Edited by Gary E. Marchant, Kenneth W. Abbott and Braden Allenby
Chapter 10: Innovative governance schemes for molecular diagnostics
Molecular diagnostics are expected to shepherd in a new paradigm in health care delivery known alternatively as personalized, individualized or precision medicine. The key distinction of this new approach is that health care decisions will be based on a patient’s individual molecular profile rather than on population or group characteristics or averages. Thus, for example, the selection and dose of a drug will be based on the particular set of variants present in the patient’s genome that affect drug metabolism. Diseases will be detected much earlier based on the presence or concentration of a protein biomarker in the patient’s blood, rather than waiting for the disease to manifest in clinical symptoms. The prognosis and best treatment option for a cancer patient will be determined by the changes in gene expression patterns in the patient’s tumor. These new molecular-based strategies for predicting, diagnosing, and treating disease are all dependent on sophisticated new molecular diagnostic tests. These molecular diagnostic tests will be the quarterbacks of the new personalized medicine paradigm. Just as a quarterback in football surveys the situation on the field, selects the appropriate play, and then sets that play in motion, molecular diagnostics will play a central role in assessing a patient’s health status and risks, selecting an appropriate intervention strategy, and then targeting the treatment based on the patient’s molecular profile.
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