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EDITOR'S PAGE

This issue of IVD Technology explores some of the latest technological trends in assay development. In their article, authors Kevin Jones and Betsy Moran discuss solid phase methods for sample preparation, collection, and purification in relation to their utility for routine immunoassay testing. In addition, authors Neil Cook and Richard Steele examine in their article the advantages of applying native autoantigens in autoimmune diagnostics. As one of the most important segments in the IVD market, immunoassays have been continually evolving and challenging IVD manufacturers to develop better and more-advanced assay technologies and products.

Since the mid-1960s, immunoassays have greatly contributed to clinical laboratory medicine. Today, immunoassays of all kinds (e.g., automated, manual, enzyme immunoassays, bead arrays, microarrays) dominate the IVD market. They have become one of the primary and indispensable tools for diagnosing and monitoring a wide variety of diseases.

In 2005, according to Kalorama Information (New York City), the global imm­unoassay market generated $5.8 billion in total revenues. The vast majority of these revenues (87%) came from mature market segments in North America, Western Europe, and Japan. Emerging markets with stronger economies such as India, Latin America, and Taiwan also demonstrated positive growth and the potential for continued expansion in routine immunoassays and other more esoteric tests.

With the commoditization of routine immunoassays and contractions in lab testing, the number of such assays performed in the United States, Japan, and Western Europe has recently declined. However, new growth in immunoassays is being derived from autoimmune, cardiac, and tumor markers that play a significant role in disease diagnosis and monitoring. By 2010, the immunoassay market is expected to reach $8.1 billion with an annual growth rate of 7%.

A couple of notable trends will influence the future direction of the immuno­assay market. First, emerging assays will fuel most of the growth in this IVD segment. But with greater demands for tests with higher sensitivity and specificity, all immunoassays will have to show they can improve patient outcomes. For example, increased knowledge of disease physiology derived from molecular biology and genomic studies will enhance the position of analytes used in chronic conditions such as cardiovascular disease, autoimmune disorders, and diabetes. Immunoassays combined with DNA probe studies will have an important place in postgenomic laboratory medicine.

Second, pharmaceutical companies are moving toward developing more specialized, population-targeted drugs, instead of general treatment regimens. Immunoassays will serve as biomarkers to select drug targets and treatment populations, and assess the efficacy of the intervention. While this emerging field is developing slowly, it is expected to become mainstream in about 10 years.

Even though the IVD market is rapidly changing and moving into new areas, assay development will play an important role in contributing and shaping the future direction of IVDs.

Richard Park