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The Routine Clinical use of Pharmacogenetic Tests: What it Will Require?

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Abstract

Pharmacogenetic testing aims to personalize drug therapy with a view to optimising drug efficacy and minimise toxicity. However, despite the potential benefits, pharmacogenetic testing is mostly confined to specialised medical areas, laboratories and centres. Widespread integration into routine clinical practice has been limited by a complex set of issues including regulatory and reimbursement frameworks, evidence of clinical utility and clinician perspectives, practices and education. Here we assess the current barriers to widespread clinical uptake and identify the key issue necessary to address to accelerate routine testing.

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Abbreviations

ACCE:

Analytical validity, clinical validity, clinical utility and associated ethical, legal and social implications

ASCO:

American Society of Clinical Oncology

CPIC:

Clinical Pharmacogenetics Implementation Consortium

CYP:

Cytochrome P450

CYP2C9:

Cytochrome P450 2C9

EGAPP:

Evaluation of Genomic Applications in Practice and Prevention

EMA:

European Medicines Agency

FDA:

US Food and Drug Administration

HuGEnet:

Human Genome Epidemiology Network

mCRC:

Metastatic colorectal cancer

OPHG:

US Office of Public Health Genomics

RCT:

Randomized control trial

TPMT:

Thiopurine methyltransferase

UGT1A1:

UDP glucuronosyltransferase 1A1

VKORC1:

Vitamin K epoxide reductase complex subunit 1

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Authors and Affiliations

  1. School of Pharmacy and Medical Sciences, University of South Australia, Adelaide, Australia

    Mafalda M. Dias & Michael D. Wiese

  2. Department of Clinical Pharmacology, School of Medicine, Flinders University, Bedford Park, Australia

    Mafalda M. Dias, Michael J. Sorich & Andrew Rowland

  3. Flinders Centre for Innovation in Cancer, School of Medicine, Flinders University, GPO Box 2100, Adelaide, SA, 5001, Australia

    Michael J. Sorich, Andrew Rowland & Ross A. McKinnon

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  1. Mafalda M. Dias
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  2. Michael J. Sorich
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  3. Andrew Rowland
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  4. Michael D. Wiese
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  5. Ross A. McKinnon
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Correspondence to Ross A. McKinnon.

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Dias, M.M., Sorich, M.J., Rowland, A. et al. The Routine Clinical use of Pharmacogenetic Tests: What it Will Require?. Pharm Res 34, 1544–1550 (2017). https://doi.org/10.1007/s11095-017-2128-0

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