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EELS (Ethical, Economic, Legal & Social) Article

The current clinical practice of pharmacogenetic testing in Europe: TPMT and HER2 as case studies

The Pharmacogenomics Journal volume 6, pages 3–7 (2006)Cite this article

The many expectations surrounding the clinical application of pharmacogenetics remain mostly unfulfilled.1, 2, 3 Only a limited number of applications have actually reached clinical practice.4 To gain insight into the reasons behind the low level of implementation of pharmacogenetic testing in the clinical world we have carried out a survey on the clinical practice of two pharmacogenetic tests in four different European healthcare systems (the United Kingdom, Ireland, Germany and The Netherlands). These were testing for Human Epidermal Growth Factor Receptor 2 (HER2)-overexpression and tests for determining Thiopurine Methyltransferase (TPMT)-activity.

HER2 was identified as a potential monoclonal-antibody target in the early 1980s thereafter the humanized IgG1 monoclonal antibody ‘trastuzumab’ entered clinical trials in 1992.5 In 1998 it was approved by the FDA as ‘Herceptin’, an anticancer therapy for use in breast cancer in patients who are HER2 positive. Commercial tests based on immunohistochemistry (IHC) testing and cytogenetic Fluorescent In-Situ Hybridization (FISH) testing have also been approved by the FDA for detection of HER2 overexpression. Herceptin was approved in Europe in the year 2000 by the EMEA's centralized procedure. The availability of commercial kits has coincided with or even preceded the launch of Herceptin in the countries studied. HER2 testing received a substantial boost when Roche, who market Herceptin in Europe, began to fund laboratories to provide HER2-testing services in large markets such as the UK and Germany. These services made HER2 testing available free of charge for physicians over a period of several years while the market for Herceptin became established.6

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Acknowledgements

We are extremely grateful to Sibylle Gaisser from ISI Fraunhofer (Germany), Christien Enzing from TNO-STB (The Netherlands) and Jim Ryan from CIRCA group (Ireland) and their colleagues for producing the mailing lists for the survey in their respective countries.

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Authors and Affiliations

  1. Institute for Prospective Technological Studies, European Commission -Joint Research Centre, Edificio EXPO, Seville, Spain

    A Woelderink, D Ibarreta & E Rodriguez-Cerezo

  2. SPRU-Science and Technology Policy Research, University of Sussex, Brighton, UK

    M M Hopkins

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  1. A Woelderink
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  2. D Ibarreta
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  4. E Rodriguez-Cerezo
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Correspondence to D Ibarreta.

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Woelderink, A., Ibarreta, D., Hopkins, M. et al. The current clinical practice of pharmacogenetic testing in Europe: TPMT and HER2 as case studies. Pharmacogenomics J 6, 3–7 (2006). https://doi.org/10.1038/sj.tpj.6500341

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