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
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Notes
Although purified nucleic acid could be prepared centrally and aliquots could be sent to multiple laboratories, this practice is discouraged by reference laboratories.
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Mann, K.P. Gene Patents. Mol Diag Ther 14, 137–140 (2010). https://doi.org/10.1007/BF03256365
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DOI: https://doi.org/10.1007/BF03256365