The term "clinical proteomics" is much in vogue these days. Conferences are held to discuss its promise, headlines in trade publications announce the "imminent arrival" of the technology and a host of market research reports attempt to predict the future size of this nascent market. But what exactly is "clinical proteomics?" BioInformatics, LLC set out to explore this issue knowing that while two-dimensional gel electrophoresis (2D PAGE) is a commonly used technique for protein analysis, newer and faster methods such as protein arrays would need to be used in a clinical environment. What survey research uncovered is that not only are relatively few researchers employing protein arrays in their disease studies, this select few are not yet able to clearly articulate their needs in terms of signal intensity, variation and detection. And while a majority of those currently using traditional 2D PAGE and mass spectroscopy plan to move to microarrays in the next 12 months, they are already aware of the challenges posed by inadequate reference databases and the difficulty of obtaining clinical samples. Early markets are comprised of innovators and visionaries-often they are influential researchers with reputations for innovation and for pushing existing technologies to their limits. Their work tends to play an important role in shaping the product expectations of the "early adopters" who will follow them, but they themselves readily admit their requirements are not yet truly understood. Such is the case with the tools and techniques of clinical proteomics. For suppliers hoping to dominate this technology, which could profoundly change some segments of clinical testing market, understanding the current experiences of visionaries and monitoring how their needs change over time is critical. Clinical Proteomics: A First-Glance Report confirms that the effectiveness of clinical proteomics will hinge on two technological components: rapid, multiplex protein detection assays and data analysis systems to assimilate vast amounts of protein expression data from healthy and diseased individuals into clinically relevant data sets. Based on a detailed survey of proteomic researchers, this First-Glance Report identifies the research objectives, methodologies, assay parameters and technological limitations that are currently associated with disease-based protein-profiling studies. In addition, these visionaries provide their thoughts on the disease applications, assay formats and technical standards for future protein-profiling assays that will be used for disease prognosis or diagnosis in a clinical setting. For suppliers of products for protein-profiling research, as well as for companies that need to stay abreast of the latest developments in clinical testing, this report provides a wealth of information about the present state and future directions of clinical proteomics. |
