	Results Contain Health-related Predictions That Are Both Medically Unproven and Meaningless

Although there are numerous disclaimers indicating that the tests we  purchased do not diagnose disease, the 14 results we received predicted  that our fictitious consumers were at risk of developing a myriad of  medical conditions. With regard to the tests we purchased from Web site 1, the 3 results we  received stated that the DNA sample from the female displayed an  “increased risk of reduced calcium and Vitamin D absorption,” meaning  that she “may be at increased risk of developing osteoporosis.” Results  from the same tests contained similar predictions with regard to risks for  developing high blood pressure, type 2 diabetes, and heart disease. Furthermore, the genetic experts we spoke with informed us that even  though it is possible to make a definitive diagnosis of disease by looking at  certain genes, none of the predictions contained in any of the results we  received can be medically proven at this time. Medical Predictions Are Also Meaningless

Even if the predictions could be medically proven, the way the results are  presented—using ambiguous language—renders them meaningless. In fact, these types  of predictions could apply to any human that submitted DNA. Results Encourage the Purchase of Supplements That Are Overpriced, Make Unproven Medical Claims, and May Even Be Harmful

Results from the tests that we purchased from Web sites 1 and 4 further  mislead the consumer by recommending expensive supplements. Supplements Recommended by the Tests Purchased from Web Site 1

The results from the tests we purchased from Web site 1 recommended a  90-day supply of a “personalized, custom” nutritional formula for $295, or  approximately $1,200 per year. According to the product information, this  formula is based on “what your genetic profile reveals as areas in your  body that may need special support.” Despite this claim, when we  examined the listed ingredients, we found that we were recommended the  same product for all 3 of the fictitious consumers we created for this  test—2 of these consumers actually had the DNA from the female, 1 had  the DNA from the male, and all 3 had different lifestyle descriptions, as  previously shown in figure 1. Moreover, the experts we spoke with confirmed that the supplements  themselves are not unique; they contain vitamins that can be found in any  pharmacy or grocery store. According to the results, these supplements are personalized based on the  DNA submitted and lifestyle descriptions provided on the questionnaires,  and they are supposed to help “compensate” for “genetic deficiencies.”  Specifically, the product information accompanying the test results claims  that the regimen will repair damaged DNA through the consumption of 7  pills per day, including    4 tablets per day of a supplement containing over “70 vitamins,  minerals, and enzymes combined with “CAEs”, a proprietary extract  from the Tropical Rainforest botanical Uncaria tomentosa, known as  Cat’s Claw, which has been clinically shown to promote DNA repair in  the body.” A 60-day supply costs $160. Results Do Not Provide Recommendations Based on a Unique Genetic Profile

Results from the tests that we purchased from Web sites 1, 2, and 3  promise recommendations based on the consumer’s unique genetic  profile. If the  recommendations were truly based on the consumer’s unique genetic  profile, then these 9 consumers should have received the same  recommendations because their DNA came from the same source. Instead,  they received a variety of different recommendations, depending on the  fictitious lifestyles we provided for them. For example, when we said that  a fictitious consumer with the female DNA smoked and ate a lot of fatty  foods, we received recommendations to stop smoking and eat fewer fatty  foods. Although these recommendations  may be beneficial to consumers in that they constitute common sense  health and dietary guidance, DNA analysis is not needed to generate this  advice. Nutrigentic Testing in the United Kingdom: The company that  manufactures the tests used by Web sites 1, 2, and 3 used to sell the same  type of test in the United Kingdom—consumers provided DNA samples  and filled out a lifestyle questionnaire, and the company provided advice  on what consumers should do to improve their health with diet and  lifestyle changes. However, as demand for these new tests  continues to rise, it will become increasingly important for consumers to  have reliable information in order to determine which tests are accurate  and useful.
Why GAO Did This Study

Scientists increasingly believe that most, if not all, diseases have a genetic component. Consequently, genetic testing is becoming an integral part of health care with great potential for future test development and use. Some genetic tests are sold directly to the consumer via the Internet or retail stores, and purport to use genetic information to deliver personalized nutrition and lifestyle guidance. These tests require consumers to self-collect a sample of genetic material, usually from a cheek swab, and then forward the sample to a laboratory for analysis. Companies that market this type of test claim to provide consumers with the information needed to tailor their diet and exercise programs to address their genetically determined health risks. GAO was asked to investigate the "legitimacy" of these claims. This testimony reflects the findings of GAO's investigation of a nonrepresentative selection of genetic tests. Specifically, GAO purchased tests from four Web sites and created "fictitious consumers" by submitting for analysis 12 DNA samples from a female and 2 samples from an unrelated male, and describing this DNA as coming from adults of various ages, weights, and lifestyle descriptions. GAO also consulted with experts in genetics and nutrition.

What GAO Found

The results from all the tests GAO purchased mislead consumers by making predictions that are medically unproven and so ambiguous that they do not provide meaningful information to consumers. Although there are numerous disclaimers indicating that the tests are not intended to diagnose disease, all 14 results predict that the fictitious consumers are at risk for developing a range of conditions, as shown in the figure below. However, although some types of diseases, such as cystic fibrosis, can be definitively diagnosed by looking at certain genes, the experts GAO spoke with said that the medical predictions in the tests results can not be medically proven at this time. Even if the predictions could be medically proven, the way the results are presented renders them meaningless. For example, many people "may" be "at increased risk" for developing heart disease, so such an ambiguous statement could relate to any human that submitted DNA. Results from the tests that GAO purchased from Web sites 1 and 4 further mislead the consumer by recommending costly dietary supplements. The results from the tests from Web site 1 suggested "personalized" supplements costing approximately $1,200 per year. However, after examining the list of ingredients, GAO found that they were substantially the same as typical vitamins and antioxidants that can be found in any grocery store for about $35 per year. Results from the tests from Web site 4 suggested expensive products that claimed to repair damaged DNA. However, the experts GAO spoke with stated that there is no "pill" currently available that has been proven to do so. The experts also told us that, in some circumstances, taking supplements such as those recommended may be harmful. In addition, results from the tests that GAO purchased from Web sites 1, 2, and 3 do not provide recommendations based on a unique genetic profile as promised, but instead provide a number of common sense health recommendations. If the recommendations were truly based on genetic analysis, then the 9 fictitious consumers that GAO created for these sites using the female DNA should have received the same recommendations because their DNA came from the same source. Instead, they received a variety of different recommendations, depending on their fictitious lifestyles. For example, when GAO created lifestyle descriptions stating that the consumers smoked, they received recommendations to stop smoking. In contrast, if GAO said the consumers never smoked, they received recommendations to continue to avoid smoking.