Gender test questioned by more parents

The uproar about Acu-Gen’s Baby Gender Mentor continues. The test—advertised on the provider’s website as a “NEW Baby Gender Mentor Home DNA Gender Testing Kit”—is presumably based upon identifying a Y-chromosome in fetal-specific DNA obtained from a few dried drops of mother’s blood. If there’s a Y, the baby’s a boy; if there’s no Y, the baby’s a girl; if you’ve told them ahead of time you’re expecting twins, they can tell you whether you have one baby of each sex. The other possible options are not described in the publicity.

The provider claims 99.9% accuracy—comparing their test to their claim for 80% accuracy of sonograms—and guarantees a 200% refund [if you meet certain requirements]. Yes, I intended the print of that text to be smaller.

So, what’s the problem?  Increasing numbers of mothers are claiming that the test inaccurately predicted the gender of their infants—but not all these infants have been born yet, and the provider of the test states that ultrasound is not sufficiently accurate to challenge their test. So, no one knows whether any refunds have been made or whether any of the "errors" have had serious ramifications. 

According to the Science Magazine article that the provider claims provides the proof that the test works, “Food and Drug Administration approval is not needed as long as the blood sample goes to a lab and the test is sold as a service rather than as a kit. The provider’s website interchanges the words test and kit quite frequently; however, because the actual testing is not done by the person who supplies the blood (as for example with a pregnancy test kit or the at-home HIV-testing kit), the conclusion that this is a test, not a kit, is probably appropriate.

Meanwhile, a Canadian company has been offering a fetal DNA gender test for more than 2 years. Their marketing is low-key, however, and the test uses fresh blood from a woman 10 or more weeks pregnant—not the dried blood from a woman 5 or more weeks pregnant.  

If the only risk were incorrectly buying the “wrong” gender clothing, maybe we could just say, “buyer beware”. We can only pray that no one considers terminating a pregnancy based on this gender test. Meanwhile, according to National Public Radio a couple of months ago, "customers and scientists are raising questions about the accuracy of the widely publicized genetic test; customers have complained to the Federal Trade Commission, and at least one law enforcement agency is investigating a company that sells the test."

You can see the Science article at http://www.pregnancystore.com/images/Baby%20Gender/Science%20Magazine.pdf and listen to the NPR report at http://www.npr.org/templates/story/story.php?storyId=4952404.

Marie Godfrey, PhD

Submitted by Genetizen on Tue, 01/10/2006 - 11:07pm. Blog Entry | Genetic testing

Here come the lawyers--Baby Gender Mentor

I worked for pharmaceutical companies for many years and was always focused on patient safety. One indication I now use that a product is in trouble is when I start seeing law-firm ads on the t.v. In this case, the product is Baby Gendor Mentor--described earlier in this Genetizen blog.

The test is sold through ads in pregnancy and baby magazines and over the Internet and is supposed to tell an expectant mother the gender of her developing child as early as 5 weeks. The mother supplies a few drops of blood and the test says, congratulations you are expecting a ......!

Last fall, there were news items that the results were being questioned by a number of people. Recently, questions related to the test have again arisen. News programs that earlier contacted BABY Gender Mentor and Accu-Gen, the source of the test, were told to wait until babies had been born and see whether the test or a conflicting ultrasound was right in each case. The company claims 99.9% accuracy, but refuses to release any data. Now, some of those babies have been born. Again, though, there's no unbiased collection of wrong vs. right predictions.

What we have learned, is that a lawsuit has been filed by some mothers in New Jersey--the number of plaintiffs varies depending on the source you read. Here's the webpage for the lawsuit: http://www.babygenderinvestigation.com/ . As with any group seeking validation, the group is looking for people to add to the list of disgruntled purchasers.

Both ABC (http://www.abcactionnews.com/stories/2006/02/060220babyfolo.shtml)  and NPR (http://www.npr.org/templates/story/story.php?storyId=5235003) have recently aired reports. A website called in-gender.org (http://www.in-gender.com/cs/blogs/gender_selection_news/archive/2006/2/17/6646.aspx) has been following this and other gender identification issues for some time.

I'm sure there's more to come.

Marie Godfrey, PhD