Elucidating the genetic code
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These investigators concluded that the concept of therapy based on genotyping for CYP polymorphisms has not been assessed in prospective, randomized, controlled studies in which one group is dosed according to genotype while another group is dosed in a usual manner.It is unlikely that CYP2C9 genotyping will become routine practice unless its clinical value is supported by such rigorous assessments.Enzymes encoded by the P450 genes (eg, CYP2C9, CYP2C19, CYP2D6, CYP3A4, CYP3A5 etc.) are found primarily in the liver.The action of the P450 enzymes affects the blood levels of many drugs.The following is a list Diagnostic genotyping tests for some CYP enzymes are now available commercially.The Ampli Chip (Roche Diagnostics, Basel, Switzerland), cleared by the United States Food and Drug Administration (FDA) through the 510(k) process, is a microarray consisting of many DNA sequences complementary to 2 CYP genes applied in microscopic quantities at ordered locations on a solid surface (chip).
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Recent advances in molecular biology have improved the understanding of genetic factors underlying many ADRs.
The Ampli Chip was cleared for marketing for CYP2D6 testing in December 2004, and for CYP2C19 testing in January 2005.
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