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Testimony: 

Before the Subcommittee on Oversight and Investigations, Committee on 
Energy and Commerce, House of Representatives: 

United States Government Accountability Office: 
GAO: 

For Release on Delivery: 
Expected at 9:30 a.m. EDT:
Thursday, July 22, 2010: 

Direct-To-Consumer Genetic Tests: 

Misleading Test Results Are Further Complicated by Deceptive Marketing 
and Other Questionable Practices: 

Statement of Gregory Kutz, Managing Director: 
Forensic Audits and Special Investigations: 

GAO-10-847T: 

GAO Highlights: 

Highlights of GAO-10-847T, a testimony before the Subcommittee on 
Oversight and Investigations, Committee on Energy and Commerce, House 
of Representatives. 

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. As shown below, one donor was told that he was at below-
average, average, and above-average risk for prostate cancer and 
hypertension. 

Table: Contradictory Risk Predictions for Prostate Cancer and 
Hypertension: 

Gender: Male; 
Age: 48; 
Condition: Prostate cancer; 
Company 1: Average; 
Company 2: Average; 
Company 3: Below average; 
Company 4: Above average. 

Gender: Male; 
Age: 48; 
Condition: Hypertension; 
Company 1: Average; 
Company 2: Below average; 
Company 3: Above average; 
Company 4: Not tested. 

Source: GAO. 

[End of table] 

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 fiancé’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 [hyperlink, 
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. 

View [hyperlink, http://www.gao.gov/products/GAO-10-847T] or key 
components. For more information, contact Gregory Kutz at (202) 512-
6722 or kutzg@gao. 

[End of section] 

Mr. Chairman and Members of the Subcommittee: 

Thank you for the opportunity to discuss our follow-up investigation 
of genetic tests sold directly to consumers via the Internet. Using 
kits at home, consumers simply swab their cheeks or collect saliva and 
send these DNA samples back to a company for analysis and a report of 
the results. While the importance of genetics in individual medical 
care shows promise for the future, the usefulness of the tests these 
companies offer is much debated. 

In 2006, we investigated four companies selling direct-to-consumer 
(DTC) genetic tests that purported to use DNA to deliver personalized 
nutrition and lifestyle guidance. We testified before the Senate 
Special Committee on Aging that these companies misled consumers by 
providing test results that were both medically unproven and so 
ambiguous as to be meaningless.[Footnote 1] For example, one of the 
results we received vaguely indicated that our DNA donor was at 
"significant risk of developing the age related conditions associated 
with elevated levels of DNA damage." Another stated that our donor had 
"faulty methylation patterns" that may lead to "an above-average risk 
for developing cardiac aging, brain aging, and cancer." And though 
some of the companies claimed that they would provide lifestyle advice 
based on a consumer's DNA, we found that they simply provided 
generally accepted health guidance linked to background information 
submitted by our donors on test questionnaires. Further, two of the 
companies we tested recommended costly dietary supplements that were 
in reality nothing more than inexpensive multivitamins available at 
any drug store. 

As a result of these findings, in 2006 the Centers for Disease Control 
and Prevention (CDC) in conjunction with the Food and Drug 
Administration (FDA) and the Federal Trade Commission (FTC) issued 
alerts warning consumers to be wary of claims made by these types of 
DTC genetic testing companies. In October 2008, FTC again warned 
consumers that "no standards govern the reliability or quality of at- 
home genetic tests. The FDA and Centers for Disease Control and 
Prevention recommend that genetic tests be done in a specialized 
laboratory and that a doctor or counselor with specialized training 
interpret the results." 

Despite these warnings, several new DTC genetic test companies have 
been touted as being more reputable and medically accurate than those 
we tested previously; in 2008, Time magazine named one new company's 
test the "invention of the year." More recently, another company's 
plan to sell tests at retail pharmacies has drawn significant 
attention from the media and scientists. However, given the scientific 
evidence currently available, many experts remain concerned that the 
medical predictions contained in the results mislead consumers. In 
this context, you requested that we proactively test DTC genetic 
products currently on the market and the advertising methods used to 
sell these products to consumers. 

To investigate DTC genetic products currently on the market, we 
purchased tests, for $299 to $999, from a nonrepresentative selection 
of four of the dozens of genetic testing companies selling kits to 
consumers on the Internet.[Footnote 2] Using online search terms 
likely to be used by actual consumers, we identified and selected 
these companies because they were frequently cited as being credible 
by the media and in scientific publications and because they all 
provided consumers with risk predictions, accessible through secure 
Web sites, for a range of diseases and conditions.[Footnote 3] 
Although their tests are not identical, all four companies' Web sites 
contain a variation of the statement that their tests help consumers 
and their physicians detect disease risks early so that they can take 
preventive steps to reduce these risks. They also note that their 
tests are not intended to provide medical advice or to treat or 
diagnose disease. We purchased 10 tests from each company (40 tests in 
total) to compare risk predictions for a variety of serious illnesses 
and determine whether the companies were consistent in their 
predictions. We selected for comparison 15 common diseases and 
conditions that were tested by at least three of the four companies: 
Alzheimer's disease, atrial fibrillation (a type of irregular heart 
beat), breast cancer, celiac disease (a chronic digestive problem 
caused by an inability to process gluten), colon cancer, heart attack, 
hypertension, leukemia, multiple sclerosis, obesity, prostate cancer, 
restless leg syndrome, rheumatoid arthritis, type 1 diabetes, and type 
2 diabetes.[Footnote 4] 

As shown in table 1, we then selected five DNA donors and created two 
profiles for each donor, one using factual information about the donor 
and one using fictitious information, including age, race or 
ethnicity, and medical history. 

Table 1: Donor and Profile Information: 

Donor: 1; 
Profile: Factual; 
Gender: Female; 
Age: 37; 
Race or Ethnicity: Caucasian; 
Selected Medical History Information: Colon cancer. 

Donor: 1; 
Profile: Fictitious; 
Gender: Female; 
Age: 68; 
Race or Ethnicity: African American; 
Selected Medical History Information: Hypertension and diabetes. 

Donor: 2; 
Profile: Factual; 
Gender: Female; 
Age: 41; 
Race or Ethnicity: Caucasian; 
Selected Medical History Information: Breast cancer, diabetes, and 
heart disease. 

Donor: 2; 
Profile: Fictitious; 
Gender: Female; 
Age: 19; 
Race or Ethnicity: Asian; 
Selected Medical History Information: Heart arrhythmias. 

Donor: 3; 
Profile: Factual; 
Gender: Male; 
Age: 48; 
Race or Ethnicity: Caucasian; 
Selected Medical History Information: Asthma, non-melanoma skin 
cancer, and heart disease. 

Donor: 3; 
Profile: Fictitious; 
Gender: Male; 
Age: 69; 
Race or Ethnicity: African American; 
Selected Medical History Information: Auto-immune disorders. 

Donor: 4; 
Profile: Factual; 
Gender: Male; 
Age: 61; 
Race or Ethnicity: Caucasian; 
Selected Medical History Information: Colon cancer, heart disease, and 
atrial fibrillation. 

Donor: 4; 
Profile: Fictitious; 
Gender: Male; 
Age: 53; 
Race or Ethnicity: Caucasian; 
Selected Medical History Information: Prostate cancer and hypertension. 

Donor: 5; 
Profile: Factual; 
Gender: Male; 
Age: 63; 
Race or Ethnicity: Caucasian; 
Selected Medical History Information: Type 2 diabetes, Alzheimer's 
disease, and obesity. 

Donor: 5; 
Profile: Fictitious; 
Gender: Male; 
Age: 29; 
Race or Ethnicity: Hispanic; 
Selected Medical History Information: Asthma and thyroid and colon 
cancer. 

Source: GAO: 

Note: We did not alter the gender on the donors' fictitious profiles 
because we believed that this difference would have been easily 
identified by these companies. 

[End of table] 

For each donor, we sent two DNA samples (saliva or a cheek swab) to 
each company--one sample using the factual profile and one using the 
fictitious--to determine whether altering the donors' backgrounds had 
any effect on the companies' DNA analysis. Three of the four companies 
asked for age and race or ethnicity prior to purchase; only one asked 
for medical history information. We also made undercover telephone 
calls to the companies seeking additional medical advice for both our 
factual and fictitious donors. We then documented our observations on 
the test results and advice we received. It is important to emphasize 
that we did not conduct a rigorous scientific study; our observations 
are those that could be made by any consumer. To assess whether we 
received any scientifically based or medically useful information, we 
consulted with external experts in the field of genetics and 
incorporated their comments as appropriate. Our primary consultant was 
Dr. James Evans, the Director of Adult Genetics Services at the 
University of North Carolina and the Editor-in-Chief of Genetics in 
Medicine, the official journal of the American College of Medical 
Genetics. After we completed our proactive testing, we visited each 
company and interviewed representatives who were willing to speak with 
us. We did not notify the companies prior to these visits and did not 
specifically disclose the results of our undercover testing or reveal 
the identities of our donors or the other companies that we tested. 

To investigate the advertising methods used to sell DTC genetic 
products, we reviewed the Web sites of a nonrepresentative selection 
of 15 genetic testing companies, including the 4 from which we 
purchased tests. We identified the companies by again using online 
search terms likely to be used by actual consumers. Posing as 
fictitious consumers, we made contact with these companies, both by 
phone and in person, seeking additional information about genetic 
testing. During these contacts, we asked a series of questions about 
the reliability and usefulness of test results, privacy policies 
regarding consumers' genetic information, and the sale of supplements 
or other products. To assess the accuracy and reasonableness of the 
marketing claims, we again consulted with external experts in the 
field of genetics. We also purchased supplements sold by one of the 
companies. 

Our findings are limited to the individual DTC genetic test companies 
we investigated and cannot be projected to any other companies. We 
performed our work from June 2009 to June 2010 in accordance with 
standards prescribed by the Council of Inspectors General for 
Integrity and Efficiency. 

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. The experts we spoke with 
agreed that the companies' claims and test results are both ambiguous 
and misleading. Further, they felt that consumers who are concerned 
about their health should consult directly with their physicians 
instead of purchasing these kinds of DTC genetic tests. See appendix I 
for comprehensive information on the test results we received for each 
donor. 

Different companies often provide different results for identical DNA: 
Each donor received risk predictions for the 15 diseases that varied 
from company to company, demonstrating that identical DNA samples 
produced contradictory results. Specifically, in reviewing the test 
results across all four companies for the donors' factual profiles, we 
found that Donor 1 had contradictory results for 11 diseases, Donor 2 
for 9 diseases, Donor 3 for 12 diseases, Donor 4 for 10 diseases, and 
Donor 5 for 9 diseases. Specific examples of these contradictory 
predictions are listed below; note that some of the diseases we 
compared were only tested by three of the four companies. To 
facilitate comparison among companies, we chose to use the terms 
"below average," "average," and "above average" to describe the risk 
predictions we received; the exact language used by each of the 
companies is reprinted in appendix I. 

* For Donor 1, Company 1 predicted an above-average risk of developing 
leukemia, while Company 2 predicted a below-average risk, and Company 
3 reported that she had an average risk for developing the disease. In 
addition, Companies 2 and 4 told the donor that her risk for 
contracting breast cancer was above average, but Companies 1 and 3 
found her only to be at average risk. See figure 1. 

Figure 1: Selected Contradictory Risk Predictions for Donor 1: 

[Refer to PDF for image: illustrated table] 

Gender: Female; 
Age: 37; 
Condition: Leukemia; 
Company 1: Above average; 
Company 2: Below average; 
Company 3: Average; 
Company 4: Not tested. 

Gender: Female; 
Age: 37; 
Condition: Breast cancer; 
Company 1: Above average; 
Company 2: Below average; 
Company 3: Above average; 
Company 4: Above average. 

Source: GAO. 

[End of figure] 

* Companies 1 and 2 claimed that Donor 2 had an above-average risk of 
developing type 1 diabetes, while Company 3 reported that she was at 
below-average risk for the disease. Further, Company 2 predicted she 
was at above-average risk for restless leg syndrome, Company 1 claimed 
she was at below-average risk for the condition, and Company 4 found 
that she was at average risk. See figure 2. 

Figure 2: Selected Contradictory Risk Predictions for Donor 2: 

[Refer to PDF for image: illustrated table] 

Gender: Female; 
Age: 41; 
Condition: Type 1 diabetes; 
Company 1: Above average; 
Company 2: Above average; 
Company 3: Below average; 
Company 4: Not tested. 

Gender: Female; 
Age: 41; 
Condition: Restless leg syndrome; 
Company 1: Below average; 
Company 2: Above average; 
Company 3: Not tested; 
Company 4: Average. 

Source: GAO. 

[End of figure] 

* Company 4 claimed that Donor 3's risk of developing prostate cancer 
was above-average, Company 3 found that he was at below-average risk, 
and Companies 1 and 2 found that he was at average risk. 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. See figure 3. 

Figure 3: Selected Contradictory Risk Predictions for Donor 3: 

[Refer to PDF for image: illustrated table] 

Gender: Male; 
Age: 48; 
Condition: Prostate cancer; 
Company 1: Average; 
Company 2: Average; 
Company 3: Below average; 
Company 4: Above average. 

Gender: Male; 
Age: 48; 
Condition: Hypertension; 
Company 1: Average; 
Company 2: Below average; 
Company 3: Above average; 
Company 4: Not tested. 

Source: GAO. 

[End of figure] 

* Donor 4 was told by Companies 1 and 4 that he was at above-average 
risk for celiac disease, but Company 2 reported that he was only at 
average risk. In addition, Companies 1 and 4 found that he was at 
below-average risk for multiple sclerosis, while Companies 2 and 3 
found that he was at average risk. See figure 4. 

Figure 4: Selected Contradictory Risk Predictions for Donor 4: 

[Refer to PDF for image: illustrated table] 

Gender: Male; 
Age: 61; 
Condition: Celiac disease; 
Company 1: Above average; 
Company 2: Average; 
Company 3: Not tested; 
Company 4: Above average. 

Gender: Male; 
Age: 61; 
Condition: Multiple sclerosis; 
Company 1: Below average; 
Company 2: Average; 
Company 3: Average; 
Company 4: Below average. 

Source: GAO. 

[End of figure] 

* For Donor 5, Companies 2 and 3 reported an above-average risk for 
heart attacks, and Companies 1 and 4 identified only an average risk. 
Company 2 found him to be at below-average risk[Footnote 5] for atrial 
fibrillation, while Companies 1, 3, and 4 predicted an average risk. 
See figure 5. 

Figure 5: Selected Contradictory Risk Predictions for Donor 5: 

[Refer to PDF for image: illustrated table] 

Gender: Male; 
Age: 63; 
Condition: Heart attack; 
Company 1: Average; 
Company 2: Above average; 
Company 3: Above average; 
Company 4: Average. 

Gender: Male; 
Age: 63; 
Condition: Atrial fibrillation; 
Company 1: Average; 
Company 2: Below average; 
Company 3: Average; 
Company 4: Average. 

Source: GAO. 

[End of figure] 

These contradictions can be attributed in part to the fact that the 
companies analyzed different genetic "markers" in assessing the 
donors' risk for disease. As described in a recent article published 
in the science journal Nature, researchers determine which markers 
occur more frequently in patients with a specific disease by 
conducting "genome-wide association studies, which survey hundreds of 
thousands or millions of markers across control and disease 
populations."[Footnote 6] DTC companies use these publicly available 
studies to decide which markers to include in their analyses, but none 
of the companies we investigated used the exact same markers in its 
tests. For example, Company 1 looked at 5 risk markers for prostate 
cancer, while Company 4 looked at 18 risk markers. 

In our post-test interviews, representatives from all four companies 
acknowledged that, in general, DTC genetic test companies test for 
different risk markers and that this could result in companies having 
different results for identical DNA. 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. 
For example, Company 1 said that it offers consumers more information 
than other companies because its results are based on both preliminary 
research reports as well as clinical data. Company 2 claimed that 
other companies do not test for as many markers as it does and that 
while none of the companies are "wrong," using more markers is 
"probably more accurate." Company 2 also stated that disparate test 
results from different companies are "caused, in part, due to a lack 
of guidance from the federal government, CDC in particular." Company 3 
similarly claimed to test for more markers than other companies and 
stated that its test is "the best." Company 3 also said that there is 
a movement within the DTC genetic test industry to standardize test 
results, but that such standardization is a work in progress. Finally, 
Company 4 claimed that it uses stricter criteria to select risk 
markers than other companies. Company 4 also told us that it has been 
involved in a collaborative effort with other DTC genetic test 
companies to develop standard sets of markers, but stated that there 
are many unresolved differences in philosophy and approach. 

When we asked genetics experts if any of the companies' markers and 
disease predictions were actually more accurate than the others, they 
told us that there are too many uncertainties and ambiguities in this 
type of testing to rely on any of the results. Unlike well-established 
genetic testing for diseases like cystic fibrosis, the experts feel 
that these tests are "promising for research, but the application is 
premature." In other words, "each company's results could be 
internally consistent, but not tell the full story….[because] 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 [such 
tests]." 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. The experts told us this consensus means very 
little because there are so many demographic, environmental, and 
lifestyle factors that contribute to the occurrence of the types of 
diseases tested by the four companies. 

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. 
[Footnote 7] When we asked the experts about these discrepancies, they 
told us that the results from these DTC tests are not conclusive 
because the tests are not diagnostic, as is noted on all of the 
companies Web sites. Because risks are probabilistic by definition, it 
is very likely that consumers will receive results from these 
companies that do not comport with their knowledge of their own 
medical histories. However, one expert noted that the discrepancies 
between actual health and the predications made by these companies 
also serve to illustrate the lack of robustness of such predictive 
tests. Moreover, experts fear that consumers may misinterpret the test 
results because they do not understand such distinctions. For example, 
a consumer with a strong family history of heart disease may be 
falsely reassured by below-average risk predictions related to heart 
attacks and consequently make poor health choices. In fact, one expert 
told us that "family history is still by far the most consistent risk 
factor for common chronic conditions. The presence of family history 
increases the risk of disease regardless of genetic variants and the 
current genetic variants do not explain the familial clustering of 
diseases." Another expert stated that "the most accurate way for these 
companies to predict disease risks would be for them to charge 
consumers $500 for DNA and family medical history information, throw 
out the DNA, and then make predictions based solely on the family 
history information." Examples we identified include the following: 

* Donor 2 has a family history of heart disease yet all four companies 
predicted that she was at average risk for having a heart attack. 
Donor 2 also has a family history of type 1 diabetes, but Company 3 
reported that she was at below-average risk for the disease. 

* Donor 3 has a family history of heart disease, but Companies 1, 2, 
and 3 reported that he was at average risk for having a heart attack 
and Company 4 reported he was at below-average risk. 

* Donor 4 had a pacemaker implanted 13 years ago to treat atrial 
fibrillation. However, Company 1 and 2 found that he was at below- 
average risk for developing atrial fibrillation,[Footnote 8] and 
Companies 3 and 4 claimed that he was at average risk. Donor 4 is also 
a colon cancer survivor, but Company 2 reported that he was at average 
risk of developing the disease. 

* Donor 5 has Type 2 diabetes, but Companies 1, 2, and 3 indicated 
that he had an average risk of developing the disease. Donor 5 is also 
overweight, but all four companies found him to be at average risk for 
obesity. 

In our post-test interviews, representatives from all four companies 
reiterated that their tests are not diagnostic, but they all believe 
that their tests provide consumers and their doctors with useful 
information. Specifically, Company 1 stressed that its tests empower 
consumers to recognize their risk of developing a health-related 
condition and then take the information to a doctor for further 
discussion. Company 2 emphasized that its tests provide consumers with 
the "incentive" to be "aggressive" about their health, while Company 3 
said its goal is to "empower individuals with information to help them 
make necessary lifestyle changes." Similarly, Company 4 stated that 
its risk predictions are a useful first step in that they offer 
"something for the consumer and their physician to consider in 
deciding whether or when to proceed with more invasive or costly 
tests." However, experts we spoke with cautioned that most doctors are 
not adequately prepared to use DTC genetic test information to treat 
patients. In addition, experts noted that there is currently no data 
or other evidence to suggest that consumers have taken steps to 
improve their health as a result of taking DTC genetic tests. As one 
expert noted, "even if such information is found to be an especially 
effective motivator of behavioral change, we're in trouble…because for 
everyone you find who is at increased disease risk, you'll find 
another who is at decreased risk. So if this information is actually 
powerful in motivating behavior then it will also motivate undesirable 
behaviors in those found to be at low risk." 

Fictitious profiles did not receive complete test results: Many of 
these studies the companies use to make risk predictions apply only to 
those of European ancestry. Consequently, our fictitious Asian and 
African American donors did not always receive risk predictions that 
were applicable to their race or ethnicity, although the companies 
either did not disclose these limitations prior to purchase or placed 
them in lengthy consent forms. The experts we spoke to agreed that 
these limitations should be "clearly disclosed upfront" and suggested 
that our fictitious donors try to get their money back. Companies 2 
and 3 did give us a refund, but Company 1 refused and company 4 never 
responded to our request. In our post-test interviews, company 
representatives acknowledged that race and ethnicity do affect disease 
risk predictions, but that most genetic research has only been done on 
persons of European ancestry and therefore such individuals receive 
more accurate results. Representatives from Company 1 also said that 
the company can provide only current information and that one of its 
primary goals is to expand upon this research by collecting DNA from 
as many persons as possible. Further, Companies 2 and 4 stated that 
they believe they communicate this limitation to consumers on their 
Web sites or in their test result reports, though our observations do 
not support this claim. Examples of the discrepancies we identified 
include the following: 

* Company 1 provided Donor 1's fictitious African American profile 
with test results based on her race for just 1 of the 15 diseases we 
compared: type 2 diabetes. For the remaining diseases, Company 1 
provided a risk prediction but included a disclaimer, such as "this 
result applies to people of European ancestry. We cannot yet compute 
more precise odds" for those of African American descent. However, 
Company 1 did not explicitly disclose the fact that African Americans 
would receive incomplete results prior to purchase, even though it did 
ask consumers to specify their ethnicity as part of the purchase 
process. The company only vaguely refers to any testing limitations on 
the first page of its consent form, which states that "gene/disease 
associations are typically based on ethnicity and the associations may 
not have been studied in many world populations and may not apply in 
the same or similar ways across populations." 

* Company 2 claimed on its Web site that it had "better coverage [of 
genes] associated with the most important diseases for all 
ethnicities" than its competitors. However, the company provided Donor 
2's fictitious Asian profile with test results for just 6 of the 15 
diseases we compared. The company did not explain these discrepancies 
and did not disclose the testing limitations prior to purchase, even 
though it requested that consumers specify their race or ethnicity as 
part of the purchase process. The only references to these limitations 
are made in the "frequently asked questions" section and on page six 
of an eight-page service agreement, where the company notes that "the 
genetic result reported may in some cases only be applicable to a 
certain group of people, e.g. based on gender, ethnicity, lifestyle, 
family history etc. that you may or may not belong to." 

* Company 3 sent Donor 3's fictitious African American profile results 
for just 3 of the 15 conditions we compared. 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. 

* For 10 of the 15 conditions we compared, Company 4 sent all of our 
donors results that applied only to individuals of European ancestry. 
However, for restless leg syndrome, the predictions were accompanied 
by the following statement: "most conditions have only been studied in 
people of European ancestry. But this condition is a little 
different." For atrial fibrillation, colon cancer, type 2 diabetes, 
and heart attack, the predictions were accompanied by the following 
statement "most conditions have only been studied in people of 
European ancestry, but this one also has been studied in other 
groups." The company provided no additional explanation as to how 
these differences applied to our donors. The only other reference to 
testing limitations is made on page five of a nine-page consent form, 
where the company notes that "most of the published studies in this 
area of genetic research have focused on people of Western European 
descent. We do not know if, or to what extent, these results apply to 
people of other backgrounds." 

Company 1 provided conflicting predictions for the same DNA within the 
same test result report: Company 1 provided our donors with 
conflicting risk predictions for atrial fibrillation, celiac disease, 
and obesity. In reviewing the test results for just the factual 
profiles, we observed the following: 

* Donor 1 received a "clinical report" predicting that she had an 
average risk for developing atrial fibrillation and a "research 
report" stating that she was at below-average risk for the disease. 

* Donor 2 received a "clinical report" stating that she was at below- 
average risk of developing celiac disease and a "research report" 
claiming that she was at above-average risk. 

* Donor 4 received one "research report" claiming that was at above- 
average risk for obesity and another "research report" stated that he 
was at average risk. 

According to information in the test results, the company 
distinguishes between clinical and research reports by noting that 
predictions based on the clinical reports are for "conditions and 
traits for which there are genetic associations supported by multiple, 
large, peer-reviewed studies." In contrast, the research reports 
provide information "that has not yet gained enough scientific 
consensus to be included in our clinical reports." However, there is 
no additional information explaining how consumers should interpret 
the results. Because the company does not offer any follow-up 
consultations on test results, our fictitious donors could not request 
clarification. When we interviewed representatives from Company 1 
about this issue after our testing, they simply reiterated the 
information contained in the results, describing research reports as 
being peer reviewed and "almost clinical" but noting that clinical 
reports are "four star" in that they are widely accepted according to 
scientific standards. 

Follow-up consultations provide only general information: As part of 
the test results, all four companies provide generally accepted health 
information related to the diseases that were tested, including a 
description of symptoms, treatments, and methods of prevention. This 
information is not targeted to specific consumers; all of our donors' 
results contained the same descriptions of treatments and methods of 
prevention, regardless of the risk predictions they received. For 
example, all the companies note that stopping smoking and increasing 
exercise are ways to reduce the risk for heart attacks. 
Representatives for Company 4 also encouraged consumers to make 
dietary changes such as adopting a Mediterranean diet or eating curry 
to prevent Alzheimer's disease, claims that cannot be proven, 
according to our experts. To supplement this information, Companies 2, 
3, and 4 offer follow-up consultations.[Footnote 9] Only Company 4 has 
U.S. board-certified genetic counselors on staff for this purpose, but 
all three companies claimed on their Web sites that their 
representatives would help consumers understand the implications of 
their disease risk predictions. However, for the most part, these 
representatives provided our donors with little guidance beyond the 
information contained in the test reports; at times, it seemed as 
though they were simply reading information directly from these 
reports. When our donors asked for more information on alarming 
results that indicated that they were at increased risk for serious 
diseases like colon cancer and Alzheimer's disease, representatives 
for Companies 2 and 3 pointed out symptoms to be aware of, but 
acknowledged that there is very little the donors could do to mitigate 
these risks. Representatives for Companies 2 and 4 also conceded that 
the donors' own doctors would probably not know what to do with the 
test results, a fact that our experts repeatedly noted. Examples 
include the following: 

* Company 2 offers follow up consultations with "experts" to help 
consumers "interpret their results." In our post-test interviews, the 
company further noted that it provides the option of speaking with 
genetic counselors or a medical geneticist, but that consumers rarely 
exercise this option. Because the company is located outside the 
country, we were unable to determine whether all of its counselors are 
board certified in the United States; however, one counselor told us 
that he was not certified. During one of our undercover follow-up 
calls, Donor 4 asked what to do about his test results in general and 
what lifestyle changes he should make as a result. The representative 
told Donor 4 that he could not tell him what to do because he was not 
a physician and that the donor should take his results to a physician 
if he wanted advice on making any changes. 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. However, our donors spoke to the same person, who admitted 
that she was not a board-certified genetic counselor. She told us that 
she had completed her master's in genetic counseling and just had to 
take her test to become licensed. Donor 5 called Company 3 because he 
was extremely concerned about the company's prediction that he had 
genetic markers that are highly correlated with Alzheimer's disease. 
Instead of providing addition information, the counselor simply 
acknowledged that "there is no cure or prevention strategy with 
Alzheimer's." 

* Company 4 notes that its "genetic counselors are healthcare 
professionals who are trained to help you understand what genetic 
information means for you and for your family." In our post-test 
interview, the company stressed that its counselors explain the 
results, discuss beneficial next steps, and ensure that consumers and 
their physicians understand the meaning and limitations of the tests. 
However, when Donor 2 asked what she could do about her test results, 
the counselor told her that she could take the results to a physician. 
When Donor 2 pressed the counselor about whether a doctor would know 
what to do, the counselor responded "With this stuff? Probably not, 
no, I think they're learning just like everyone else." 

"Personalized" Supplements, Bogus Endorsements, and Scientifically 
Invalid Claims among Deceptive Marketing Practices: 

Posing as consumers seeking information about genetic testing on the 
Internet and through phone calls and face-to-face meetings, we found 
that 10 of the 15 companies we investigated engaged in some form of 
fraudulent, deceptive, or otherwise questionable marketing practices. 
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. He also told our fictitious consumers that 
they could earn commission checks and receive free supplements if they 
could convince their friends to purchase the products. More detailed 
information on our experiences with this company follows table 2. 
Another flagrant example of deceptive marketing involved several 
companies' claims that they could predict which sports children would 
excel in based on DNA analysis. We also found examples of highly 
misleading representations about the reliability of the tests and the 
ability of health care practitioners to use the results to help treat 
patients. In addition, two companies are placing consumers' privacy at 
risk by condoning the potentially illegal practice of testing DNA 
without prior consent. Selected audio clips from our undercover calls 
and meetings are available at [hyperlink, 
http://www.gao.gov/products/GAO-10-847T]. Table 2 contains a selection 
of representations made by these companies. Note that companies 1 
through 4 are the same companies we proactively tested, as discussed 
earlier in this testimony. 

Table 2: Examples of Deceptive Marketing, Misinformation, and 
Questionable Practices: 

Source: Company 5; 
Representation: Representative claimed Michael Phelps used the 
companies' supplements. Representative also claimed that he would be 
meeting with Lance Armstrong because his doctors thought that test was 
"the most amazing thing they've ever seen;" 
Comments: Representatives for Michael Phelps and Lance Armstrong told 
us that they had never heard of this product and had no endorsements 
or dealings with the company. 

Source: Company 5; 
Representation: Company representative claimed that use of the 
company's supplements cured the arthritis in his knee and prevented 
him from getting high blood pressure and high cholesterol. He also 
suggested that our fictitious consumer could stop taking his 
cholesterol medication once he started taking the company's 
supplements; 
Comments: "Absolute lies," said one expert about these claims. Experts 
also stated that the claims have no scientific basis and consumers 
could suffer serious health consequences if they follow this advice. 
Moreover, FDA and the National Institutes of Health have noted that no 
dietary supplement can treat, prevent, or cure any disease. 

Source: Company 6; 
Representation: Genetic counselor claimed that tests and related 
products could help "repair damaged DNA;" 
Comments: Experts told us there is no scientific basis for this claim. 

Source: Companies 7 and 8; 
Representation: Companies claim to use a consumer's DNA and or 
genotype to create a "custom blend of nutrients" and "diet and 
exercise guidelines;" 
Comments: During a conversation with one of our fictitious consumers, 
a company representative admitted that supplements are just "high-
quality vitamins and minerals" and that diet and exercise guidelines 
are merely based on a consumer's responses to a questionnaire. Experts 
told us that there is no scientific basis for suggesting that 
supplements, diet, or exercise can be customized to DNA. 

Source: Companies 9 and 10; 
Representation: Web sites claim to be able to predict athletic 
performance by analyzing DNA and also to be able to determine which 
sports children will excel in; 
Comments: "In unqualified terms, [these claims] are complete garbage," 
according to one expert. 

Source: Companies 1, 2, 3, and 4; 
Representation: Web sites and company representatives told us that 
consumers should bring test results to their physicians to be used as 
a "tool" for treatment; 
Comments: According to the Department of Health and Human Services' 
Secretary's Advisory Committee on Genetics, Health, and Society, 
"[practitioners] cannot keep up with the pace of genetic tests and are 
not adequately prepared to use test information to treat patients 
appropriately." Therefore, direct to consumer genetic tests may not 
provide any substantial utility to the consumer. 

Source: Companies 4 and 9; 
Representation: Although their Web sites state that tests are not 
intended to diagnose diseases, a representative for Company 4 claimed 
that its tests were "diagnostic" and a representative for Company 9 
claimed that its tests were "prognostic" when asked about their 
reliability; 
Comments: Experts described these statements as "horrifying" and 
"disconcerting," because they could mislead consumers into thinking 
that they have a disease or provide a false sense of assurance that 
they don't. In addition, experts told us that for the types of 
conditions being tested by these companies, multiple studies have 
confirmed that DNA testing adds little to an analysis of a person's 
weight, age, gender, and family history. 

Source: Company 4; 
Representation: "You'd be in the high risk of pretty much getting it," 
is how a representative responded when our fictitious consumer asked 
if results indicating she was at above average risk for breast cancer 
meant she's definitely getting the disease; 
Comments: Experts also called this statement "disconcerting" and 
"horrifying" because it erroneously implies that the test can diagnose 
breast cancer and could needlessly alarm consumers. 

Source: Company 6; 
Representation: In response to general inquiries about genes and 
genetic testing, a representative stated that "genes are a symptom not 
a source of our biology;" 
Comments: An expert characterized this statement as "nonsensical." 

Source: Companies 3 and 4; 
Representation: Although company Web sites require consumers to 
explicitly consent to genetic testing before submitting a DNA sample, 
representatives from these companies told our fictitious consumer that 
she could secretly send in her fiancé's DNA and "surprise" him with 
the results; 
Comments: One expert characterized the companies' willingness to 
conduct tests without prior consent as "dangerous" and 
"irresponsible." According to the Johns Hopkins Genetic and Public 
Policy Center, this "surreptitious" testing could lead to people 
"learning of health risks or family relationships that he or she would 
prefer remain unknown." Currently 33 states place some type of 
restrictions on surreptitious testing.[A] 

Source: GAO. 

[A] For purposes of our testimony, surreptitious testing refers to the 
collection, analysis, or disclosure of the results of DNA samples 
without the consent of the person tested. State laws restricting 
surreptitious testing vary. For example, some states prohibit 
surreptitious testing for health-related purposes while other states 
restrict such testing for other purposes, including the determination 
of parentage. In a few states, the laws restricting surreptitious 
testing only apply to insurance companies. 

[End of table] 

Company 5: On its Web site, Company 5 claimed that it would use a 
consumer's DNA to "create a personalized formula for nutritional 
supplements and skin repair serum with 100% active ingredients 
individually selected to enhance or diminish the biological processes 
causing you to age." To investigate these claims, we posed as a 
fictitious consumer interested in purchasing the product and met in 
person with a company representative. 

During our initial meeting, the representative not only fraudulently 
suggested that Michael Phelps and representatives for Lance Armstrong 
endorsed the product, he also implied that the company's supplements 
could cure high cholesterol and arthritis, claims that one of our 
experts characterized as "absolute lies." Moreover, the FDA and the 
National Institutes of Health have clearly stated that no dietary 
supplement can treat, prevent, or cure any disease. As part of the 
company's promotional materials we found that the company's DNA 
assessment cost $225 and that the customized supplements cost about 
$145 per month. However, if our fictitious consumer immediately 
purchased a 3-month supply of supplements, she would be able to get 
the DNA test for free. The representative also told her that she could 
become a company affiliate and earn commission checks and free 
products by recruiting new affiliates. She, along with another 
fictitious consumer, subsequently registered as company affiliates, 
and ultimately received commission checks totaling more than $250. In 
addition to sending us the test kits, the company sent us packages of 
starter supplements in a bag that was not labeled with an ingredient 
list. 

In an attempt to compare the test results from Company 5 with the 
results we received from Companies 1 through 4, we again used the same 
five donors and replicated the same methodology: submitting DNA 
samples using one factual profile and one fictitious profile. However, 
when we received the results, we found that Company 5 did not provide 
a set of risk predictions for specific diseases, making it impossible 
for us to compare the results against those we received from the other 
four companies. Instead, the company sent our donors a list of gene 
variants tested, a description of bodily functions affected by those 
variants, and a determination of whether the donors needed additional 
"nutritional support" to maintain health. In comparing the results, we 
found that each donor appeared to have a unique assessment and that 
using the fictitious profile did not seem to affect the results. 
However, the results were so ambiguous and confusing that they did not 
provide meaningful information. For example: 

* Donor 1 was told that she needed "maximum support" to maintain the 
"VDR gene" which accounts for "75% of the entire genetic influence on 
bone density" among healthy people. Maximum support means that the 
"protein molecule expressing a specific enzyme, hormone, cytokine or 
structural protein is functioning minimally" and maximum nutritional 
support is needed to keep the body functioning optimally. 

* Donor 5 was told that he needed "added support" to maintain the 
"EPHX" gene, which "detoxifies" epoxides or "highly reactive foreign 
chemicals present in cigarette smoke, car exhaust, charcoal-grilled 
meat, smoke from wood burning, pesticides, and alcohol." "Added 
support" means that the gene is functioning less than optimally and 
therefore needs added nutritional support. 

According to one of the experts we spoke with, these claims are simply 
"nonsensical" and "while it is true that one can find alleles[Footnote 
10] of many of these genes that don't have the same activity as 
'normal,' we have no idea of (a) whether that reduced activity has any 
real health implications and (b) what one would reasonably do about it 
if so." 

Along with the test results, the company sent supplements that it 
claimed were "blended" based on our donors' DNA assessments. The 
supplements arrived in the same type of unlabeled bag as the starter 
supplements. This time, the ingredients were printed inside the test 
result booklet sent to each donor and included substances such as 
raspberry juice powder, green tea extract, and garlic powder. The 
recommended daily dose is 10 supplements per day. Based on a review of 
all the ingredient lists, our five donors appeared to get supplements 
with different combinations of substances. However, we did not test 
the supplements to verify their contents. Moreover, an expert we spoke 
with told us that there is no scientific basis for claiming that 
supplements can be customized to DNA. 

In post-test interviews, Company 5 told us that this company differs 
from others in that it does not attempt to diagnose or calculate a 
predisposition to any disease. Instead, the company said that it 
focuses on the overall health and well-being of their clients by 
creating personalized nutritional supplements based on their client's 
specific DNA. When we asked about the ingredients in the supplements, 
the company told us that all supplements have a base formula of 
ingredients that their scientists have determined to be "beneficial 
for everyone." Additional nutrients are then added to the base formula 
based on deficiencies identified by the company's DNA test. When we 
asked about the endorsements, we were told that several celebrities 
and professional athletes use the company's products, but that many of 
these high-profile clients do not want to disclose this affiliation. 

Corrective Action Briefings: 

We briefed FDA, the National Institutes of Health, and FTC on our 
findings on May 25, 2010; June 7, 2010; and June 17, 2010, 
respectively. In addition, we have referred all the companies we 
investigated to FDA and FTC for appropriate action. 

Mr. Chairman, this concludes my statement. I would be pleased to 
answer any questions that you or other members of the committee may 
have at this time. 

Contacts and Acknowledgments: 

For additional information about this testimony, please contact 
Gregory D. Kutz at (202) 512-6722 or kutzg@gao.gov. Contact points for 
our Offices of Congressional Relations and Public Affairs may be found 
on the last page of this statement. The following individuals made key 
contributions to this testimony: Jennifer Costello and Andrew 
O'Connell, Assistant Directors; Eric Eskew; Grant Fleming; Christine 
Hodakievic; Barbara Lewis; Vicki McClure; Ramon Rodriguez; Anthony 
Salvemini; Barry Shillito; Tim Walker; John Wilbur; and Emily Wold. 

[End of section] 

Appendix I: Test Results by Donor: 

This appendix provides (1) a description of both the factual and 
fictitious profiles used by each donor and (2) tables documenting the 
risk predictions we received from all four companies for the 15 
diseases we compared. 

To the extent possible, we have used in the risk prediction language 
directly from the test results. However, Company 2 did not use terms 
like "average" or "below average" to describe risk. Instead the 
company used charts showing each consumer's risk level as compared to 
others with the consumer's gender and ethnicity or as compared to 
those of European ancestry. The results were color coded, with green 
to light green appearing to correspond to a below-average risk level, 
yellow corresponding to an average risk level, and orange and red 
corresponding to an above-average risk level. To facilitate 
comparison, we chose to use these corresponding terms to describe the 
results, as shown in the table. In addition, Company 1 used two 
different types of reports in its test results: clinical and research. 
According to the company, the clinical reports contain "information 
about conditions and traits for which there are genetic associations 
supported by multiple, large, peer-reviewed studies." Research reports 
contain "information from research that has not yet gained enough 
scientific consensus to be included in our clinical reports." Where 
applicable, we noted when a risk prediction was derived from a 
research report; all the other predictions were derived from the 
clinical reports. 

Donor 1: Donor 1 is a 37-year old Caucasian female, who eats a 
balanced diet and exercises regularly. She has elevated cholesterol 
and arthritis in her back. In addition, she has a strong family 
history of colon cancer and a grandparent who was diagnosed with 
dementia. In Donor 1's fictitious profile, she is a 68-year old, 
African American female, who is overweight and rarely exercises. She 
has type 2 diabetes, hypertension, and asthma, but has no family 
history of colon cancer or dementia. 

Table 3: Comparison of Test Results for Donor 1: 

Disease or condition: Alzheimer's disease; 
Profile: Factual; 
Risk predictions: Company 1: Not tested; 
Risk predictions: Company 2: Above average; 
Risk predictions: Company 3: Increased susceptibility; 
Risk predictions: Company 4: Above average. 

Disease or condition: Alzheimer's disease; 
Profile: Fictitious; 
Risk predictions: Company 1: Not tested; 
Risk predictions: Company 2: Not tested; 
Risk predictions: Company 3: Increased susceptibility; 
Risk predictions: Company 4: Above average. 

Disease or condition: Atrial fibrillation; 
Profile: Factual; 
Risk predictions: Company 1: Typical and decreased (research); 
Risk predictions: Company 2: Average; 
Risk predictions: Company 3: Average predisposition; 
Risk predictions: Company 4: About average. 

Disease or condition: Atrial fibrillation; 
Profile: Fictitious; 
Risk predictions: Company 1: Typical and decreased (research); 
Risk predictions: Company 2: Not tested; 
Risk predictions: Company 3: Not tested; 
Risk predictions: Company 4: About average. 

Disease or condition: Breast cancer; 
Profile: Factual; 
Risk predictions: Company 1: Typical; 
Risk predictions: Company 2: Above average; 
Risk predictions: Company 3: Average predisposition; 
Risk predictions: Company 4: Greater than most women's. 

Disease or condition: Breast cancer; 
Profile: Fictitious; 
Risk predictions: Company 1: Typical; 
Risk predictions: Company 2: Not tested; 
Risk predictions: Company 3: Average predisposition; 
Risk predictions: Company 4: Greater than most women's. 

Disease or condition: Celiac disease; 
Profile: Factual; 
Risk predictions: Company 1: Decreased and typical (research); 
Risk predictions: Company 2: Average; 
Risk predictions: Company 3: Not tested; 
Risk predictions: Company 4: Below average. 

Disease or condition: Celiac disease; 
Profile: Fictitious; 
Risk predictions: Company 1: Decreased and typical (research); 
Risk predictions: Company 2: Not tested; 
Risk predictions: Company 3: Not tested; 
Risk predictions: Company 4: Below average. 

Disease or condition: Colon cancer; 
Profile: Factual; 
Risk predictions: Company 1: Elevated; 
Risk predictions: Company 2: Above average; 
Risk predictions: Company 3: Increased susceptibility; 
Risk predictions: Company 4: Above average. 

Disease or condition: Colon cancer; 
Profile: Fictitious; 
Risk predictions: Company 1: Elevated; 
Risk predictions: Company 2: Not tested; 
Risk predictions: Company 3: Not tested; 
Risk predictions: Company 4: Above average. 

Disease or condition: Heart attack; 
Profile: Factual; 
Risk predictions: Company 1: Decreased; 
Risk predictions: Company 2: Average; 
Risk predictions: Company 3: Average predisposition; 
Risk predictions: Company 4: Average. 

Disease or condition: Heart attack; 
Profile: Fictitious; 
Risk predictions: Company 1: Decreased; 
Risk predictions: Company 2: Not tested; 
Risk predictions: Company 3: Not tested; 
Risk predictions: Company 4: Average. 

Disease or condition: Hypertension; 
Profile: Factual; 
Risk predictions: Company 1: Elevated (research ); 
Risk predictions: Company 2: Average; 
Risk predictions: Company 3: Average predisposition; 
Risk predictions: Company 4: Not tested. 

Disease or condition: Hypertension; 
Profile: Fictitious; 
Risk predictions: Company 1: Elevated (research); 
Risk predictions: Company 2: Not tested; 
Risk predictions: Company 3: Not tested; 
Risk predictions: Company 4: Not tested. 

Disease or condition: Leukemia; 
Profile: Factual; 
Risk predictions: Company 1: Elevated (research); 
Risk predictions: Company 2: Below average; 
Risk predictions: Company 3: Average predisposition; 
Risk predictions: Company 4: Not tested. 

Disease or condition: Leukemia; 
Profile: Fictitious; 
Risk predictions: Company 1: Elevated (research); 
Risk predictions: Company 2: Not tested; 
Risk predictions: Company 3: Not tested; 
Risk predictions: Company 4: Not tested. 

Disease or condition: Multiple sclerosis; 
Profile: Factual; 
Risk predictions: Company 1: Decreased; 
Risk predictions: Company 2: Average; 
Risk predictions: Company 3: Average predisposition; 
Risk predictions: Company 4: Below average. 

Disease or condition: Multiple sclerosis; 
Profile: Fictitious; 
Risk predictions: Company 1: Decreased; 
Risk predictions: Company 2: Not tested; 
Risk predictions: Company 3: Not tested; 
Risk predictions: Company 4: Below average. 

Disease or condition: Obesity; 
Profile: Factual; 
Risk predictions: Company 1: Typical and typical (research); 
Risk predictions: Company 2: Below average; 
Risk predictions: Company 3: Average predisposition; 
Risk predictions: Company 4: Below average. 

Disease or condition: Obesity; 
Profile: Fictitious; 
Risk predictions: Company 1: Typical and typical (research); 
Risk predictions: Company 2: Not tested; 
Risk predictions: Company 3: Not tested; 
Risk predictions: Company 4: Below average. 

Disease or condition: Prostate cancer; 
Profile: Factual; 
Risk predictions: Company 1: Not applicable; 
Risk predictions: Company 2: Not applicable; 
Risk predictions: Company 3: Not applicable; 
Risk predictions: Company 4: Not applicable. 

Disease or condition: Prostate cancer; 
Profile: Fictitious; 
Risk predictions: Company 1: Not applicable; 
Risk predictions: Company 2: Not applicable; 
Risk predictions: Company 3: Not applicable; 
Risk predictions: Company 4: Not applicable. 

Disease or condition: Restless leg syndrome; 
Profile: Factual; 
Risk predictions: Company 1: Decreased; 
Risk predictions: Company 2: Below average; 
Risk predictions: Company 3: Not tested; 
Risk predictions: Company 4: Below average. 

Disease or condition: Restless leg syndrome; 
Profile: Fictitious; 
Risk predictions: Company 1: Decreased; 
Risk predictions: Company 2: Not tested; 
Risk predictions: Company 3: Not tested; 
Risk predictions: Company 4: Below average. 

Disease or condition: Rheumatoid arthritis; 
Profile: Factual; 
Risk predictions: Company 1: Decreased; 
Risk predictions: Company 2: Below average; 
Risk predictions: Company 3: Average predisposition; 
Risk predictions: Company 4: Below average. 

Disease or condition: Rheumatoid arthritis; 
Profile: Fictitious; 
Risk predictions: Company 1: Decreased; 
Risk predictions: Company 2: Not tested; 
Risk predictions: Company 3: Not tested; 
Risk predictions: Company 4: Below average. 

Disease or condition: Type 1 diabetes; 
Profile: Factual; 
Risk predictions: Company 1: Elevated; 
Risk predictions: Company 2: Above average; 
Risk predictions: Company 3: Do not show strong susceptibility; 
Risk predictions: Company 4: Not tested. 

Disease or condition: Type 1 diabetes;
Profile: Fictitious; 
Risk predictions: Company 1: Elevated; 
Risk predictions: Company 2: Not tested; 
Risk predictions: Company 3: Not tested; 
Risk predictions: Company 4: Not tested. 

Disease or condition: Type 2 diabetes; 
Profile: Factual; 
Risk predictions: Company 1: Typical; 
Risk predictions: Company 2: Average; 
Risk predictions: Company 3: Average predisposition; 
Risk predictions: Company 4: Below average. 

Disease or condition: Type 2 diabetes; 
Profile: Fictitious; 
Risk predictions: Company 1: Typical; 
Risk predictions: Company 2: Below average; 
Risk predictions: Company 3: Average predisposition; 
Risk predictions: Company 4: Below average. 

Source: GAO analysis of results from four companies. 

[End of table] 

Donor 2: Donor 2 is a 41-year-old Caucasian female. She is in good 
health; however she has a family history of breast cancer, type 1 
diabetes, and heart disease. In Donor 2's fictitious profile, she is a 
19-year-old Asian female who smokes, drinks and uses recreational 
drugs. She suffers from heart arrhythmias and an elevated resting 
heart rate, but has no family history of breast cancer or diabetes. 

Table 4: Comparison of Test Results for Donor 2: 

Disease or condition: Alzheimer's disease; 
Profile: Factual; 
Risk predictions: Company 1: Not tested; 
Risk predictions: Company 2: Below average; 
Risk predictions: Company 3: Do not show strong susceptibility; 
Risk predictions: Company 4: Below average. 

Disease or condition: Alzheimer's disease; 
Profile: Fictitious; 
Risk predictions: Company 1: Not tested; 
Risk predictions: Company 2: Not tested; 
Risk predictions: Company 3: Do not show strong susceptibility; 
Risk predictions: Company 4: Below average. 

Disease or condition: Atrial fibrillation; 
Profile: Factual; 
Risk predictions: Company 1: Elevated and typical (research); 
Risk predictions: Company 2: Average; 
Risk predictions: Company 3: Increased susceptibility; 
Risk predictions: Company 4: Above average. 

Disease or condition: Atrial fibrillation; 
Profile: Fictitious; 
Risk predictions: Company 1: Elevated and typical (research); 
Risk predictions: Company 2: Below average; 
Risk predictions: Company 3: Average predisposition; 
Risk predictions: Company 4: Above average. 

Disease or condition: Breast cancer; 
Profile: Factual; 
Risk predictions: Company 1: Typical; 
Risk predictions: Company 2: Above average; 
Risk predictions: Company 3: Average predisposition; 
Risk predictions: Company 4: Average. 

Disease or condition: Breast cancer; 
Profile: Fictitious; 
Risk predictions: Company 1: Typical; 
Risk predictions: Company 2: Average; 
Risk predictions: Company 3: Average predisposition; 
Risk predictions: Company 4: Average. 

Disease or condition: Celiac disease; 
Profile: Factual; 
Risk predictions: Company 1: Elevated and decreased (research); 
Risk predictions: Company 2: Below average; 
Risk predictions: Company 3: Not tested; 
Risk predictions: Company 4: Below average. 

Disease or condition: Celiac disease; 
Profile: Fictitious; 
Risk predictions: Company 1: Decreased and elevated (research); 
Risk predictions: Company 2: Not tested; 
Risk predictions: Company 3: Not tested; 
Risk predictions: Company 4: Below average. 

Disease or condition: Colon cancer; 
Profile: Factual; 
Risk predictions: Company 1: Typical; 
Risk predictions: Company 2: Below average; 
Risk predictions: Company 3: Average predisposition; 
Risk predictions: Company 4: Below average. 

Disease or condition: Colon cancer; 
Profile: Fictitious; 
Risk predictions: Company 1: Typical; 
Risk predictions: Company 2: Average; 
Risk predictions: Company 3: Increased susceptibility; 
Risk predictions: Company 4: Below average. 

Disease or condition: Heart attack; 
Profile: Factual; 
Risk predictions: Company 1: Typical; 
Risk predictions: Company 2: Average; 
Risk predictions: Company 3: Average predisposition; 
Risk predictions: Company 4: Average. 

Disease or condition: Heart attack; 
Profile: Fictitious; 
Risk predictions: Company 1: Typical; 
Risk predictions: Company 2: Below average; 
Risk predictions: Company 3: Average predisposition; 
Risk predictions: Company 4: Average. 

Disease or condition: Hypertension; 
Profile: Factual; 
Risk predictions: Company 1: Typical (research); 
Risk predictions: Company 2: Average; 
Risk predictions: Company 3: Increased susceptibility; 
Risk predictions: Company 4: Not tested. 

Disease or condition: Hypertension; 
Profile: Fictitious; 
Risk predictions: Company 1: Typical (research); 
Risk predictions: Company 2: Not tested; 
Risk predictions: Company 3: Increased susceptibility; 
Risk predictions: Company 4: Not tested. 

Disease or condition: Leukemia; 
Profile: Factual; 
Risk predictions: Company 1: Elevated (research); 
Risk predictions: Company 2: Average; 
Risk predictions: Company 3: Increased susceptibility; 
Risk predictions: Company 4: Not tested. 

Disease or condition: Leukemia; 
Profile: Fictitious; 
Risk predictions: Company 1: Elevated (research); 
Risk predictions: Company 2: Not tested; 
Risk predictions: Company 3: Not tested; 
Risk predictions: Company 4: Not tested. 

Disease or condition: Multiple sclerosis; 
Profile: Factual; 
Risk predictions: Company 1: Decreased; 
Risk predictions: Company 2: Average; 
Risk predictions: Company 3: Average predisposition; 
Risk predictions: Company 4: Below average. 

Disease or condition: Multiple sclerosis; 
Profile: Fictitious; 
Risk predictions: Company 1: Decreased; 
Risk predictions: Company 2: Not tested; 
Risk predictions: Company 3: Not tested; 
Risk predictions: Company 4: Below average. 

Disease or condition: Obesity; 
Profile: Factual; 
Risk predictions: Company 1: Typical and typical (research); 
Risk predictions: Company 2: Average; 
Risk predictions: Company 3: Average predisposition; 
Risk predictions: Company 4: About average. 

Disease or condition: Obesity; 
Profile: Fictitious; 
Risk predictions: Company 1: Typical and typical (research); 
Risk predictions: Company 2: Not tested; 
Risk predictions: Company 3: Increased susceptibility; 
Risk predictions: Company 4: About average. 

Disease or condition: Prostate cancer; 
Profile: Factual; 
Risk predictions: Company 1: Not applicable; 
Risk predictions: Company 2: Not applicable; 
Risk predictions: Company 3: Not applicable; 
Risk predictions: Company 4: Not applicable. 

Disease or condition: Prostate cancer; 
Profile: Fictitious; 
Risk predictions: Company 1: Not applicable; 
Risk predictions: Company 2: Not applicable; 
Risk predictions: Company 3: Not applicable; 
Risk predictions: Company 4: Not applicable. 

Disease or condition: Restless leg syndrome; 
Profile: Factual; 
Risk predictions: Company 1: Decreased; 
Risk predictions: Company 2: Above average; 
Risk predictions: Company 3: Not tested; 
Risk predictions: Company 4: About average. 

Disease or condition: Restless leg syndrome; 
Profile: Fictitious; 
Risk predictions: Company 1: Decreased; 
Risk predictions: Company 2: Not tested; 
Risk predictions: Company 3: Not tested; 
Risk predictions: Company 4: Abut average. 

Disease or condition: Rheumatoid arthritis; 
Profile: Factual; 
Risk predictions: Company 1: Decreased; 
Risk predictions: Company 2: Below average; 
Risk predictions: Company 3: Do not show strong susceptibility; 
Risk predictions: Company 4: Below average. 

Disease or condition: Rheumatoid arthritis; 
Profile: Fictitious; 
Risk predictions: Company 1: Typical; 
Risk predictions: Company 2: Average; 
Risk predictions: Company 3: Average predisposition; 
Risk predictions: Company 4: Below average. 

Disease or condition: Type 1 diabetes; 
Profile: Factual; 
Risk predictions: Company 1: Elevated; 
Risk predictions: Company 2: Above average; 
Risk predictions: Company 3: Do not show strong susceptibility; 
Risk predictions: Company 4: Not tested. 

Disease or condition: Type 1 diabetes; 
Profile: Fictitious; 
Risk predictions: Company 1: Elevated; 
Risk predictions: Company 2: Not tested; 
Risk predictions: Company 3: Increased susceptibility; 
Risk predictions: Company 4: Not tested. 

Disease or condition: Type 2 diabetes; 
Profile: Factual; 
Risk predictions: Company 1: Typical; 
Risk predictions: Company 2: Average; 
Risk predictions: Company 3: Average predisposition; 
Risk predictions: Company 4: About average. 

Disease or condition: Type 2 diabetes; 
Profile: Fictitious; 
Risk predictions: Company 1: Typical; 
Risk predictions: Company 2: Above average; 
Risk predictions: Company 3: Average predisposition; 
Risk predictions: Company 4: About average. 

Source: GAO analysis of results from four companies. 

[End of table] 

Donor 3: Donor 3 is a 48-year-old Caucasian male who has never smoked 
and rarely drinks. The donor has asthma as well as a family history of 
heart disease. In Donor 3's fictitious profile, he is a 69-year-old 
African American male who is overweight, smokes, and is in somewhat 
poor health. He has a family history of bone and lung cancer, but no 
history of asthma or heart disease. 

Table 5: Comparison of Test Results for Donor 3: 

Disease or condition: Alzheimer's disease; 
Profile: Factual; 
Risk predictions: Company 1: Not tested; 
Risk predictions: Company 2: Average; 
Risk predictions: Company 3: Increased susceptibility; 
Risk predictions: Company 4: Above average risk. 

Disease or condition: Alzheimer's disease; 
Profile: Fictitious; 
Risk predictions: Company 1: Not tested; 
Risk predictions: Company 2: Not tested; 
Risk predictions: Company 3: Increased susceptibility; 
Risk predictions: Company 4: Above average. 

Disease or condition: Atrial fibrillation; 
Profile: Factual; 
Risk predictions: Company 1: Typical and decreased (research); 
Risk predictions: Company 2: Average; 
Risk predictions: Company 3: Average predisposition; 
Risk predictions: Company 4: About average. 

Disease or condition: Atrial fibrillation; 
Profile: Fictitious; 
Risk predictions: Company 1: Typical and decreased (research); 
Risk predictions: Company 2: Not tested; 
Risk predictions: Company 3: Not tested; 
Risk predictions: Company 4: About average. 

Disease or condition: Breast cancer; 
Profile: Factual; 
Risk predictions: Company 1: Not applicable; 
Risk predictions: Company 2: Not applicable; 
Risk predictions: Company 3: Not applicable; 
Risk predictions: Company 4: Not applicable. 

Disease or condition: Breast cancer; 
Profile: Fictitious; 
Risk predictions: Company 1: Not applicable; 
Risk predictions: Company 2: Not applicable; 
Risk predictions: Company 3: Not applicable; 
Risk predictions: Company 4: Not applicable. 

Disease or condition: Celiac disease; 
Profile: Factual; 
Risk predictions: Company 1: Decreased and typical (research); 
Risk predictions: Company 2: Below average; 
Risk predictions: Company 3: Not tested; 
Risk predictions: Company 4: Below average. 

Disease or condition: Celiac disease; 
Profile: Fictitious; 
Risk predictions: Company 1: Decreased and typical (research); 
Risk predictions: Company 2: Not tested; 
Risk predictions: Company 3: Not tested; 
Risk predictions: Company 4: Below average. 

Disease or condition: Colon cancer; 
Profile: Factual; 
Risk predictions: Company 1: Typical; 
Risk predictions: Company 2: Above average; 
Risk predictions: Company 3: Increased susceptibility; 
Risk predictions: Company 4: Above average. 

Disease or condition: Colon cancer; 
Profile: Fictitious; 
Risk predictions: Company 1: Typical; 
Risk predictions: Company 2: Not tested; 
Risk predictions: Company 3: Not tested; 
Risk predictions: Company 4: Above average. 

Disease or condition: Heart attack; 
Profile: Factual; 
Risk predictions: Company 1: Typical; 
Risk predictions: Company 2: Average; 
Risk predictions: Company 3: Average predisposition; 
Risk predictions: Company 4: Below average. 

Disease or condition: Heart attack; 
Profile: Fictitious; 
Risk predictions: Company 1: Typical; 
Risk predictions: Company 2: Not tested; 
Risk predictions: Company 3: Not tested; 
Risk predictions: Company 4: Below average. 

Disease or condition: Hypertension; 
Profile: Factual; 
Risk predictions: Company 1: Typical (research); 
Risk predictions: Company 2: Below average; 
Risk predictions: Company 3: Increased susceptibility; 
Risk predictions: Company 4: Not tested. 

Disease or condition: Hypertension; 
Profile: Fictitious; 
Risk predictions: Company 1: Typical (research); 
Risk predictions: Company 2: Not tested; 
Risk predictions: Company 3: Not tested; 
Risk predictions: Company 4: Not tested. 

Disease or condition: Leukemia; 
Profile: Factual; 
Risk predictions: Company 1: Elevated (research); 
Risk predictions: Company 2: Average; 
Risk predictions: Company 3: Average predisposition; 
Risk predictions: Company 4: Not tested. 

Disease or condition: Leukemia; 
Profile: Fictitious; 
Risk predictions: Company 1: Elevated (research); 
Risk predictions: Company 2: Not tested; 
Risk predictions: Company 3: Not tested; 
Risk predictions: Company 4: Not tested. 

Disease or condition: Multiple sclerosis; 
Profile: Factual; 
Risk predictions: Company 1: Decreased; 
Risk predictions: Company 2: Average; 
Risk predictions: Company 3: Average predisposition; 
Risk predictions: Company 4: Below average. 

Disease or condition: Multiple sclerosis; 
Profile: Fictitious; 
Risk predictions: Company 1: Decreased; 
Risk predictions: Company 2: Not tested; 
Risk predictions: Company 3: Not tested; 
Risk predictions: Company 4: Below average. 

Disease or condition: Obesity; 
Profile: Factual; 
Risk predictions: Company 1: Typical and typical (research); 
Risk predictions: Company 2: Average; 
Risk predictions: Company 3: Average predisposition; 
Risk predictions: Company 4: About average. 

Disease or condition: Obesity; 
Profile: Fictitious; 
Risk predictions: Company 1: Typical and typical (research); 
Risk predictions: Company 2: Not tested; 
Risk predictions: Company 3: Not tested; 
Risk predictions: Company 4: About average. 

Disease or condition: Prostate cancer; 
Profile: Factual; 
Risk predictions: Company 1: Typical; 
Risk predictions: Company 2: Average; 
Risk predictions: Company 3: Do not show strong susceptibility; 
Risk predictions: Company 4: Greater than most men's. 

Disease or condition: Prostate cancer; 
Profile: Fictitious; 
Risk predictions: Company 1: Typical; 
Risk predictions: Company 2: Below average; 
Risk predictions: Company 3: Average predisposition; 
Risk predictions: Company 4: Greater than most men's. 

Disease or condition: Restless leg syndrome; 
Profile: Factual; 
Risk predictions: Company 1: Elevated; 
Risk predictions: Company 2: Average risk; 
Risk predictions: Company 3: Not tested; 
Risk predictions: Company 4: Higher than most people. 

Disease or condition: Restless leg syndrome; 
Profile: Fictitious; 
Risk predictions: Company 1: Elevated; 
Risk predictions: Company 2: Not tested; 
Risk predictions: Company 3: Not tested; 
Risk predictions: Company 4: Higher than most people. 

Disease or condition: Rheumatoid arthritis; 
Profile: Factual; 
Risk predictions: Company 1: Elevated; 
Risk predictions: Company 2: Above average; 
Risk predictions: Company 3: Average predisposition; 
Risk predictions: Company 4: Above average. 

Disease or condition: Rheumatoid arthritis; 
Profile: Fictitious; 
Risk predictions: Company 1: Elevated; 
Risk predictions: Company 2: Not tested; 
Risk predictions: Company 3: Not tested; 
Risk predictions: Company 4: Above average. 

Disease or condition: Type 1 diabetes; 
Profile: Factual; 
Risk predictions: Company 1: Elevated; 
Risk predictions: Company 2: Average; 
Risk predictions: Company 3: Do not show strong susceptibility; 
Risk predictions: Company 4: Not tested. 

Disease or condition: Type 1 diabetes; 
Profile: Fictitious; 
Risk predictions: Company 1: Elevated; 
Risk predictions: Company 2: Not tested; 
Risk predictions: Company 3: Not tested; 
Risk predictions: Company 4: Not tested. 

Disease or condition: Type 2 diabetes; 
Profile: Factual; 
Risk predictions: Company 1: Typical; 
Risk predictions: Company 2: Average; 
Risk predictions: Company 3: Average predisposition; 
Risk predictions: Company 4: About average. 

Disease or condition: Type 2 diabetes; 
Profile: Fictitious; 
Risk predictions: Company 1: Typical; 
Risk predictions: Company 2: Below average; 
Risk predictions: Company 3: Average predisposition; 
Risk predictions: Company 4: About average. 

Source: GAO analysis of results from four companies. 

[End of table] 

Donor 4: Donor 4 is a 61-year-old Caucasian male who smokes. The donor 
has elevated cholesterol, has an elevated resting heart rate, and has 
had colon cancer. Thirteen years ago, the donor had a pacemaker 
implanted to treat atrial fibrillation. In Donor 4's fictitious 
profile, he is a 53-year-old Caucasian male who has never smoked. He 
has hypertension and prostate cancer but has no family history of 
colon cancer or atrial fibrillation. 

Table 6: Comparison of Test Results for Donor 4: 

Disease or condition: Alzheimer's disease; 
Profile: Factual; 
Risk predictions: Company 1: Not tested; 
Risk predictions: Company 2: Below average; 
Risk predictions: Company 3: Not tested; 
Risk predictions: Company 4: Below average. 

Disease or condition: Alzheimer's disease; 
Profile: Fictitious; 
Risk predictions: Company 1: Not tested; 
Risk predictions: Company 2: Below average; 
Risk predictions: Company 3: Average predisposition; 
Risk predictions: Company 4: Below average. 

Disease or condition: Atrial fibrillation; 
Profile: Factual; 
Risk predictions: Company 1: Typical and decreased (research); 
Risk predictions: Company 2: Below average; 
Risk predictions: Company 3: Average predisposition; 
Risk predictions: Company 4: About average. 

Disease or condition: Atrial fibrillation; 
Profile: Fictitious; 
Risk predictions: Company 1: Typical and decreased (research ); 
Risk predictions: Company 2: Below average; 
Risk predictions: Company 3: Average predisposition; 
Risk predictions: Company 4: About average. 

Disease or condition: Breast cancer; 
Profile: Factual; 
Risk predictions: Company 1: Not applicable; 
Risk predictions: Company 2: Not applicable; 
Risk predictions: Company 3: Not applicable; 
Risk predictions: Company 4: Not applicable. 

Disease or condition: Breast cancer; 
Profile: Fictitious; 
Risk predictions: Company 1: Not applicable; 
Risk predictions: Company 2: Not applicable; 
Risk predictions: Company 3: Not applicable; 
Risk predictions: Company 4: Not applicable. 

Disease or condition: Celiac disease; 
Profile: Factual; 
Risk predictions: Company 1: Elevated and typical (research); 
Risk predictions: Company 2: Average; 
Risk predictions: Company 3: Not tested; 
Risk predictions: Company 4: Higher risk than most people. 

Disease or condition: Celiac disease; 
Profile: Fictitious; 
Risk predictions: Company 1: Elevated and typical (research); 
Risk predictions: Company 2: Average; 
Risk predictions: Company 3: Not tested; 
Risk predictions: Company 4: Higher risk than most people. 

Disease or condition: Colon cancer; 
Profile: Factual; 
Risk predictions: Company 1: Elevated; 
Risk predictions: Company 2: Average; 
Risk predictions: Company 3: Increased susceptibility; 
Risk predictions: Company 4: Above average. 

Disease or condition: Colon cancer; 
Profile: Fictitious; 
Risk predictions: Company 1: Elevated; 
Risk predictions: Company 2: Average; 
Risk predictions: Company 3: Increased susceptibility; 
Risk predictions: Company 4: Above average. 

Disease or condition: Heart attack; 
Profile: Factual; 
Risk predictions: Company 1: Typical; 
Risk predictions: Company 2: Average; 
Risk predictions: Company 3: Increased susceptibility; 
Risk predictions: Company 4: Average. 

Disease or condition: Heart attack; 
Profile: Fictitious; 
Risk predictions: Company 1: Typical; 
Risk predictions: Company 2: Average; 
Risk predictions: Company 3: Increased susceptibility; 
Risk predictions: Company 4: Average. 

Disease or condition: Hypertension; 
Profile: Factual; 
Risk predictions: Company 1: Elevated (research); 
Risk predictions: Company 2: Average; 
Risk predictions: Company 3: Average predisposition; 
Risk predictions: Company 4: Not tested. 

Disease or condition: Hypertension; 
Profile: Fictitious; 
Risk predictions: Company 1: Elevated (research); 
Risk predictions: Company 2: Average; 
Risk predictions: Company 3: Average predisposition; 
Risk predictions: Company 4: Not tested. 

Disease or condition: Leukemia; 
Profile: Factual; 
Risk predictions: Company 1: Elevated (research); 
Risk predictions: Company 2: Average; 
Risk predictions: Company 3: Average predisposition; 
Risk predictions: Company 4: Not tested. 

Disease or condition: Leukemia; 
Profile: Fictitious; 
Risk predictions: Company 1: Elevated (research); 
Risk predictions: Company 2: Average; 
Risk predictions: Company 3: Average predisposition; 
Risk predictions: Company 4: Not tested. 

Disease or condition: Multiple sclerosis; 
Profile: Factual; 
Risk predictions: Company 1: Decreased; 
Risk predictions: Company 2: Average; 
Risk predictions: Company 3: Average predisposition; 
Risk predictions: Company 4: Below average. 

Disease or condition: Multiple sclerosis; 
Profile: Fictitious; 
Risk predictions: Company 1: Decreased; 
Risk predictions: Company 2: Average; 
Risk predictions: Company 3: Average predisposition; 
Risk predictions: Company 4: Below average. 

Disease or condition: Obesity; 
Profile: Factual; 
Risk predictions: Company 1: Typical and elevated (research); 
Risk predictions: Company 2: Average; 
Risk predictions: Company 3: Average predisposition; 
Risk predictions: Company 4: About average. 

Disease or condition: Obesity; 
Profile: Fictitious; 
Risk predictions: Company 1: Elevated and typical (research); 
Risk predictions: Company 2: Average; 
Risk predictions: Company 3: Average predisposition; 
Risk predictions: Company 4: About average. 

Disease or condition: Prostate cancer; 
Profile: Factual; 
Risk predictions: Company 1: Typical; 
Risk predictions: Company 2: Above average; 
Risk predictions: Company 3: Average predisposition; 
Risk predictions: Company 4: Greater than most men's. 

Disease or condition: Prostate cancer; 
Profile: Fictitious; 
Risk predictions: Company 1: Typical; 
Risk predictions: Company 2: Above average; 
Risk predictions: Company 3: Average predisposition; 
Risk predictions: Company 4: Greater than most men's. 

Disease or condition: Restless leg syndrome; 
Profile: Factual; 
Risk predictions: Company 1: Decreased; 
Risk predictions: Company 2: Below average; 
Risk predictions: Company 3: Not tested; 
Risk predictions: Company 4: Below average. 

Disease or condition: Restless leg syndrome; 
Profile: Fictitious; 
Risk predictions: Company 1: Decreased; 
Risk predictions: Company 2: Below average; 
Risk predictions: Company 3: Not tested; 
Risk predictions: Company 4: Below average. 

Disease or condition: Rheumatoid arthritis; 
Profile: Factual; 
Risk predictions: Company 1: Decreased; 
Risk predictions: Company 2: Below average; 
Risk predictions: Company 3: Do not show strong susceptibility; 
Risk predictions: Company 4: Below average. 

Disease or condition: Rheumatoid arthritis; 
Profile: Fictitious; 
Risk predictions: Company 1: Decreased; 
Risk predictions: Company 2: Below average; 
Risk predictions: Company 3: Do not show strong susceptibility; 
Risk predictions: Company 4: Below average. 

Disease or condition: Type 1 diabetes; 
Profile: Factual; 
Risk predictions: Company 1: Decreased; 
Risk predictions: Company 2: Average; 
Risk predictions: Company 3: Do not show strong susceptibility; 
Risk predictions: Company 4: Not tested. 

Disease or condition: Type 1 diabetes; 
Profile: Fictitious; 
Risk predictions: Company 1: Decreased; 
Risk predictions: Company 2: Average; 
Risk predictions: Company 3: Do not show strong susceptibility; 
Risk predictions: Company 4: Not tested. 

Disease or condition: Type 2 diabetes; 
Profile: Factual; 
Risk predictions: Company 1: Typical; 
Risk predictions: Company 2: Average; 
Risk predictions: Company 3: Average predisposition; 
Risk predictions: Company 4: About average. 

Disease or condition: Type 2 diabetes; 
Profile: Fictitious; 
Risk predictions: Company 1: Typical; 
Risk predictions: Company 2: Average; 
Risk predictions: Company 3: Average predisposition; 
Risk predictions: Company 4: About average. 

Source: GAO analysis of results from four companies. 

[End of table] 

Donor 5: Donor 5 is a 63-year-old Caucasian male who eats a balanced 
diet and exercises. He has elevated cholesterol and blood sugar. The 
donor suffers from type 2diabetes and is obese. He also has a family 
history of Alzheimer's disease. In Donor 5's fictitious profile, he is 
a 29-year-old Hispanic male who chews tobacco and suffers from asthma. 
However, he has no family history of diabetes or Alzheimer's disease. 

Table 7: Comparison of Test Results for Donor 5: 

Disease or condition: Alzheimer's disease; 
Profile: Factual; 
Risk predictions: Company 1: Not tested; 
Risk predictions: Company 2: Above average; 
Risk predictions: Company 3: Genetic markers are highly correlated 
with this disease; 
Risk predictions: Company 4: Above average. 

Disease or condition: Alzheimer's disease; 
Profile: Fictitious; 
Risk predictions: Company 1: Not tested; 
Risk predictions: Company 2: Above average; 
Risk predictions: Company 3: Genetic markers are highly correlated 
with this disease; 
Risk predictions: Company 4: Above average. 

Disease or condition: Atrial fibrillation; 
Profile: Factual; 
Risk predictions: Company 1: Typical and decreased (research); 
Risk predictions: Company 2: Below average; 
Risk predictions: Company 3: Average predisposition; 
Risk predictions: Company 4: About average. 

Disease or condition: Atrial fibrillation; 
Profile: Fictitious; 
Risk predictions: Company 1: Typical and decreased (research); 
Risk predictions: Company 2: Average; 
Risk predictions: Company 3: Average predisposition; 
Risk predictions: Company 4: About average. 

Disease or condition: Breast cancer; 
Profile: Factual; 
Risk predictions: Company 1: Not applicable; 
Risk predictions: Company 2: Not applicable; 
Risk predictions: Company 3: Not applicable; 
Risk predictions: Company 4: Not applicable. 

Disease or condition: Breast cancer; 
Profile: Fictitious; 
Risk predictions: Company 1: Not applicable; 
Risk predictions: Company 2: Not applicable; 
Risk predictions: Company 3: Not applicable; 
Risk predictions: Company 4: Not applicable. 

Disease or condition: Celiac disease; 
Profile: Factual; 
Risk predictions: Company 1: Elevated and decreased (research); 
Risk predictions: Company 2: Above average; 
Risk predictions: Company 3: Not tested; 
Risk predictions: Company 4: Higher risk than most people. 

Disease or condition: Celiac disease; 
Profile: Fictitious; 
Risk predictions: Company 1: Elevated and decreased (research ); 
Risk predictions: Company 2: Above average; 
Risk predictions: Company 3: Noted tested; 
Risk predictions: Company 4: Higher risk than most people. 

Disease or condition: Colon cancer; 
Profile: Factual; 
Risk predictions: Company 1: Decreased; 
Risk predictions: Company 2: Average; 
Risk predictions: Company 3: Average predisposition; 
Risk predictions: Company 4: Average. 

Disease or condition: Colon cancer; 
Profile: Fictitious; 
Risk predictions: Company 1: Decreased; 
Risk predictions: Company 2: Average; 
Risk predictions: Company 3: Average predisposition; 
Risk predictions: Company 4: Average. 

Disease or condition: Heart attack; 
Profile: Factual; 
Risk predictions: Company 1: Typical; 
Risk predictions: Company 2: Above average; 
Risk predictions: Company 3: Increased susceptibility; 
Risk predictions: Company 4: Average. 

Disease or condition: Heart attack; 
Profile: Fictitious; 
Risk predictions: Company 1: Typical; 
Risk predictions: Company 2: Above average; 
Risk predictions: Company 3: Increased susceptibility; 
Risk predictions: Company 4: Average. 

Disease or condition: Hypertension; 
Profile: Factual; 
Risk predictions: Company 1: Elevated (research); 
Risk predictions: Company 2: Average; 
Risk predictions: Company 3: Average predisposition; 
Risk predictions: Company 4: Not tested. 

Disease or condition: Hypertension; 
Profile: Fictitious; 
Risk predictions: Company 1: Elevated (research); 
Risk predictions: Company 2: Average; 
Risk predictions: Company 3: Average predisposition; 
Risk predictions: Company 4: Not tested. 

Disease or condition: Leukemia; 
Profile: Factual; 
Risk predictions: Company 1: Elevated (research); 
Risk predictions: Company 2: Average; 
Risk predictions: Company 3: Average predisposition; 
Risk predictions: Company 4: Not tested. 

Disease or condition: Leukemia; 
Profile: Fictitious; 
Risk predictions: Company 1: Elevated (research); 
Risk predictions: Company 2: Average; 
Risk predictions: Company 3: Average predisposition; 
Risk predictions: Company 4: Not tested. 

Disease or condition: Multiple sclerosis; 
Profile: Factual; 
Risk predictions: Company 1: Decreased; 
Risk predictions: Company 2: Average; 
Risk predictions: Company 3: Average predisposition; 
Risk predictions: Company 4: Below average. 

Disease or condition: Multiple sclerosis; 
Profile: Fictitious; 
Risk predictions: Company 1: Decreased; 
Risk predictions: Company 2: Average; 
Risk predictions: Company 3: Average predisposition; 
Risk predictions: Company 4: Below average. 

Disease or condition: Obesity; 
Profile: Factual; 
Risk predictions: Company 1: Typical and typical (research); 
Risk predictions: Company 2: Average; 
Risk predictions: Company 3: Average predisposition; 
Risk predictions: Company 4: About average. 

Disease or condition: Obesity; 
Profile: Prostate cancer: Fictitious; 
Risk predictions: Company 1: Typical and typical (research); 
Risk predictions: Company 2: Average; 
Risk predictions: Company 3: Average predisposition; 
Risk predictions: Company 4: About average. 

Disease or condition: Prostate cancer; 
Profile: Factual; 
Risk predictions: Company 1: Typical; 
Risk predictions: Company 2: Average; 
Risk predictions: Company 3: Average predisposition; 
Risk predictions: Company 4: Average. 

Disease or condition: Prostate cancer; 
Profile: Fictitious; 
Risk predictions: Company 1: Typical; 
Risk predictions: Company 2: Average; 
Risk predictions: Company 3: Average predisposition; 
Risk predictions: Company 4: Average. 

Disease or condition: Restless leg syndrome; 
Profile: Factual; 
Risk predictions: Company 1: Decreased; 
Risk predictions: Company 2: Above average; 
Risk predictions: Company 3: Not tested; 
Risk predictions: Company 4: Higher than most people. 

Disease or condition: Restless leg syndrome; 
Profile: Fictitious; 
Risk predictions: Company 1: Decreased; 
Risk predictions: Company 2: Above average; 
Risk predictions: Company 3: Not tested; 
Risk predictions: Company 4: Higher than most people. 

Disease or condition: Rheumatoid arthritis; 
Profile: Factual; 
Risk predictions: Company 1: Decreased; 
Risk predictions: Company 2: Below average; 
Risk predictions: Company 3: Do not show strong susceptibility; 
Risk predictions: Company 4: Below average. 

Disease or condition: Rheumatoid arthritis; 
Profile: Fictitious; 
Risk predictions: Company 1: Typical; 
Risk predictions: Company 2: Below average; 
Risk predictions: Company 3: Do not show strong susceptibility; 
Risk predictions: Company 4: Below average. 

Disease or condition: Type 1 diabetes; 
Profile: Factual; 
Risk predictions: Company 1: Elevated; 
Risk predictions: Company 2: Average; 
Risk predictions: Company 3: Average predisposition; 
Risk predictions: Company 4: Not tested. 

Disease or condition: Type 1 diabetes; 
Profile: Fictitious; 
Risk predictions: Company 1: Elevated; 
Risk predictions: Company 2: Average; 
Risk predictions: Company 3: Average predisposition; 
Risk predictions: Company 4: Not tested. 

Disease or condition: Type 2 diabetes; 
Profile: Factual; 
Risk predictions: Company 1: Typical; 
Risk predictions: Company 2: Average; 
Risk predictions: Company 3: Average predisposition; 
Risk predictions: Company 4: Above average. 

Disease or condition: Type 2 diabetes; 
Profile: Fictitious; 
Risk predictions: Company 1: Elevated; 
Risk predictions: Company 2: Average; 
Risk predictions: Company 3: Average predisposition; 
Risk predictions: Company 4: Above average. 

Source: GAO analysis of results from four companies. 

[End of table] 

[End of section] 

Footnotes: 

[1] GAO, Nutrigenetic Testing: Tests Purchased from Four Web Sites 
Mislead Consumers, GAO-06-977T (Washington D.C.: July 27, 2006). 

[2] The companies are not the same as the companies tested in our 2006 
investigation. 

[3] The companies also provided consumers with ancestry reports; drug 
response tests; and predictions for various traits and 
characteristics, such as eye color. We focused our investigation on 
testing the companies' disease risk predictions. 

[4] Type 1 diabetes is usually first diagnosed in children, teenagers, 
or young adults. With this form of diabetes, the cells of the pancreas 
no longer make insulin because the body's immune system has attacked 
and destroyed them. Type 2 diabetes is the most common form of 
diabetes. People can develop type 2 diabetes at any age--even during 
childhood. This form of diabetes usually begins with insulin 
resistance, a condition in which fat, muscle, and liver cells do not 
use insulin properly. 

[5] In a "research" report contained in the test results, Company 1 
also found this donor to be at below-average risk for atrial 
fibrillation. These conflicting reports will be discussed later in the 
testimony. 

[6] Pauline C. Ng, Sarah S. Murray, Samuel Levy, and Craig J. Venture, 
An Agenda for Personalized Medicine, Nature, vol. 461, October 8, 2009. 

[7] Company 3 is the only company that asked consumers to provide 
medical history information as part of the DNA submission process. 

[8] In another report contained in the test results, Company 1 also 
found this donor to be at average risk for atrial fibrillation. These 
conflicting reports will be discussed later in the testimony. 

[9] In our post-test interviews, Company 1 told us that it is in the 
process of entering into an agreement with a genetic counseling 
provider service to which the company will refer interested customers. 

[10] An allele is one member of a pair or series of genes that occupy 
a specific position on a specific chromosome. 

[End of section] 

GAO's Mission: 

The Government Accountability Office, the audit, evaluation and 
investigative arm of Congress, exists to support Congress in meeting 
its constitutional responsibilities and to help improve the performance 
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