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- Genetic counseling appropriate to the type of test and disease should be offered;
and for some tests psychosocial evaluation and follow-up should be available. - Privacy and confi dentiality of sensitive genetic information should be secured
and the data safely guarded. - Special measures should be taken to avoid inappropriate testing of minors and
other legally incapacitated persons. - All claims regarding genetic tests should be transparent; advertisement should
be unbiased and marketing of genetic tests should be fair. - In biomedical research, health care and marketing, respect should be given to
relevant ethical principles, as well as international treaties and recommendations
regarding genetic testing - Nationally approved guidelines considering all the above-mentioned aspects
should be made and followed.
According to a survey, the majority of clinical geneticists in Europe are con-
cerned that DTC genetic tests are not clinically useful, and believe that sales of
certain types of DTC tests should be more closely regulated or banned (Borry and
Howard 2013 ). In their opinion, 90 % DTC tests for predictive disease risks based
on genes should require medical supervision. They are concerned that DTCs lack
clinical validity and utility. Of the 131 geneticists surveyed, 69 % felt that DTC
genetic tests for prenatal gender should be banned, 63 % wanted to ban DTC
genome scans, and 53 % believe that preconception disease carrier tests also should
be banned. However, only 27 % wanted to ban DTC ancestry testing. The authors
of the study concluded that better regulation is needed at the level of market intro-
duction of DTC genetic tests and a procedure should be developed similar to that for
pharmaceuticals.
References
Borry P, Howard HC. Survey of European clinical geneticists on awareness, experiences and atti-
tudes towards direct-to-consumer genetic testing. Genome Med. 2013;5:45.
European Society of Human Genetics. Statement of the ESHG on direct-to-consumer genetic test-
ing for health-related purposes. Eur J Hum Genet. 2010;18:1271–3.
Evans JP, Dale DC, Fomous C. Preparing for a consumer-driven genomic age. NEJM.
2010;363:1099–103.
McBride CM, Alford SH, Reid RJ, et al. Characteristics of users of online personalized genomic
risk assessments: implications for physician-patient interactions. Genet Med. 2009;11:582–7.
Prainsack B, Reardon J, Hindmarsh R, et al. Personal genomes: misdirected precaution. Nature.
2008;456:34–5.
Zonno K, Terry SF. Registry of genetic tests: a critical stepping stone to improving the genetic
testing system. Genet Test Mol Biomarkers. 2009;13:153–4.
22 Regulatory Aspects of Personalized Medicine