Roche's AmpliChip CYP450 Test receives FDA clearance
First microarray-based diagnostic test for detection of genetic variations that can influence drug efficacy and adverse drug reactions
Two key genetic regions encoding the enzymes of the cytochrome P450 complex are the CYP2D6 and CYP2C19 genes. The multiple variations in the CYP2D6 gene can result in poor, intermediate, extensive ("normal"), or ultra-rapid metabolism of CYP2D6-dependent drugs from a variety of classes, including anti-depressants, anti-psychotics, anti-arrhythmics, beta-blockers, pain medications, anti-emetics, and some anti-cancer drugs. Variations in the CYP2C19 gene result in either normal or poor metabolism of CYP2C19-dependent drugs from a variety of classes, including anti-convulsants, proton pump inhibitors, benzodiazepines, and anti-malarials.
Poor metabolizers treated with drugs that are dependent on "normal" enzyme activity are at increased risk for excessive or prolonged levels of the drug in their blood (excessive or prolonged therapeutic effect or toxicity), while ultra-rapid metabolizers may not achieve sufficient therapeutic levels in their blood with standard dosing. In the case of pro-drugs (that is, drugs that require enzymatic action before they become the therapeutic compound in the body), the opposite phenomenon occurs. It is important to note that multiple drugs taken at the same time (concurrent medications) and many other environmental factors such as diet, gender, and overall health, can inhibit or induce Cytochrome P450 enzyme activity.
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