Briefs

GenomeWeb writes about the role of microarray data in the drug-approval process.

If it lives up to its promise, increasingly powerful microarray technology could revolutionize toxicology testing and provide entirely new insights of drug mechanisms.

But when can the pharmaceutical industry start trusting the technology? When should it make the leap from investigative, experimental technique to industry standard? And should the FDA start using microarray data to make critical decisions about the safety and efficacy of new drugs?

Yes, say some drug developers, who point to the potentially invaluable knowledge that microarrays could provide.

No, say others, who fear that the uncertainty, sloppiness, and lack of reproducibility that still plague the chips will inadvertently kill off potentially valuable drugs.

Experts on both sides of the regulatory fence worry that gene arrays may generate too much misleading data that could accidentally sink a tender young drug.

Now that near-global chips make it possible to run tens of thousands of assays simultaneously, hundreds of false positives are almost guaranteed. Distinguishing real toxicity warnings from the false positives is no simple matter for either pharmaceutical researchers or FDA reviewers.

But if overcautious drug developers shy away from powerful gene chips completely, the pharmaceutical industry as a whole will be held back.

See full article at

http://www.genomeweb.com/articles/view.asp?Article=200241594143