Journal
PERSONALIZED MEDICINE
Volume 15, Issue 3, Pages 189-197Publisher
FUTURE MEDICINE LTD
DOI: 10.2217/pme-2017-0094
Keywords
analytical validation; combinatorial pharmacogenomics; genetic testing; neuropsychiatric conditions; pharmacogenomics
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Funding
- Assurex Health, a Myriad company
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Aim: The aim of this study was to validate the analytical performance of a combinatorial pharmacogenomics test designed to aid in the appropriate medication selection for neuropsychiatric conditions. Materials & methods: Genomic DNA was isolated from buccal swabs. Twelve genes (65 variants/alleles) associated with psychotropic medication metabolism, side effects, and mechanisms of actions were evaluated by bead array, MALDI-TOF mass spectrometry, and/or capillary electrophoresis methods (GeneSight Psychotropic, Assurex Health, Inc.). Results: The combinatorial pharmacogenomics test has a dynamic range of 2.5-20 ng/mu l of input genomic DNA, with comparable performance for all assays included in the test. Both the precision and accuracy of the test were > 99.9%, with individual gene components between 99.4 and 100%. Conclusion: This study demonstrates that the combinatorial pharmacogenomics test is robust and reproducible, making it suitable for clinical use.
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