A pharmacogenetic test kit produced by Swiss pharmaceutical firm Roche Diagnostics has received approval for sale as a diagnostic test within the European Union (see
press release). The AmpliChip CYP450 is the first DNA microarray or ‘gene chip’ based test to be approved for use in the EU. The device detects common polymorphisms in the
CYP2C19 and
CYP2D6 genes, which encode two key enzymes involved in the metabolism of many sorts of drugs including common anti-depressants, painkillers and beta-blockers. Certain common variants of these genes affect the rate at which drugs are metabolized by an individual and hence the response to the drugs. On the basis of the AmpliChip CYP450 results, individuals are classified as poor, intermediate, extensive, or ultra-rapid drug metabolisers, allowing doctors to select the most appropriate drug and dose for the patient’s genotype with respect to drug metabolism. Roche has hailed the new test as the dawn of the era of personalized medicine. However, the test costs around €450 and hence will not be accessible to all (see
Bionews report).