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Genetic Testing Services in Europe J. J. Cassiman Genetic testing services in is Professor in Human Genetics and Developmental Biology, Europe: Quality assurance and heads the Laboratory for Human Mutations and and policy issues Polymorphisms ± Center of Human Date received "in revised form): 12th October, 2001 Genetics at the University of Leuven. He is also coordinator of the EU "FP5) Jean-Jacques Cassiman, Alastair Kent, Glenn Miller, Peter Miny supported Thematic Network on Cystic and Erik Tambuyzer Fibrosis, and the RTD project CF-Pronet.His research mainly focuses on genetic testing, cystic ®brosis and Abstract The popular press is painting a picture of a future in which everyone has a tumour biology. detailed DNA pro®le of themselves drawn up.Such a vision of the future, however, is more science ®ction than science practice.Predictive tests for complex diseases and Alastair Kent cancer, eg colon cancer and breast cancer, are increasingly being used, and the related, is the Director of the and important, genetic counselling may become complex and comprehensive. Genetic Interest Group "GIG) Ð the UK alliance Quality assurance in genetic testing for both cytogenetics and molecular genetic of charities and support testing in Europe is also described.The quality of genetic testing in Europe could be groups for people affected by genetic substantially improved, and before a genetic test is accepted as a routine diagnostic or disorders.GIG's mission prognostic procedure it should have proven clinical utility.Pharmacogenetic testing is to promote the looks at the ef®cacy of medicines and their side effects on patients and patient groups, development of the scienti®c understanding and is increasingly being used to develop better targeted medicines. of genetics and the part Genetic testing services and genetic counselling are structured in different ways in that genetic factors Europe, and organisation and reimbursement differ among European countries. play in health and disease, and to see the Quality and non-directive genetic counselling must be made an integral part of quality speedy transfer of this genetic testing services, and be suf®ciently reimbursed.European networking and new knowledge into identi®cation of reference centres for quality-based diagnostic testing of genetic improved services and support for the diseases should be encouraged.Reimbursement within Europe for sample forwarding treatment of currently should be adapted to allow samples to be tested in countries other than the country of incurable conditions. Prior to joining GIG, origin of the patient. Alastair worked for a number of voluntary Keywords: genetic testing, quality assurance, counselling, pharmocogenetics, patients, society organisations on issues concerning policy, service development and disabled people. Introduction it is mapped and understood will allow such a deterministic vision of our future to The popular press is painting a picture of a materialise), the complexity of the future in which everyone has a detailed technology and the sophistication of Erik Tambuyzer Genzyme Corporate Affairs DNA pro®le of themselves drawn up, useful healthcare systems that would need to Europe, for disease prediction and treatment handle the sheer volume of information Interleuvenlaan 5, selection now and throughout their lives. generated for each of the 350 million citizens B-3001 Leuven, Belgium Quite apart from the scienti®c improbability of the European Union, put such a vision of Tel: 32 16 40 15 50 of this scenario it is extremely unlikely that the future ®rmly into the realm of science Fax: 32 16 40 03 91 genetic information no matter how carefully ®ction, not science practice. Henry Stewart Publications 1462-8732 "2001) Vol. 8, 2, 113±123 Journal of Commercial Biotechnology 113 Cassiman et al. Glenn A. Miller On the other hand, genetic testing has becoming available and only a limited is Associate Scienti®c been used since the 1960s for both prenatal number of diagnostic kits are commercially Director of Genetics and postnatal applications. Genetic tests can available, mainly for well-characterised Applications at Genzyme.His be performed on clinical samples diseases with well-studied mutations which laboratory carries out originating from a foetus prenatal testing), have been identi®ed years ago. In addition, genotype/phenotype on early embryos pre-implantation testing) many different DNA defects can be correlation studies for or on children and adults postnatal testing). responsible for the same or similar clinical internal therapeutic programmes, genetic Cytogenetic testing, ie chromosome analysis symptoms, and these defects may even have analysis for the on dividing cells from amniotic ¯uid or different regional frequencies in Europe. selection of appropriate other clinical samples, visualises This further complicates standardisation of protein replacement therapies as well as chromosome abnormalities such as procedures or kits. Diagnostic methods for contract research in trisomies ± three chromosomes of the same genetic testing are no longer used collaboration with type instead of two ± translocations or exclusively in genetic laboratories. The biotechnology and deletions. Cytogenetics is also being used in identi®cation of changes in DNA, RNA and pharmaceutical partners. the diagnosis or con®rmation of cancer and proteins relevant for the diagnosis and can be complemented by newer molecular therapy of somatic diseases, such as cancer cytogenetic techniques, including FISH and infections, has created a large number Peter Miny ¯uorescent in situ hybridisation) or CGH of additional applications of these is Associate Professor of comparative genome hybridisation) for methodologies in practically all medical Human Genetics at the University of Basel.He more subtle changes in the chromosome specialties. As a result, they have also is Vice Head of the structure or for studies on non-dividing become basic tools for most clinical Division of Medical cells. chemistry and clinical biology laboratories. Genetics at the Since the 1990s, molecular genetic testing, Another area that is growing rapidly is University Children's Hospital Basel and looking for deleterious changes in human pharmacogenetic testing. This technology responsible for the genes, has increasingly been used to detect tests the ef®cacy of medicines and their side cytogenetic laboratory gene defects. Such molecular testing studies effects on patients and patient groups, and and the prenatal diagnosis programme. changes in the composition or structure of is increasingly being used to develop better Dr Miny is also Medical DNA, RNA or even proteins using targeted medicines. The potential Director of Aristogen molecular techniques, such as polymerase consequences of pharmacogenetics on the GmbH, Ingelheim, chain reaction PCR), quantitative PCR, development of medicines from a research, Germany. mass spectrometry or sequencing. These clinical trial, regulatory process and methods are all different ways of detecting marketing point of view are staggering. Erik Tambuyzer changes in the composition of genetic is Genzyme material. Single gene disorders, caused by Corporation's Vice defects in a single gene resulting in the President, Corporate Clinical use, counselling, Affairs Europe, and a absence of a critical protein or the presence regulation for genetic testing and member of the of an abnormal protein, are being searched accessibility European Board of for and diagnosed with the help of such Genzyme.He started his techniques. Cystic ®brosis, for example, is a professional career at Before a genetic test is accepted as a routine Baxter Health Care, rather rare condition, but presents itself diagnostic or prognostic procedure it should followed by Innovi NV. through more than 900 mutations, most of have clear clinical utility, meaning that the He co-founded the them very rare, with a frequency of much test should help the medical staff in biotechnology company Innogenetics less than 0.1 per cent of all diagnosed cases diagnosing and treating or counselling a NV in 1985, of which he in the population. Many other so-called patient. Providing diagnostic or predictive remained General multifactorial disorders also have a genetic genetic testing is not just the provision of a Manager until 1992.In component, which may involve several test result to a doctor or a patient, but October 2000, Dr Tambuyzer was elected genes interacting with an individual's should also include, depending on the Chairman of the Board lifestyle or living environment. disease being looked at, the provision of of EuropaBio, of which Some of the methods used in genetic non-directive and professional genetic he is also the Founder testing have been or are being automated, counselling to the patient and sometimes and Chairman of the Ethics Committee. but many must still be performed manually. family members. For genetic testing, the Indeed, automation is only gradually decision to test and the evaluation of its 114 Journal of Commercial Biotechnology Henry Stewart Publications 1462-8732 "2001) Vol. 8, 2, 113±123 Genetic testing services in Europe results should always occur in the context of ESHG) is currently calling for this a genetic counselling session. recognition. Predictive tests for complex diseases and cancer, eg colon cancer, breast cancer, are increasingly being used, and the related counselling may become complex and Organisation and reimbursement comprehensive. The correct meaning and of genetic testing consequence of the test will have to be
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