title: Assessing the utility of genetic tests.
abstract: Genetic testing is a rapidly expanding area with many clinical applications. While the introduction of new genetic tests creates tremendous potential for improving patient care, it is essential to adequately evaluate these tests to ensure their accuracy and utility for clinical practice. This article describes a general approach to the evaluation of genetic tests and discusses common challenges that evaluators face. This article's goal was to provide a starting point for those who are concerned with the safety and utility of genetic tests to develop an overall strategy to perform the assessment.
authors.affiliation: ECRI Institute Health Technology Assessment Group and ECRI Institute Penn Medicine Evidence-Based Practice Center, Plymouth Meeting, Pennsylvania 19462, USA. fsun@ecri.org
authors.forename: Fang
authors.initials: F
authors.lastname: Sun
authors.forename: Karen M
authors.initials: KM
authors.lastname: Schoelles
authors.forename: Vivian H
authors.initials: VH
authors.lastname: Coates
mesh_terms: D019411:Clinical Laboratory Techniques; D005069:Evaluation Studies as Topic; D018734:Genes, erbB-2 / Q000235:genetics; D005820:Genetic Testing / Q000379:methods / Q000592:standards / Q000706:statistics & numerical data; D006801:Humans; D011933:Reagent Kits, Diagnostic; D014481:United States; D019564:Unnecessary Procedures
chemical_list: D011933:Reagent Kits, Diagnostic