Proposed amendments to draft European regulations governing the use of medical devices could see the use of genetic tests restricted to specific scenarios. Here Will Greenacre, Policy Officer at the Wellcome Trust, explains how medical research funders are getting together to raise concerns that the proposals could limit the availability of genetic testing — and hamper the burgeoning field of stratified medicine.
Genetic testing is becoming an increasingly vital part of mainstream healthcare. These types of tests, usually carried out on blood samples, are used to identify the presence or absence of particular genetic variants. The results are then analysed to diagnose a condition, determine susceptibility to developing a disease, or to inform a course of treatment.
For example, a doctor might refer a patient for genetic testing because their family history indicates an increased risk of heart disease. Genetic testing can identify raised susceptibility, and then inform conversations between doctor and patient about lifestyle changes and, if necessary, further treatment to reduce the risk.
Genetic tests are in the spotlight right now because the European Union is currently redrawing the rules governing the manufacture and sale of all medical devices, including in vitro diagnostic devices from blood glucose monitoring kits for diabetes and home pregnancy tests, right through to complex hospital assays. Read more