Browsing by Author "McMillin, Gwendolyn A."

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    Association of Cannabis Use With Nausea and Vomiting of Pregnancy
    (Wolters Kluwer, 2022) Metz, Torri D.; Allshouse, Amanda A.; McMillin, Gwendolyn A.; Silver, Robert M.; Smid, Marcela C.; Haas, David M.; Simhan, Hyagriv N.; Saade, George R.; Grobman, William A.; Parry, Samuel; Chung, Judith H.; Jarlenski, Marian P.; Obstetrics and Gynecology, School of Medicine
    Our objective was to evaluate whether cannabis use was associated with nausea and vomiting in early pregnancy. Participants from nuMoM2b (Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-to-Be) enrolled from October 2010 through September 2013 with a PUQE (Pregnancy-Unique Quantification of Emesis) questionnaire and an available stored urine sample from the first study visit (median gestational age 12 weeks) were included. Cannabis exposure was ascertained by urine immunoassay for 11-nor-9-carboxy-delta-9-tetrahydrocannabinol (THC-COOH); positive results were confirmed with liquid chromatography tandem mass spectrometry. The primary outcome was moderate-to-severe nausea by the PUQE score. Overall, 9,250 participants were included, and 5.8% (95% CI 5.4-6.3%) had detectable urine THC-COOH. In adjusted analyses, higher THC-COOH levels were associated with greater odds of moderate-to-severe nausea (20.7% in the group with THC-COOH detected vs 15.5% in the group with THC-COOH not detected, adjusted odds ratio 1.6, 95% CI 1.1-2.2 for a 500 ng/mg Cr THC-COOH increment).
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    Characterization of Reference Materials for Genetic Testing of CYP2D6 Alleles: A GeT-RM Collaborative Project
    (Elsevier, 2019-11) Gaedigk, Andrea; Turner, Amy; Everts, Robin E.; Scott, Stuart A.; Aggarwal, Praful; Broeckel, Ulrich; McMillin, Gwendolyn A.; Melis, Roberta; Boone, Erin C.; Pratt, Victoria M.; Kalman, Lisa V.; Medical and Molecular Genetics, School of Medicine
    Pharmacogenetic testing increasingly is available from clinical and research laboratories. However, only a limited number of quality control and other reference materials currently are available for the complex rearrangements and rare variants that occur in the CYP2D6 gene. To address this need, the Division of Laboratory Systems, CDC-based Genetic Testing Reference Material Coordination Program, in collaboration with members of the pharmacogenetic testing and research communities and the Coriell Cell Repositories (Camden, NJ), has characterized 179 DNA samples derived from Coriell cell lines. Testing included the recharacterization of 137 genomic DNAs that were genotyped in previous Genetic Testing Reference Material Coordination Program studies and 42 additional samples that had not been characterized previously. DNA samples were distributed to volunteer testing laboratories for genotyping using a variety of commercially available and laboratory-developed tests. These publicly available samples will support the quality-assurance and quality-control programs of clinical laboratories performing CYP2D6 testing.
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    Pharmacogenetic allele nomenclature: International workgroup recommendations for test result reporting
    (Wiley, 2016-02) Kalman, Lisa V.; Agúndez, José A.G.; Appell, Malin Lindqvist; Bell, Gillian C.; Boukouvala, Sotiria; Bruckner, Carsten; Bruford, Elspeth; Bruckner, Carsten; Caudle, Kelly; Coulthard, Sally; Daly, Ann K.; Del Tredici, Johan T.; Drozda, Katarzyna; Everts, Robin; Flockhart, David; Freimuth, Robert; Gaedigk, Andrea; Hachad, Houda; Hartshorne, Toinette; Ingelman-Sundberg, Magnus; Klein, Teri E.; Lauschke, Volker M.; Maglott, Donna R.; McLeod, Howard L.; McMillin, Gwendolyn A.; Meyer, Urs A.; Müller, Daniel J.; Nickerson, Deborah A.; Oetting, William S.; Pacanowski, Michael; Pratt, Victoria M.; Relling, Mary V.; Roberts, Ali; Rubinstein, Wendy S.; Sangkuhl, Katrin; Schwab, Matthias; Scott, Stuart A.; Sim, Sarah C.; Thirumaran, Ranjit K.; Toji, Lorraine H.; Tyndale, Rachel; van Schaik, Ron HN; Whirl-Carrillo, Michelle; Yeo, Kiang-Teck J.; Zanger, Ulrich M.; Department of Medical & Molecular Genetics, IU School of Medicine
    This manuscript provides nomenclature recommendations developed by an international workgroup to increase transparency and standardization of pharmacogenetic (PGx) result reporting. Presently, sequence variants identified by PGx tests are described using different nomenclature systems. In addition, PGx analysis may detect different sets of variants for each gene, which can affect interpretation of results. This practice has caused confusion and may thereby impede the adoption of clinical PGx testing. Standardization is critical to move PGx forward.