Clinical Validity and Utility

Some of the most important issues surrounding the introduction of a new genetic test concern its validity and clinical utility. Clinicians and patients will need to be confident that a test gives meaningful and useful data that helps guide prescription and treatment, in order to ensure that there is a clear benefit from treatment. However, there have been major problems involved in reproducing a number of important genetic association studies, which form the basis for claims about the genetics of drug response (17). Even where this evidence exists, it is not always clear how it should guide practice (25). A solid evidence base needs to be created in support of a test before it is widely used. At present, many national regulatory authorities do not require evidence of a genetic test's clinical validity or utility before marketing, as their main concern has been about quality assurance to ensure reliability. There is a strong case for improved regulatory oversight in order to ensure patients' benefit and maintain confidence in pharmacogenetic tests. This point has already been endorsed in relation to diagnostic genetic testing in general by the U.S. NIH Task Force on Genetic Testing (22).

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