Paving the Way for Personalized Medicine
FDA role in new era of medical product development. 21st century evidence based medicine. Clinicians have observed that patients with similar symptoms may have different illnesses. “Personalized Medicine” tailoring of medical treatment to the individual characteristics, needs and preferences of each individual. Clinicians to utilize this information as relevant and usefulness of an intervention in patient care.
Likelihood of an intervention to improve patient outcome. NCBI and NIH informs as “one size does not fit all”
Clinical Validity: Healthcare Utilization Better than Single Gene Phenotypes
Multiple gene analysis is practical vs single gene analysis - Predict and prevent multiple drug reaction. Multiple gene analysis will predict multiple drug dose efficacy.
ADR- Adverse Drug Reaction
2011 ADR in US hospitals for healthcare cost and utilization Project shared origin of ADR Psychotropic Agents: ADR Originated (4.2%) ____ stay and 35% were present at admission. Cardiovascular Drugs- 29.4% were present at admission. Common 90% ADR were present at admission. There are some developed during hospital stay.
Current Evidence of Clinical Utility
Current evidence of clinical utility justify for CYP450- heme protein- genetic polymorphism application. While human genome sequencing has allowed scientists to target gene analysis and assess to determine clinical management of an individual based on present or absence of gene variation
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