AmpliChip CYP450 test: personalized medicine has arrived in psychiatry.
The US FDA has granted market approval for the first pharmacogenetic test using a DNA microarray, the AmpliChip CYP450, which genotypes cytochrome P450 (CYP)2D6 and CYP2C19. The test uses software to predict phenotypes and tests for 27 CYP2D6 alleles, including the deletions and duplications, and three CYP2C19 alleles. Other DNA microarray platforms are being developed for CYP testing, but none have been completely developed or approved by the FDA to date. The differences between an implementation of pharmacogenetic tests centered on the individual and implementation using a public health approach are discussed. In this review, the major obstacles to the wide implementation of pharmacogenetic testing in the clinical environment are summarized.
de Leon
Jose
J
University of Kentucky, Mental Health Research Center at Eastern State Hospital, 627 West Fourth St., Lexington, KY 40508, USA. jdeleon@uky.edu
D000483:Alleles; D001189:Aryl Hydrocarbon Hydroxylases / Q000235:genetics; D065731:Cytochrome P-450 CYP2C19; D019389:Cytochrome P-450 CYP2D6 / Q000235:genetics; D003577:Cytochrome P-450 Enzyme System / Q000235:genetics*; D006801:Humans; D006899:Mixed Function Oxygenases / Q000235:genetics; D025202:Molecular Diagnostic Techniques; D020411:Oligonucleotide Array Sequence Analysis; D010548:Personal Health Services; D010597:Pharmacogenetics / Q000379:methods*; D011570:Psychiatry / Q000379:methods*; D012680:Sensitivity and Specificity; D014481:United States; D014486:United States Food and Drug Administration
D003577:Cytochrome P-450 Enzyme System; D006899:Mixed Function Oxygenases; D001189:Aryl Hydrocarbon Hydroxylases; C045793:CYP2C19 protein, human; D065731:Cytochrome P-450 CYP2C19; D019389:Cytochrome P-450 CYP2D6