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Predicting the future of EU genetic testing regulation - opportunities and pitfalls

This article was originally published in Clinica

Executive Summary

How should genetic tests be regulated in the EU? What special provisions should there be given the potential far-reaching impact of a patient learning they have an incurable disease, for example? Should they be freely available on the Internet, and how can users be protected from advertising? Joanna Hook and Grant Strachan, associates in the regulatory department of law firm Bristows LLP, look at the current regulation of these tests and at how the EU is likely to become much more challenging for manufacturers with the future revision of its IVD requirements

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