FTC FACTS for Consumers

FOR THE CONSUMER 1-877-FTC-HELP

ftc.gov FEDERAL TRADE COMMISSION

At-Home Genetic Tests:

A Healthy Dose of Skepticism 

May Be the Best Prescription

C ould a simple medical test tell you if you are likely to get a particular disease? Could it evaluate your health risks and even suggest a specific 

treatment? Could you take this test in the privacy of your home, without a doctor’s 

prescription or guidance?

Some companies say genetic testing can do all this and more. They claim that at-home 

genetic testing can screen for diseases and provide a basis for choosing a particular 

diet, dietary supplement, lifestyle change, or medication. They sell their tests in 

supermarkets and drugstores, and they advertise their services in print, on television, 

and online.

The Federal Trade Commission (FTC) wants you to know the facts about the 

direct-to-consumers marketing of genetic tests. According to the Food and Drug 

Administration (FDA), which regulates the manufacturers of genetic tests; and the 

Centers for Disease Control and Prevention (CDC), which promotes health and 

quality of life, some of these tests lack scientific validity, and others provide medical 

results that are meaningful only in the context of a full medical evaluation. The 

FDA and CDC say that because of the complexities involved in both the testing and 

the interpretation of the results, genetic tests should be performed in a specialized 

laboratory, and the results should be interpreted by a doctor or trained counselor who 

understands the value of genetic testing for a particular situation. 
Facts for Consumers 

Genes and Genetic Tests

Inside the cells of your body, chromosomes 

carry your genetic blueprint. Your 

chromosomes, which are passed to you 

by your parents, contain genes made of 

DNA (deoxyribonucleic acid). Your genes 

determine characteristics like eye color or 

height, and contribute to your chances of 

getting certain diseases. 

Genetic tests examine genes and DNA to 

see if they indicate particular diseases or 

disorders. Several different types of tests are 

available. Some look at the number and shape 

of chromosomes to see if there are obvious 

abnormalities. Others look for small unusual 

portions of individual proteins or sections of 

DNA. Typically, these tests require a blood 

sample or a swab from inside the cheek. In 

“at-home” tests, the sample is collected at 

your home and then sent to a laboratory for 

analysis. Prices of at-home genetic tests range 

from $295 to $1200. 

Interpreting Test Results

The results of genetic tests are not always 

“black and white.” That makes interpretations 

and explanations difficult. In most cases, 

diseases occur as a result of interaction 

between our genes and the environment 

— for example, our lifestyle, foods we eat, 

elements we are exposed to such as sunlight, 

and tobacco. The interaction between these 

factors in contributing to health and disease 

can be very complicated. Even health care 

experts are just beginning to understand these 

issues. That’s why it is important to gather 

and analyze this information with a qualified 

healthcare provider so you can be sure genetic 

data is accurate and correctly used.

Most genetic tests look at only a small number 

of the more than 20,000 genes in the human 

body. A positive result means that the testing 

laboratory found unusual characteristics or 

changes in the genes it tested. Depending on 

the purpose of the test, a positive result may 

confirm a diagnosis, identify an increased 

risk of developing a disease, or indicate that a 

person is a carrier for a particular disease. It 

does not necessarily mean that a disease will 

develop, or if it does, that the disease will be 

progressive or severe.

A negative result means that the laboratory 

found no unusual characteristics or changes 

in the genes it tested. This could mean that 

a person doesn’t have a particular disease, 

doesn’t have an increased risk of developing 

the disease, or isn’t a carrier of the disease. 

Or it could mean that the test missed the 

specific genetic changes associated with a 

particular disease. 

In short, the FDA and CDC say that genetic 

testing provides only one piece of information 

about a person’s susceptibility to disease. 

Other factors, like family background, 

medical history, and environment also 

contribute to the likelihood of getting a 

particular disease. In most cases, genetic 

testing makes the most sense when it is part 

of a physical exam that includes a patient’s 

family background and medical history. 

Company Claims

Be wary of claims about the benefits these 

products supposedly offer. Some companies 

claim that at-home genetic tests can measure 

the risk of developing a particular disease, 

like heart disease, diabetes, cancer, or 

Alzheimer’s. But the FDA and CDC say they 
Facts for Consumers

aren’t aware of any valid studies that prove 

these tests give accurate results. Having a 

particular gene doesn’t necessarily mean that 

a disease will develop; not having a particular 

gene doesn’t necessarily mean that the disease 

will not.

Some companies also may claim that a person 

can protect against serious disease by choosing 

special foods and nutritional supplements. 

Consequently, the results of their at-home 

tests often include dietary advice and sales 

offers for “customized” dietary supplements. 

But the advice rarely goes beyond standard 

sensible dietary recommendations. The FDA 

and CDC say they know of no valid scientific 

studies showing that genetic tests can be used 

safely or effectively to recommend nutritional 

choices. 

Be skeptical of claims that the tests can 

assess a person’s ability to withstand certain 

environmental exposures, like particular 

toxins or cigarette smoke. The FDA and CDC 

aren’t aware of any valid scientific studies that 

show that genetic tests can be used to predict 

whether a person can withstand environmental 

exposures.

Recently, some companies have claimed 

their at-home tests can give information 

about how a person’s body will respond to 

a certain treatment, and how well people 

will respond to a particular drug. This claim 

is based on current medical research that 

shows differences in drug effectiveness 

based on genetic make-up. But, say federal 

experts, while these tests may provide some 

information your doctor needs or uses to make 

treatment decisions for a specific condition, 

they are not a substitute for a physician’s 

judgment and clinical experience.

If You’re Considering

an At-Home Genetic Test

According to the FDA and CDC, at-home 

genetic tests aren’t a suitable substitute 

for a traditional healthcare evaluation. 

Medical exams that include conventional 

laboratory tests like blood chemistry and 

lipid profiles are a more appropriate starting 

point for diagnosing diseases and assessing 

preventive measures. Nevertheless, if you are 

considering using an at-home genetic test: 

• Talk to your doctor or healthcare 

practitioner about whether it might 

provide useful information about your 

health, and if so, which test would be 

best. Make sure you understand the 

benefits and limits of any test before you 

buy it — or take it. 

• Ask your doctor or a genetic counselor 

to help you understand your test results. 

Most companies that sell at-home genetic 

tests do not interpret the results.

• Discuss the results of your test with your 

doctor or healthcare practitioner before 

making dietary or other health-related 

decisions. Genetic test results can be 

complex and serious. You don’t want to 

make any decisions based on incomplete, 

inaccurate, or misunderstood information. 

• Protect your privacy. At-home test 

companies may post patient test results 

online. If the website is not secure, 

your information may be seen by 

others. Before you do business with any 

company online, check the privacy policy 

to see how they may use your personal 

information, and whether they share 

customer information with marketers. 

• While most other home-use medical 

tests undergo FDA review to provide a 

reasonable assurance of their safety and 
Facts for Consumers

1-877-FTC-HELP FOR THE CONSUMER

FEDERAL TRADE COMMISSION ftc.gov

July 2006

Federal Trade Commission

Bureau of Consumer Protection

Division of Consumer and Business Education

effectiveness, no at-home genetic tests 

have been reviewed by the FDA, and the 

FDA has not evaluated the accuracy of 

their claims. 

For More Information

The Federal Trade Commission works 

for the consumer to prevent fraudulent, 

deceptive, and unfair business practices in 

the marketplace and to provide information to 

help consumers spot, stop, and avoid them. 

To file a complaint or to get free information 

on consumer issues, visit ftc.gov or call tollfree, 1-877-FTC-HELP (1-877-382-4357); 

TTY: 1-866-653-4261. 

The Food and Drug Administration is 

responsible for protecting the public health 

by assuring the safety, efficacy, and security 

of human and veterinary drugs, biological 

products, medical devices, our nation’s 

food supply, cosmetics, and products that 

emit radiation. The FDA also is responsible 

for advancing the public health by helping 

to speed innovations that make medicines 

and foods more effective, safer, and more 

affordable; and helping the public get the 

accurate, science-based information they 

need to use medicines and foods to improve 

their health. For more information from the 

FDA, call toll-free 1-800-INFO-FDA. Copies 

of press releases and consumer alerts are 

available from FDA’s website at www.fda.gov.

The Centers for Disease Control and 

Prevention is one of the 13 major operating 

components of the Department of Health 

and Human Services, which is the principal 

agency in the United States government 

for protecting the health and safety of all 

Americans and for providing essential human 

services, especially for those people who are 

least able to help themselves. For further 

information about CDC, call toll-free 

1-800-CDC-INFO or e-mail cdcinfo@cdc.gov.

Produced in cooperation with the Food and Drug Administration (FDA) 

and the Centers for Disease Control and Prevention (CDC)