by Lori Andrews

On-line genetic testing companies offer to provide people with information regarding their family tree; their relative chances of developing a disease, condition, or trait; their nutritional profile; and their response to a particular drug.  For example, at HairDX, individuals can be tested for a susceptibility to hair loss, or their response to a particular hair loss prevention aid.  If a customer wishes to learn whether his Y-chromosome shares any similarity with the Jefferson Y-chromosome, he can visit FamilyTreeDNA.com.

Initially, the testing focused on illness and ancestry.  But now companies are reaching out to pregnant women with promises to predict the sex of their child.  The pregnant woman pricks her finger, then collects three drops of blood on a test card and sends it to the company for testing.  For $275, Acu-Gen Biolab, Inc. offers pregnant women such a test which analyzes fetal cells circulating in maternal blood to make the assessment.

The company claims that their Baby Gender Mentor Test is “highly accurate.”  However, the lawyer for a group of women suing Acu-Gen Biolab alleges that the company officials admit that 10 to 20 percent of customers have asked for refunds because of incorrect results.

In addition to a class action for fraud filed in 2007, mothers in New York filed suit last month charging negligence and fraud against Acu-gen.  One of the plaintiffs underwent testing because she wanted a boy and Acu-gen allegedly told her she would have a boy.  She didn’t, and she blames the company for her marriage breaking up.

Most opponents of these direct-to-consumer genetic tests do not suggest that a person should not have any access to his or her genetic information, but rather that access should be in the context of a dialogue with a health care professional who can accurately provide “advice about the suitability of the test and its potential implications, expert interpretation of the test results, and guidance about actions to take as a consequence.”  Moreover, such genetic tests create a substantial risk of misleading consumers to take inappropriate healthcare decisions, are often based on questionable correlations or conflicting reports, and can cause increased anxiety and unnecessary medical procedures if test results are misinterpreted.

Some of the women who have used on-line genetic testing for fetal sex and had the sex misdiagnosed allege that they were told by the company not that the test was inaccurate but that their fetus was abnormal.  The distraught mothers then sought costly chromosomal testing through the medical system to find the source of this “abnormality.”

As the number of on-line genetic testing companies grows, with companies testing for as many as 800 different diseases and conditions at a time, the chances for mistakes and misleading results are increasing.  People who use on-line, direct-to-consumer testing should keep in mind a warning from the Federal Trade Commission:  “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 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.”

And being told during pregnancy that your girl is a boy or vice versa does not mean that there is something wrong with your child.  Instead, there is likely to be something wrong with the test.