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Drug regulator takes stand on gene chip

By Sylvia Pagán Westphal

15 November 2003

THE first “gene chip” designed to predict how patients will respond to some drugs was launched in the US earlier this year with much fanfare. But the Food and Drug Administration has now asked its maker, Roche Diagnostics, to withdraw it pending formal evaluation.

The decision is likely to set a precedent for the red-hot field of pharmacogenomics: tailoring treatments to patients on the basis of their genetic make-up. Several companies are developing microarrays that detect genes or gene variants that determine whether a specific drug will work for an individual or whether they might suffer serious side effects. Some…

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