References

the medical benefit of such services remains undocumented, the successful entry of several services and the growth of online commercial genomic services indicates interest among health-conscious citizens for understanding inherited disease risk. Another noteworthy factor that will probably play an important role in the next decade of clinical biomarker adoption is the development of standards and interoperability specifications for the health care delivery system and consumers. Interoperable health record environments will probably provide more flexibility and mobility of laboratory information and provide advantages to consumer empowerment in prevention and disease management.

One of the most important and sweeping challenges with biomarkers is the development of intellectual property policies that will bring opportunity and entrepreneurship in balance with meeting unmet market needs and clinical value. Because of the likelihood that single gene mutations or simple protein assays are not by themselves a discovery equivalent to diagnostic tests or new clinical markers, the arraying of the convergence of circles of technologies and knowledge will need new approaches to management for the combined aspects of technology to be brokered as real value in health care. Indeed, the challenges ahead in noting the importance overall for this notion is underscored more globally by Alan Greenspan in noting that "arguably, the single most important economic decision our lawmakers and courts will face in the next twenty- five years is to clarify the rules of intellectual property" [37].

Overall, a decade's worth of work has charted a robust and vibrant course for biomarkers across the biomedical research and development landscape. Clinical applications of biomarkers in medical practice are coming more into focus through diagnostics and molecularly targeted therapies, but a long period of time may pass before biomarker-based medicine becomes a standard in all areas of health care practice.

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