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.
|Number of pages||10|
|Journal||Expert Review of Molecular Diagnostics|
|State||Published - 2006|
Bibliographical noteFunding Information:
Roche Molecular Systems, Inc. markets the AmpliChip CYP450 Test detecting the CYP2D6 and CYP2C19 gene variations. Roche Molecular Systems, Inc. supported four of Jose de Leon’s lectures, some equipment for his laboratory and an ongoing research-initiated grant. Jose de Leon has not received any consultant payments and has no other financial arrangements with Roche Molecular Systems, Inc. He has no stocks in Roche or Affymetrix. Additionally, in the past 2 years, Jose de Leon has been on the advisory board of Bristol-Myers Squibb; received researcher-initiated grants from Eli Lilly; and lectured supported by Eli Lilly (once) and by Bristol-Myers Squibb (once).
- Amplichip cyp450 test
- DNA microarray
ASJC Scopus subject areas
- Pathology and Forensic Medicine
- Molecular Medicine
- Molecular Biology