European Cancer Organisation


Genetic Risk Prediction Testing in Breast Cancer

Manifesto – Call to action

Please find below the draft of the ‘call to action' for this year’s European Breast Cancer Council (EBCC) manifesto, which will be presented at the special manifesto session on Friday 23 March at 13:00. The topic is the genetic testing of people for germline variants, particularly in the BRCA1/2 genes, and concerns about balancing benefit and harm as ‘direct to consumer’ testing becomes more widely available. As with the previous two manifestos, the call to action is supported by a fully referenced paper, which will also be available for comment.  

We welcome your contributions at this session and afterwards as we prepare the manifesto for publication:

Information about a person’s genetic make-up is providing crucial clinical information about risk, prevention and treatment in breast cancer and other diseases, and is a rapidly evolving field. Genetic tests that predict someone’s risk of getting breast cancer are now widely available not only in national health systems but also commercially, including on the internet, for low cost and frequently unregulated for quality and guidance. The results of such tests can be complex and misinterpreted if people do not have access to high-quality explanation and counselling, and can lead to pressure on health systems if testing increases (such as with the ‘Angelina Jolie’ effect in the US and elsewhere).    

It is important that genetic risk prediction in breast cancer is available to people and their doctors and the EBCC recognises that people have freedom to obtain the latest genetic tests if they are unavailable through national health systems. But tests must be of high quality and information must be interpreted by appropriate healthcare professionals to give people an accurate understanding; to inform evidence-based interventions; and to avoid possible harm, both physical and psychological, through unnecessary interventions and anxiety. Indeed, the European Parliament considered introducing a ban on all direct-to-consumer advertising of genetic tests in the forthcoming regulation on in vitro diagnostic medical devices, although this was not included in the final version.

We call on policymakers, health professionals and advocates in all European countries to:

  • Ensure genetic risk testing in national health services is carried out according to the latest evidence-based guidelines, with informed consent and access to clinical geneticists/genetic counsellors, and is available in breast cancer services
  • Act now to regulate commercial genetic testing products according to their safety and performance ahead of the impending EU In Vitro Diagnostic (IVD) Regulation 2017/746, and to protect against misleading advertising
  • Ensure that informed consent, counselling and medical supervision are provided for all genetic tests that have high-risk implications, as these measures will not be mandated by the EU IVD Regulation
  • Ensure information about genetic testing and breast cancer risk (including the potential drawbacks of using unregulated commercial tests) is given to people when they engage with health and social care systems, such as when women attend breast and cervical screening, and through public information campaigns
  • Inform health professionals such as primary care doctors about genetic testing and breast cancer risk and provide pathways to refer people to breast cancer services with specialists in clinical cancer genetics and genetic counsellors
  • Ensure patients diagnosed with breast cancer receive the current standard of care for genetic and genomic testing by a multidisciplinary team in a breast centre or unit, including access to clinical cancer genetic specialists.
  • Encourage healthcare providers and health professionals to participate in European networks and research programmes about all aspects of genetic and genomic testing, including clinical and psychosocial impacts.


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