Making a new technology work: the standardization and regulation of microarrays

Abstract

The translation of laboratory innovations into clinical tools is dependent upon the development of regulatory arrangements designed to ensure that the new technology will be used reliably and consistently. A case study of a key post-genomic technology, gene chips or microarrays, exemplifies this claim. The number of microarray publications and patents has increased exponentially during the last decade and diagnostic microarray tests already are making their way into the clinic. Yet starting in the mid-1990s, scientific journals were overrun with criticism concerning the ambiguities involved in interpreting most of the assumptions of a microarray experiment. Questions concerning platform comparability and statistical calculations were and continue to be raised, in spite of the emergence by 2001 of an initial set of standards concerning several components of a microarray experiment. This article probes the history and ongoing efforts aimed at turning microarray experimentation into a viable, meaningful, and consensual technology by focusing on two related elements:1) The history of the development of the Microarray Gene Expression Data Society (MGED), a remarkable bottom-up initiative that brings together different kinds of specialists from academic, commercial, and hybrid settings to produce, maintain, and update microarray standards; and 2) The unusual mix of skills and expertise involved in the development and use of microarrays. The production, accumulation, storage, and mining of microarray data remain multi-skilled endeavors bridging together different types of scientists who embody a diversity of scientific traditions. Beyond standardization, the interfacing of these different skills has become a key issue for further development of the field.

Figure 1

Growth in the number of microarray publications, patents, and projects. Since the late 1990’s there has been a steep increase in productivity in all three domains.

Figure 2

Microarray standards co-authorship network. The map was produced using ReseauLu, a software package for heterogeneous network analysis (www.aguidel.com). We queried PubMed for microarray articles, using the subheading “standards” (1991-present). The size of the nodes is proportional to the number of articles co-authored. Only the top 150 authors are represented on the map, and each author is represented by a single node.