FDA Approval Causes Concern

The FDA, (U.S. Food and Drug Administration) has empowered individuals by authorizing direct access to information about genetic health risks through tests provided by 23andMe, a personal genetics company. The company offers information about genetic mutations and DNA variations that have been shown to increase the risk of disease. Although the FDA approved the 23andMe genetics test for risk of late-onset Alzheimer’s disease, researchers and physicians warn that the relationship between Alzheimer’s and the APOE gene is “complex and not fully understood.” Alzheimer’s expert, Rudolph Tanzi of Harvard Medical School, said such tests should be accompanied by genetic counseling. A test for the presence of the e4 variant of the APOE gene is used for late-onset Alzheimer’s, however, the company, 23andMe, states that it does not describe a person’s overall risk to develop the condition. Director of the FDA’s Center for Devices and Radiological Health, Jeffrey Shuren, MD, cautioned against over-interpreting test results. He states, “But it is important that people understand that genetic risk is just one piece of the bigger puzzle. It does not mean they will or won’t ultimately develop a disease.” Research shows that a host of environmental, modifiable factors contribute to Alzheimer’s risk. Harvard genetics professor Robert Green, MD, said, however, that people requesting personal genetic information can handle risk reports well. The test becomes available this month and was made possible by a new FDA permit type, including what the agency called “special controls” to assure accuracy of the tests. The FDA will create an exemption that allows 23andMe to release additional tests without further regulatory procedures. http://sumo.ly/yola