16 May 2005
The Joint Research Centre (JRC), a European Commission body providing scientific and technical advice to support EU policies, has released a report on quality standards of genetic testing in Europe (Towards quality assurance and harmonisation of genetic testing services in the EU) on quality standards. The number of genetic tests performed yearly in Europe is in excess of 700,000 already, and the practice is expected to grow rapidly in the next few years. The report identifies an absence of unifying policy across Europe on quality, safety and efficacy of genetic testing services, as well as a lack of information on who is performing testing. Participation in EQA (European Quality Assurance) accreditation programmes is fragmentary.
It is proposed that an integrated network should be established throughout Europe (and potentially internationally) to administer an agreed quality assurance system for genetic testing and a central database of participating laboratories, to provide a consistently high performance standard. The authors envisage that this could incorporate existing national EQA schemes, where present, as there are certain advantages to national and region operations, such as the scope for reporting in native languages. The requirement for updated regulatory policies is discussed; current accreditation systems are voluntary. Formal schemes to evaluate the validity, clinical utility and cost-effectiveness of individual tests are proposed. The need for certified reference materials in genetic tests is identified as a key factor in maintaining quality of services, and the development of such materials is suggested. Counselling services offered in the context of genetic testing are highlighted by the report as being of particular importance, but the provision of such services is currently varied. One solution advanced is that laboratories should accept samples only from institutions that are able to provide counselling referrals.