BACKGROUND: CYP2C19 variants have been demonstrated to play an important role in determining response to clopidogrel and outcomes while on clopidogrel therapy. Predicting patient response through pre-therapeutic genotyping may therefore guide selection of antiplatelet therapy. METHODS: CYP2C19 genotypes were determined for 111 samples with the eSensor and compared with the Autogenomics expanded CYP2C19 panel, Luminex reagents, and bi-directional sequencing. Samples were obtained from the University of Chicago, ARUP Laboratories, and the Coriell repositories. Reproducibility studies were performed with 5 DNA samples with known CYP2C19 genotypes. RESULTS: Complete concordance was observed for all samples and all platforms. DNA concentrations as low as 0.05 ng/μl may be used on the eSensor platform. There was 100% reproducibility observed with 2.5% incidence of invalid tests. CONCLUSIONS: The eSensor CYP2C19 genotyping assay is accurate and compares well with 2 current commercial platforms. With a relatively rapid turn-around time of ~4 h and a high rate (97.5%) of valid tests, the eSensor can be translated into clinical use to identify slow and rapid metabolizers of clopidogrel who may benefit from alternate therapy or unconventional dosing of clopidogrel. An observed limitation of the eSensor is a maximum capacity of 24 tests/run.
BACKGROUND:CYP2C19 variants have been demonstrated to play an important role in determining response to clopidogrel and outcomes while on clopidogrel therapy. Predicting patient response through pre-therapeutic genotyping may therefore guide selection of antiplatelet therapy. METHODS:CYP2C19 genotypes were determined for 111 samples with the eSensor and compared with the Autogenomics expanded CYP2C19 panel, Luminex reagents, and bi-directional sequencing. Samples were obtained from the University of Chicago, ARUP Laboratories, and the Coriell repositories. Reproducibility studies were performed with 5 DNA samples with known CYP2C19 genotypes. RESULTS: Complete concordance was observed for all samples and all platforms. DNA concentrations as low as 0.05 ng/μl may be used on the eSensor platform. There was 100% reproducibility observed with 2.5% incidence of invalid tests. CONCLUSIONS: The eSensor CYP2C19 genotyping assay is accurate and compares well with 2 current commercial platforms. With a relatively rapid turn-around time of ~4 h and a high rate (97.5%) of valid tests, the eSensor can be translated into clinical use to identify slow and rapid metabolizers of clopidogrel who may benefit from alternate therapy or unconventional dosing of clopidogrel. An observed limitation of the eSensor is a maximum capacity of 24 tests/run.
Authors: Victoria M Pratt; Robin E Everts; Praful Aggarwal; Brittany N Beyer; Ulrich Broeckel; Ruth Epstein-Baak; Paul Hujsak; Ruth Kornreich; Jun Liao; Rachel Lorier; Stuart A Scott; Chingying Huang Smith; Lorraine H Toji; Amy Turner; Lisa V Kalman Journal: J Mol Diagn Date: 2015-11-24 Impact factor: 5.568
Authors: Nga Yeung Tang; Xun Pei; David George; Larry House; Keith Danahey; Elizabeth Lipschultz; Mark J Ratain; Peter H O'Donnell; Kiang-Teck J Yeo; Xander M R van Wijk Journal: J Appl Lab Med Date: 2021-11-01