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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
KeywordsAcute Myeloid Leukemia Proficiency Testing Turnaround Time Gene Patent Clinical Laboratory Improvement Amendment
No sources of funding were used to assist in the preparation of this article. The author has no conflicts of interest that are directly relevant to the content of this article.
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