We applaud FDA for establishing labeling requirements for ASR s. First, certain intended uses of genetic tests engender questions of safety and effectiveness that require a greater level of control. We will discuss each of these in turn. Intended uses of genetic tests Genetic tests can be used clinically to predict disease risks, identify carriers, diagnose disease, monitor progression of disease and response to therapy, and suggest the prognosis. The same genetic test can be used for more than one of these purposes.
Some tests provide information about acquired as well as inherited disease.
It is predictive uses of tests for inherited disorders that are of great concern to the Task Force. These tests raise complex psychosocial issues. Moreover, their clinical validity may be difficult to establish and their sensitivity and predictive value may not be high. Nor, in some instances, have the benefits they confer been proven. Consequently, test interpretation requires training and experience in human genetics and genetic counseling.