Thursday, February 11, 2010

Personal Genetics - Code of Practice

This blog is about personal genetics and disease prevention - the EUROGENE eTEN project was set up and funded by the EU to establish the infrastructure to deliver personal genetics services via practitioner or direct to consumer.

The aim of the blog will be to report on progress of the project and comment on relevant research / developments in related areas. One of the tasks of the project was a review of the European regulatory framework - this has been completed and will be summarised in a later blog (the full review has also been submitted for publication.

The main finding is the absence of formal regulations in place now and the probability that this unclear situation will not change for some time. Meanwhile personal genetics services roar ahead, with prices falling and genome coverage increasing. Our opinion is that we should follow and promote the Industry Code of Practice proposed by the UK Human Genetics Commission (HGC). This code was developed by academics, regulators, industry members and medical stakeholders to cover all aspects including testing, marketing, customer support, quality of information. In the absence of formal regulation we welcome the code and feel very strongly that the customer (both the practitioner and the end-user) should be fully informed about all aspects of the genetic testing services and all information should be easily available online. The first thing that any potential user of a genetic test, is full disclosure and transparency and we also feel that all companies should protect both the industry and consumers by following the HGC guidelines

“Common Framework of Principles for direct-to-consumer genetic testing services”

Claims must be accurate (promotional and technical), evidence transparent
• Genetic variants tested must have been clinically validated
• Risk assessments must use accepted methods and be transparent
• Clarity on privacy and use of customer’s DNA
• Full and clear information for the customer to understand the test including accuracy and limitations
• Recommendations to purchase follow-on products (e.g. supplements) must be fully and transparently supported by scientific evidence
• For some tests professional genetic and medical help should be available if needed
• Tests should not be supplied DTC to adults unable to provide informed consent

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