Introduction Towards the end of 2000, as the USA was preparing for a new election year, President Clinton's health secretary, Dona Shallaly, received a thick report written by the 'Secretary's Advisory Committee on Genetic Testing' .1 This committee had been established three years before in order to assess the rapid development of genetic testing in the USA. One of the mandates of the committee was to evaluate risks associated with new forms of medical investigation. In a vein that echoed the postwar discourse in favour of increased government regulation of the drug market, the committee recommended the creation of a special Food and Drug Administration-based review procedure for surveying newly invented genetic tests (FDA). The basic idea was to create marketing authorisations whose delivery would depend on an evaluation of both the technical feasibility, and the medical utility of DNA testing. This proposal did not follow any sort of 'public health' disaster like the Thalidomide scandal, which triggered the 1962 reform on drug evaluation.2 It originated in the widespread suspicion that testing the genetic constitution of unborn or healthy individuals might be neither beneficial to the individual nor useful when viewed from a public health perspective. One specific medical innovation was at the very centre of the discussion that prepared the committee's task, namely the development of procedures for identifying chromosomal mutations predisposing women to early forms of breast cancer.