ABSTRACT

Most medical treatments are designed for the “average patient” as a one-size-fits-all-approach, which may be successful for some patients but not for others. Precision medicine, sometimes known as “personalized medicine” is an innovative approach to tailoring disease prevention and treatment that takes into account differences in people’s genes, environments, and lifestyles. Patients, physicians and researchers can use the Next Generation Sequencing tests to find genetic variants that help them diagnose, treat, and understand more about human disease. Researchers submit data to these databases, which collect, organize, and publicly document the evidence supporting links between a human genetic variant and a disease or condition. To learn which patients would benefit from a particular drug therapy or, conversely, which patients should not receive the medication, the Food and Drug Administration works with drug and device manufacturers that are developing certain tests called companion diagnostics.