The AmpliChip: A Review of its Analytic and Clinical Validity and Clinical Utility

Background: In 2005, the FDA approved the Roche AmpliChip (TM) for clinical application. The AmpliChip is a microarray chip that has the capability to play an important role in clinical pharmacogenetics. Objective: Because of the possible influence the AmpliChip may have on patient medication management, the purpose of the review is to address the available evidence for the AmpliChip's overall performance at three key levels: analytic validity (genotyping accuracy, and prediction of the phenotype from the genotype) and clinical utility. Data Sources: We searched Medline, Embase and PubMed for studies of the AmpliChip. Limits were English language and 2005 (the year of FDA approval) and onwards, and we corresponded with authors for further papers of interest. Results: 17 articles provided data for analysis in this review: 4 involving genotype accuracy, 7 involving genotype to phenotype prediction and 9 involving clinical utility. Conclusion: There is limited literature comparing AmpliChip results to gold standard tests and test-retest reliability when assessing genotype accuracy. Also, there is limited literature on the accuracy of AmpliChip predictions of phenotypes from genotypes and minimal evidence with appropriately powered studies whether the AmpliChip genotype to phenotype predictions result in clinical benefit. At all three levels there is significant evidence that the AmpliChip has the potential to be a robust clinical tool. However, more and adequately powered studies are required to determine fully whether the AmpliChip is a clinically effective tool.