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Put It on the Board, 3/18

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AMP issues recommendations for clinical CYP2C19 genotyping allele selection

To promote standardized testing across laboratories, the Association for Molecular Pathology published on Feb. 27 consensus, evidence-based recommendations for designing and validating clinical CYP2C19 assays.

The report, “Recommendations for clinical CYP2C19 genotyping allele selection: a report of the Association for Molecular Pathology,” was released online ahead of publication in the Journal of Molecular Diagnostics (doi:10.1016/j.jmoldx.2018.01.011).

Currently available CYP2C19 tests can produce variable results due to factors such as the choice of tested alleles, targeted testing of populations with varying ethnic backgrounds, and the technical performance of the various platforms. The AMP PGx Working Group was established to help standardize this process by recommending variants for inclusion in clinical CYP2C19 genotyping panels.

Victoria M. Pratt, PhD, associate professor of medical and molecular genetics at Indiana University School of Medicine and AMP PGx Working Group chair, said in a statement that the group started with CYP2C19 genotyping panels “due to the widespread adoption of these tests and our desire to help physicians, pharmacists, researchers, and other stakeholders better understand what these panels include and what the test results mean.”

The new report offers a two-tier categorization of CYP2C19 alleles as an aid for designing CYP2C19 genotyping assays. Using criteria such as allele function, population frequency, and availability of reference materials, the working group recommended a minimum set of alleles and their defining variants that should be included in all clinical CYP2C19 PGx tests (tier one). The team also defined a tier two list of optional CYP2C19 alleles that do not currently meet one or more of the criteria for inclusion in tier one. The recommendations are intended to facilitate testing and improve genotyping concordance across laboratories.

Karen E. Weck, MD, director of the medical genetics laboratory at the University of North Carolina School of Medicine and AMP PGx Working Group member, said a series of recommendations for PGx genes beyond CYP2C19 will be published.

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