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AMP issues CYP3A4 and CYP3A5 genotyping assay recommendations

The Association for Molecular Pathology published consensus recommendations to aid in designing and validating clinical CYP3A4 and CYP3A5 genotyping assays and promote standardization of testing across laboratories (Pratt VM, et al. J Mol Diagn. Published online July 5, 2023. doi:​10.1016/j.jmoldx.2023.06.008).

The CYP3A4 and CYP3A5 genotyping recommendations are a joint consensus recommendation of the AMP, CAP, Clinical Pharmacogenetics Implementation Consortium, Dutch Pharmacogenetics Working Group of the Royal Dutch Pharmacists Association, European Society for Pharmacogenomics and Personalized Therapy, and Pharmacogenomics Knowledgebase.

The AMP Pharmacogenetics Working Group has developed a series of guidelines to help standardize clinical testing for frequently used genotyping assays. The latest report builds on the earlier recommendations for clinical genotyping of TPMT and NUDT15, CYP2C19, CYP2C9, CYP2D6, and genes important for warfarin testing.

“The human cytochrome P450 family 3 subfamily A [CYP3A] serves an important role in the metabolic transformation of approximately 50 percent of marketed drugs, including fentanyl, midazolam, quetiapine, pac­litaxel, statins, and other immunosuppressants,” said Victoria M. Pratt, PhD, chair of the AMP PGx Working Group, director of scientific affairs for pharmacogenetics at Agena Bioscience, and adjunct professor of clinical pharmacology at Indiana University School of Medicine.

The article is at https://bit.ly/jmoldx-​070523.