Pharmacogenomic Testing: Strategies and Technical Considerations for Clinical Laboratories.
* Context.--Clinical laboratories are increasingly implementing pharmacogenomic (PGx) testing. Although PGx is similar to genetic testing for other indications, there are unique aspects that laboratories should consider. Objective.--To aid clinical laboratories that are implementing clinical PGx tes...
| Publicado en: | Archives of Pathology & Laboratory Medicine Vol. 150; no. 5; pp. 339 - 354 |
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| Autores principales: | , , , , , , , , , , , , , |
| Formato: | tables/charts Journal Article |
| Publicado: |
College of American Pathologists
May2026
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=194029179&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 194029179 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 00039985 1FS jtl: Archives of Pathology & Laboratory Medicine issn: 00039985 maglogo: N pubinfo: dt: May2026 vid: 150 iid: 5 pid: 2550 pub: College of American Pathologists place: Northfield, Illinois artinfo: ui: 194029179 194029179 194029179 10.5858/arpa.2025-0179-CP 194029179 ppf: 339 ppct: 15 formats: fmt: @attributes: type: P tig: atl: Pharmacogenomic Testing: Strategies and Technical Considerations for Clinical Laboratories. aug: au: Ji, Yuan Brunk, Lindsey Bove, Betsy Danyal, Karamatullah Langman, Loralie J. Mot, Nicole Mroz, Pawel Natowicz, Marvin Reddi, Honey Shirts, Brian Smock, Kristi Wool, Geoffrey D. Zhang, Bing Melody Moyer, Ann M. affil: Division of Clinical Pathology, Department of Pathology, University of Utah and ARUP Laboratories, Salt Lake City sug: subj: Pharmacogenetics Clinical Laboratories Quality Improvement Program Implementation Genetic Screening Rules and Regulations Nomenclature Reference Values Alleles Translations Genotype Phenotype ab: * Context.--Clinical laboratories are increasingly implementing pharmacogenomic (PGx) testing. Although PGx is similar to genetic testing for other indications, there are unique aspects that laboratories should consider. Objective.--To aid clinical laboratories that are implementing clinical PGx testing by describing characteristics of PGx test design and validation, as well as approaches to reporting. Resources that are useful for clinical laboratories performing PGx testing will be highlighted. Design.--The College of American Pathologists formed a workgroup composed of laboratorians with expertise in clinical PGx testing. The workgroup included representatives from the Association for Molecular Pathology and the American College of Medical Genetics and Genomics. The workgroup reviewed pertinent literature, as well as experience from proficiency testing and from members' laboratories. Results.--The workgroup recommends that laboratories implementing PGx consider the following concepts: testing platform, test design (ie, selection of pharmacogenes and variants/alleles), use of reference materials during test development and as controls during clinical runs, star allele and standard nomenclature systems, translations from genotype to predicted phenotype, and considerations for result reporting including making medication recommendations. The workgroup provides considerations when using report vendors, emphasizing the clinical laboratory's role and responsibility when implementing such reporting tools from vendors. Conclusions.--Clinical laboratories should be familiar with the fundamentals of PGx, ensure that PGx testing meets the applicable regulatory requirements for all aspects of the clinical laboratory testing process, and follow recommendations for standardization of nomenclature and reporting. pubtype: Academic Journal doctype: tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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