Misleading test results are further complicated by deceptive marketing and other questionable practices by the US Government Accountability Office

was presented (United States Government Accountability Office 2010). Although no concrete JPH203 molecular weight BIRB 796 price regulatory changes have taken place since these events, it has to be expected that regulatory oversight will increase in the near future. In Europe, the Human Genetics Commission of the UK presented in August its “framework of principles” on DTC genetic testing (Human Genetics Commission 2010). These principles were developed by a working group including representatives from the DTC genetic testing industry, clinical, and molecular geneticists, genetic counselors, experts in regulation, and those with experience in offering support to individuals with genetic conditions. The principles are mainly aimed at self-regulation of the DTC genetic testing market by promoting standards in the provision of genetic tests amongst commercial providers Selleck Volasertib at an international level. The principles have

been designed with the will to protect the interests of consumers and to allow the industry to grow. However, the principles have been criticized for being “weak and meaningless” by GeneWatch UK (GeneWatch 2010) and an editorial in the Lancet calls the guidelines insufficient and questions their practical value (The Lancet 2010). Furthermore, the Professional and Public Policy Committee of the European Society of Human Genetics had criticized the consultation document for focusing “too much on the

requirements the test providers should fulfill while paying too little attention to the quality of the genetic tests that are being sold” and remained “concerned about the quality of the tests provided” and believed “that the clinical validity (and not only the analytical validity) of genetic tests should be proven before one can even begin to tuclazepam consider selling such tests directly to consumers” (Professional and Public Policy Committee of the European Society of Human Genetics 2009). With this in mind, the European Society of Human Genetics endorsed in June 2010 a statement in which it recommended to ensure, among other issues, the quality of the testing services, the provision of pretest information and genetic counseling, a face to face consultation, and oversight of this industry. (European Society of Human Genetics 2010) As may be the case in the USA, stronger regulatory oversight may be forthcoming in Europe considering that the European Commission is in a process of revising the Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on In Vitro Diagnostic Medical Devices. A specific question addressed is the “need to create additional requirements or restrictions for direct-to-consumer genetic tests in order to ensure a better health protection” (European Commission. Health and Consumers Directorate-General. Consumer Affairs. Cosmetics and Medical Devices 2010).