensive but provide the resolving power to reliably identify relevant proteins.

The total market for clinical diagnostics MALDI-TOF was still only about $15 million in 2012 but should experience very strong double-digit growth. Europe accounts for the largest regional percentage of demand, as both Bruker and bioMérieux are European-based companies that have offered CE-IVD marked MALDI-TOF solutions for several years now. BioMérieux’s VITEK MS system was codeveloped by Shimadzu and obtained CE-IVD status in 2011. These firms and others are currently working to achieve US FDA 510(k) approval, which has been an impediment to wider adoption of MALDI-TOF in American clinical labs.

However, some US-based contract testing labs, including Sequenom’s Center for Molecular Medicine, offer lab-developed tests under CLIA regulations that use MALDI-TOF. Although there have been major delays in US FDA approval processes, it seems to be only a matter of time before approval is achieved, which will lead to a major surge in sales. There is also potential for many more MALDI-TOF–based microbiological clinical diagnostic tests to be developed for other bacteria, yeasts, anaerobes and other fastidious microorganisms, which is likely to drive longer-term growth.

Suspension Array Systems at a Glance:

Leading Suppliers

• Bruker

• Sequenom

• bioMérieux

Largest Markets

• Microbiological Identification (Bacteria)

Instrument Cost

• $100,000–$350,000