3 February 2009
The report's authors state that although there is a strong licensing and quality assurance programme in place in this region, this has not kept up with the rapid pace in the development and availability of predictive genetic tests. In addition, there are no effective mechanisms to evaluate the clinical and analytical validity, clinical utility and cost-effectiveness of new tests. In order to combat this gap, the Task Force recommends the implementation of an oversight body which will be responsible for a test approval process following evaluation of the evidence base. They also recommend implementation of a mandatory approval process for each genetic test performed by laboratories and a process by which patients and providers can be educated about the tests. The Task Force warns that “Not addressing these issues will result in insufficient infrastructure to meet growing demands and an inability to implement and fund new tests.”
Although these recommendations have been made with the view of improving genetic testing services in the field of cancer, they also apply to many other fields of medicine. The system suggested by the Task Force is very similar to that in place in the UK. Here, the UK Genetic Testing Network functions as an oversight body that evaluates new tests for inherited disorders and acts as an advisory body to the NHS. It works with laboratories, commissioners, clinical genetic teams and patient support groups. However, many new biomedical tools and interventions are emerging, and the PHG Foundation considers the evaluation of such tools to be of importance. Our work stream on the Evaluation and regulation of genetic tests is focused on working with national and international bodies to achieve appropriate levels of assessment and oversight for genetic tests and biomarkers.