title: FDA's draft guidance on laboratory-developed tests increases clinical and economic risk to adoption of pharmacogenetic testing.
authors.affiliation: Department of Medicine, Division of Clinical Pharmacology, Indiana University School of Medicine, Indianapolis, IN, USA.
authors.forename: Kenneth D
authors.initials: KD
authors.lastname: Levy
authors.affiliation: Pharmacogenetics Laboratory, Department of Genetics and Molecular Medicine, Indiana University School of Medicine, Indiananpolis, IN, USA.
authors.forename: Victoria M
authors.initials: VM
authors.lastname: Pratt
authors.affiliation: Department of Medicine, Division of Clinical Pharmacology, Indiana University School of Medicine, Indianapolis, IN, USA.
authors.forename: Todd C
authors.initials: TC
authors.lastname: Skaar
authors.affiliation: Indiana University School of Medicine, Indianapolis, IN, USA.
authors.forename: Gail H
authors.initials: GH
authors.lastname: Vance
authors.affiliation: Department of Medicine, Division of Clinical Pharmacology, Indiana University School of Medicine, Indianapolis, IN, USA.|Indiana Institute for Personalized Medicine, Indianapolis, IN, USA.
authors.forename: David A
authors.initials: DA
authors.lastname: Flockhart
mesh_terms: D064790:Clinical Laboratory Services / Q000331:legislation & jurisprudence*; D019411:Clinical Laboratory Techniques / Q000191:economics / Q000592:standards*; D006801:Humans; D010597:Pharmacogenetics / Q000191:economics / Q000379:methods*; D012306:Risk; D014481:United States; D014486:United States Food and Drug Administration