FDA to regulate direct-to-consumer genetic tests.

began, genetic tests were available for about 100 diseases — most of them caused by just one faulty gene, such as the mutations that cause Tay-Sachs and cystic fi brosis. As genomic technologies matured and sequencing became less costly, companies began developing tests for a wider range of complex, multigenic, common diseases. These were initially offered by laboratories used by physicians, but more recently dozens of companies have begun marketing such tests on a DTC basis. The fi rst advertising campaign for a genetic test, Myriad Genetics’ BRACAnalysis, took place in the early 2000s. It included television ads for the test, which detects mutations in the BRCA1 and BRCA2 genes that raise the risk of breast and ovarian cancers. Myriad also advertised in the playbill of the Broadway play, Wit , which was about a professor dying of ovarian cancer. Audrey Chapman, Ph.D., professor of medical ethics and humanities at the University of Connecticut School of Medicine in Farmington, analyzed that campaign and concluded that it essentially marketed the BRCA1 and BRCA2 test to the general public, even though it is not an appropriate test for most of the population ( American Journal of Bioethics, June 2008). She said that many women who requested the test received results without any counseling or were given incorrect results by physicians without genetic expertise. By 2007, the number of genetic tests had increased to well over 1,000; hundreds of these were DTC tests for medical and health-related conditions ( see Statbite). In cancer, some tests are for high-penetrance FDA To Regulate Direct-to-Consumer Genetic Tests