Increase in genetic tests highlights need for oversight

The availability of genetic and genomic tests is increasing at a rapid rate. One of the factors contributing to the explosion of available tests is the relative lack of regulatory oversight of genetic testing in the US. And when that happens, patients can be harmed. One of the areas of greatest expansion in genetic and genomic testing has been in the development of tests marketed directly to consumers. These tests, which can be ordered by individuals over the telephone or Internet without the involvement of a doctor, claim to provide genetic information about a wide range of medical and nonmedical issues. With any type of genetic or molecular testing, but especially with those marketed directly to consumers, there needs to be a level of regulatory oversight that ensures that the test does what it says it will do and predicts what it says it will predict.