What are the clinical applications for the Roche AmpliChip CYP450 test?
A. The AmpliChip is an FDA-cleared device marketed by Roche. The device is used to interrogate specific polymorphisms and gene duplications in a subset of the CYP450 superfamily of genes so important to drug metabolism, namely, CYP450 2D6 and 2C19. The device has specific allelic coverage: 27 allelic variations for CYP2D6 and three allelic variations for CYP2C19. Knowledge of specific genotypes is associated with predictable phenotypes that laboratorians may report to treating physicians to better manage patient symptoms through rational therapy choices. Thus, so-called extensive and (to a large extent) intermediate metabolizers are the types of individuals for whom “one size fits all” drugs were developed. Of course, “one size does not fit all,” and some drugs are not efficacious in some individuals while some drugs cause adverse reactions in other individuals. So-called poor metabolizers given drugs metabolized via pathways controlled by these genes will poorly metabolize such drugs,