Report on EU genetic testing services 28/11/03. By the Public Health Genetics Unit 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.

More than 700 000 genetic tests are performed every year in Europe, and the practice is expected to grow rapidly in the next few years. The report ('Towards quality assurance and harmonisation of genetic testing services in the EU') 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 regional 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.

Article courtesy of the Public Health Genetics Unit .