title: Gene patents: perspectives from the clinical laboratory.
abstract: Patents involving human genes, human genetic material, and genotype-phenotype correlations are a reality and are increasingly having a negative effect on the clinical molecular diagnostic laboratory and on patient care. Specifically, gene patents and exclusive licensing of diagnostic testing has a detrimental effect on the quality of laboratory testing, the cost of testing, turnaround time, coordination of care, patient access to testing and the ability to confirm testing at a separate laboratory. In this article, gene patents are discussed from the perspective of a medical director of a molecular diagnostics laboratory, and the effect of such patents on clinical laboratory practice is examined.
authors.affiliation: Department of Pathology, Emory University School of Medicine, Atlanta, Georgia, USA. kmann@emory.edu
authors.forename: Karen P
authors.initials: KP
authors.lastname: Mann
mesh_terms: D019411:Clinical Laboratory Techniques / Q000191:economics; D003365:Costs and Cost Analysis; D005796:Genes; D006801:Humans; D007349:Insurance, Health, Reimbursement; D010330:Patents as Topic; D057089:Pathology, Molecular / Q000191:economics; D018802:Patient-Centered Care