	Test Results Are Misleading and of Little Use to Consumers

The test results we received are misleading and of little or no practical use  to consumers. Comparing results for 15 diseases, we made the following  observations: (1) each donor’s factual profile received disease risk  predictions that varied across all four companies, indicating that identical  DNA can yield contradictory results depending solely on the company it  was sent to for analysis; (2) these risk predictions often conflicted with the  donors’ factual illnesses and family medical histories; (3) none of the  companies could provide the donors who submitted fictitious African  American and Asian profiles with complete test results for their ethnicity  but did not explicitly disclose this limitation prior to purchase; (4) one  company provided donors with reports that showed conflicting  predictions for the same DNA and profile, but did not explain how to  interpret these different results; and (5) follow-up consultations offered by  three of the companies provided only general information and not the  expert advice the companies promised to provide. For  hypertension, Company 3 found that he had an above-average risk of  developing the condition, Company 2 found that he was at below- average risk, and Company 1 found he was at average risk. When we asked the representatives  whether they thought that any DTC genetic test companies currently on  the market were more accurate than others, all claimed that their own  companies’ tests were better than those offered by their competitors. the science of risk prediction based on genetic markers  is not fully worked out, and that the limitations inherent in this sort of risk  prediction have not been adequately disclosed.” As one expert further  noted, “the fact that different companies, using the same samples, predict  different…directions of risk is telling and is important. It shows that we  are nowhere near really being able to interpret .” We also asked  our experts if any of our donors should be concerned if the companies all  agreed on a risk prediction; for example, all four companies told Donor 1  she was at increased risk for Alzheimer’s disease. Risk predictions sometimes conflict with diagnosed medical  conditions or family history: Four of our five donors received test  results that conflicted with their factual medical conditions and family  histories. Donor 4 had a pacemaker implanted 13 years ago to treat atrial  fibrillation. The company did not  disclose this limitation prior to purchase even though it requested that  consumers specify their race or ethnicity during the purchase process. When Donor 4 expressed  concern that his doctor may not know what to do with the test results,  the expert told him “True, not all physicians are familiar with these  tests, so if you were to take it into a physician’s office, they may not be  familiar with it.” Furthermore, when discussing Donor 3’s increased  risk for colon cancer, one of Company 2’s experts told our donor that  while he should become familiar with the symptoms such as blood in  the stool, there was not much else he could do because “colon cancer  is quite silent.”
Company 3 states that “because of the complexity and inherent  uncertainties in genetic information, we recommend that you discuss  the results of your genetic test with a genetic professional….Our on- staff Genetic Counselors are available any time to review your…results  with you.” In our post-test interviews, the company further claimed that  its genetic counselors are certified by the American Board of Genetic  Counseling and that the counselors review family history and provide  consumers with additional information that is not in the test results. For  example, at least four companies claimed that a consumer’s DNA could be  used to create personalized supplements to cure diseases. One company’s  representative fraudulently used endorsements from high-profile athletes  to try to convince our undercover investigators to purchase its  supplements. Another flagrant example  of deceptive marketing involved several companies’ claims that they could  predict which sports children would excel in based on DNA analysis. Selected audio clips from our  undercover calls and meetings are available at  http://www.gao.gov/products/GAO-10-847T. Moreover, an expert we spoke with told us that there is no  scientific basis for claiming that supplements can be customized to DNA. In addition,  we have referred all the companies we investigated to FDA and FTC for  appropriate action.
Why GAO Did This Study

In 2006, GAO investigated companies selling direct-to-consumer (DTC) genetic tests and testified that these companies made medically unproven disease predictions. Although new companies have since been touted as being more reputable--Time named one company's test 2008's "invention of the year"--experts remain concerned that the test results mislead consumers. GAO was asked to investigate DTC genetic tests currently on the market and the advertising methods used to sell these tests. GAO purchased 10 tests each from four companies, for $299 to $999 per test. GAO then selected five donors and sent two DNA samples from each donor to each company: one using factual information about the donor and one using fictitious information, such as incorrect age and race or ethnicity. After comparing risk predictions that the donors received for 15 diseases, GAO made undercover calls to the companies seeking health advice. GAO did not conduct a scientific study but instead documented observations that could be made by any consumer. To assess whether the tests provided any medically useful information, GAO consulted with genetics experts. GAO also interviewed representatives from each company. To investigate advertising methods, GAO made undercover contact with 15 DTC companies, including the 4 tested, and asked about supplement sales, test reliability, and privacy policies. GAO again consulted with experts about the veracity of the claims.

What GAO Found

GAO's fictitious consumers received test results that are misleading and of little or no practical use. For example, GAO's donors often received disease risk predictions that varied across the four companies, indicating that identical DNA samples yield contradictory results. One donor was told that he was at below-average, average, and above-average risk for prostate cancer and hypertension. GAO's donors also received DNA-based disease predictions that conflicted with their actual medical conditions--one donor who had a pacemaker implanted 13 years ago to treat an irregular heartbeat was told that he was at decreased risk for developing such a condition. Also, none of the companies could provide GAO's fictitious African American and Asian donors with complete test results, but did not explicitly disclose this limitation prior to purchase. Further, follow-up consultations offered by three of the companies failed to provide the expert advice that the companies promised. In post-test interviews with GAO, each of the companies claimed that its results were more accurate than the others'. Although the experts GAO spoke with believe that these tests show promise for the future, they agreed that consumers should not rely on any of the results at this time. As one expert said, "the fact that different companies, using the same samples, predict different directions of risk is telling and is important. It shows that we are nowhere near really being able to interpret [such tests]." GAO also found 10 egregious examples of deceptive marketing, including claims made by four companies that a consumer's DNA could be used to create personalized supplement to cure diseases. Two of these companies further stated that their supplements could "repair damaged DNA" or cure disease, even though experts confirmed there is no scientific basis for such claims. One company representative even fraudulently used endorsements from high-profile athletes to convince GAO's fictitious consumer to purchase such supplements. Two other companies asserted that they could predict in which sports children would excel based on DNA analysis, claims that an expert characterized as "complete garbage." Further, two companies told GAO's fictitious consumer that she could secretly test her fiance's DNA to "surprise" him with test results--though this practice is restricted in 33 states. Perhaps most disturbing, one company told a donor that an above average risk prediction for breast cancer meant she was "in the high risk of pretty much getting" the disease, a statement that experts found to be "horrifying" because it implies the test is diagnostic. To hear clips of undercover contacts, see http://www.gao.gov/products/GAO-10-847T . GAO has referred all the companies it investigated to the Food and Drug Administration and Federal Trade Commission for appropriate action.