Toxicogenomics

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Toxicogenomics is a form of analysis by which the activity of a particular toxin or chemical substance on living tissue can be identified based upon a profiling of its known effects on genetic material. Once viable, the technique should serve for toxicology and toxin-determination a role analogous to DNA-testing in the forensic identification of individuals.

Toxicogenomics may also be of use as a preventative measure to predict adverse "side", i.e. toxic, effects, of pharmaceutical drugs on susceptible individuals. This involves using genomic techniques such as gene expression level profiling and single-nucleotide polymorphism analysis of the genetic variation of individuals.

Studies of those types are then correlated to adverse toxicological effects in clinical trials so that suitable diagnostic markers (measurable signs) for these adverse effects can be developed.

Using such methods, it would then theoretically possible to test an individual patient for his or her susceptibility to these adverse effects before administering a drug. Patients that would show the marker for an adverse effect would be switched to a different drug. While this approach is currently theoretical, it has great potential.

There are many well-publicized cases in which popular drugs such as Vioxx and fen-phen were pulled from the market because of toxic effects experienced by a small percentage of patients, with a cost of many billions of dollars to the companies responsible, and the loss of a helpful drug to individuals not at risk for the side effects. If an accurate test using toxicogenomic methods could be developed that successfully identified patients who are susceptible to these adverse effects, these drugs could be returned to market with very little risk.

Such would have the triple benefit of re-allowing the therapeutic use of a previously banned drug, preventing potentially life-threatening side effects, and restoring the majority of the lost market share of these drugs to the company that developed them.