18 May 2005
The UK public interest group GeneWatch, a not-for-profit organisation that monitors developments in genetic technologies, has warned of a major threat to public health if human gene tests are not strictly regulated (see The Guardian news article). They report that one major pharmaceutical company, Roche, has presented draft guidance to the US Food and Drug Administration (FDA) to cover how its new genetic testing business should be regulated. The guidance, now being considered by the FDA, includes a requirement for the analytical validity of the test in question to be demonstrated (that is, the ability of a test to accurately measure the property or characteristic it is intended to measure, such as the presence of a genetic variant) but there is no requirement for scientific or clinical data to support claims of a link between a gene and the risk of future illness.
GeneWatch notes that Roche would stand to profit enormously if the FDA adopted the guidance, as it would allow them (and other companies) to market medicines to healthy people identified by genetic tests as being