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Candidate Gene Testing in Clinical Cohort Studies with Multiplexed Genotyping and Mass Spectrometry
Published on: June 21, 2018
Clinical and regulatory considerations in pharmacogenetic testing
Robert N Schuck1, Elizabeth Marek2, Hobart Rogers2
1Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD. robert.schuck@fda.hhs.gov.
Pharmacogenetic testing improves drug labeling, but clinical adoption varies. Factors beyond scientific evidence, like cost, influence the integration of genetic information into routine patient care.
Area of Science:
- Pharmacogenetics
- Regulatory Science
- Clinical Practice
Background:
- Pharmacogenetics reveals genetic influences on drug response variability.
- Regulatory bodies like the FDA incorporate pharmacogenetic data into drug labeling.
- Clinical practice decisions are influenced by scientific data and other factors.
Purpose of the Study:
- To review examples of pharmacogenetic testing information in drug labeling.
- To explore the impact of evidence, public health, and predictive utility on clinical uptake.
- To understand factors influencing the heterogeneity of pharmacogenetic test adoption.
Main Methods:
- Review of selected cases where pharmacogenetic testing was added to drug labels.
- Analysis of the scientific evidence supporting each pharmacogenetic biomarker.
- Assessment of potential public health impact and predictive utility.
Main Results:
- Pharmacogenetic information has been incorporated into labeling for new and existing drugs.
- Some pharmacogenetic tests have been readily adopted into clinical practice.
- Limited clinical uptake has been observed for many pharmacogenetic testing strategies.
Conclusions:
- Advances in pharmacogenetics are significant for understanding drug response.
- FDA actively includes pharmacogenetic information in drug labeling.
- Clinical uptake of pharmacogenetic testing is variable due to factors beyond scientific data.
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