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Baby Gender Mentor: A Suit Is Born

March 23rd, 2006 Nicholas Genes Diagnostics, Ob/Gyn, Reproductive Medicine

hula hoops, indeed
A blood test to detect the gender of your baby, even at five weeks gestation? We blogged about the Baby Gender Mentor last summer, and have been hearing about it ever since — in the form of critical comments and emails. It seems we weren’t the only ones getting an earful — the company that makes this product, Acu-Gen, and the online site sellling it, PregnancyStore — are both being sued:

In a class action lawsuit filed in the US district court in Boston on behalf of 16 women the makers of the Baby Gender Mentor are accused of breaking their promise. Barry Gainey, the women’s lawyer, said he knew of about 100 women whom the kit had failed, including some from Britain who bought it online.
The suit seeks to bar Acu-Gen Biolab from falsely marketing its test and to compel the firm to honour its money-back guarantee. The Baby Gender Mentor’s website promises “unsurpassed accuracy” in predicting the sex of a foetus from three drops of a pregnant woman’s blood, allowing parents to form a “natural nexus with your baby early on”.
The test, which costs $275 (£156), claims to detect foetal chromosomes in the maternal blood stream. Women do it at home and send it to Massachusetts for processing. They are promised double their money back on production of a birth certificate if the result is wrong.
But within weeks of taking the test dozens of pregnant women reported having ultrasound scans showing they were having babies of the opposite gender…
“If he sold 4,000 tests he has got a right to have four women get it wrong, but he is way over that number,” Mr Gainey said.

More worrisome is this report that the Baby Gender Mentor’s founder was denying refunds and suggesting that inaccurate results implied fetal genetic defects.
Acu-Gen never claimed to be be making a “medical diagnosis” — meaning no healthcare decisions should be made with the information their test provides. But if one of these dozens of moms suing had abortion because of faulty information (either for sex selection or to avoid sex-linked disease) we wonder if they would have a six-figure case.
Determining fetal gender isn’t just for parents who want to pick out wallpaper for the nursery before ultrasound is an option. With sex-linked diseases, knowing the gender means preparing for (or avoiding) a difficult pregnancy or infancy (patterns of free-floating fetal DNA can be a marker for pre-eclampsia, to say nothing of allowing for noninvasive genetic screening of the fetus — OB-GYN’s and geneticists have access to, shall we say, more validated means of determining gender noninvasively, such as this technique described in 2001).
The Baby Gender Mentor site is mum on their validation method, other than saying they’ve got 14 years of data (which, we think, pre-dates the discovery of cell-free fetal DNA circulating in maternal blood).
We’ll be following this trial and the science behind it in the months ahead. In the meantime, the test kit is still available at the Pregnancy Store for $275, claiming a 200% money back guarantee…

Nicholas Genes

Nicholas Genes, MD, PhD, has been with Medgadget since almost the beginning. He's now Assistant Professor of Emergency Medicine at Mount Sinai, where in addition to patient care and teaching responsibilities, he studies EHR usability and physician uses of social media. Dr. Genes serves on the editorial boards of Emergency Physicians Monthly and Emergency Medicine Practice. More about Nick: http://nickgenes.com

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