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Current in vivo and in vitro models can't keep up with the demand for the safety assessment of large numbers of compounds emerging from high-throughput strategies. Pharmaceutical companies and start-ups are therefore building new systems that they hope will be capable of predicting the toxicity liabilities of new compounds. Cheminformatics can help week out toxic compounds at the lead selection and optimization stage; toxicogenomics may provide a toxicity diagnostic capability at all stages of drug development. For both toxicology approaches, there is not yet enough high quality data to build predictive models. Toxicology-focused cheminformatics programs attempt to consolidate data from hitherto untapped sources; toxicogenomics companies are engaged in the fussy and expensive process of manufacturing data from scratch and validating them with biological experiments.
In an intriguing deal, GE Medical Systems, one of the largest suppliers of MRI and PET equipment, is teaming up with Genometrix, Inc., an applied genomics company in a research collaboration that will combine molecular imaging techniques with genetic probes to develop technologies for detecting and quantifying risk levels for diseases such as breast and prostate cancer.
Newly abundant genomic data is driving formation of all sorts of technology-based businesses. But markets for new tools are already chaotic and competitive, in part because customers know they've got many choices. Nanogen is in the thick of it. Pharmaceutical researchers weren't so interested in the firm's low-density gene chips, so the firm is now focusing on the clinical diagnostics market where managers believe flexible, accurate NanoChips will be better appreciated. The trouble is, the long-foretold market for molecular diagnostics still barely exists. On one hand, market immaturity spells opportunity for Nanogen as an early entrant, but it also means the company has to bushwhack a new path for its technology. It's not easy. For now, Nanogen is marketing its system to researchers in clinical diagnostic labs, university hospitals and government institutions-scientists at the cutting edge, who may become key content developers. The firm is also working to better serve drug makers. The company's customers display little loyalty yet: they're eager to try other new technologies too. Nanogen is betting that the superiority of its system will win hearts and minds as the market for molecular diagnostics takes shape.
There's growing conviction that gene arrays are less useful than first imagined for expression studies and diagnostics--and that directly reading protein expression will more likely provide an accurate picture of biological status-health, disease, and pharmaceutical response. Thus, a number of companies have started up to create, on the analogy of gene arrays, protein arrays, to allow the simultaneous and quantitative testing of large numbers of proteins-potentially thousands.But the task is easier said than done. First, there are too few proteins known to allow testing for worthwhile expression patterns; and, second, because of the delicacy and variety of proteins, surface chemistry and other problems have historically made arrays impractical. None of this daunts the start-ups who, opportunistic, are looking to exploit the markets they think they can get to first: clinical diagnostics and pharmaceutical clinical development programs.
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