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A new test claims it can determine fetal gender as early as five weeks into pregnancy. Doctors are skeptical.
Ric Feld / AP
Midlife-Changes Health Questions
Oct. 17, 2005 issue - Maria Forero, 28, was pregnant with her first child when she saw a TV report about Baby Gender Mentor, a new test that claimed to identify the sex of a fetus just five weeks into the pregnancy. Curious, she bought the product online for $25, did the necessary finger pricking and sent her blood sample—along with a $250 fee—for analysis at Acu-Gen Biolab, Inc, the Massachusetts-based lab that makes the test.
Forero is not alone in her curiosity. According to Sherry Bonelli, president of pregnancystore.com, the exclusive retailer of the at-home test, "several thousand" expectant women have bought the product. Doctors, however, are skeptical about Acu-Gen's claim of a 99.9 percent accuracy rate in predicting the gender of babies based in part on fetal DNA extracted from the mother's blood. "The real question for consumers is, how can you know if a test is valid and if the lab is reliable?" asks Kathy Hudson, director of the Johns Hopkins Genetics and Public Policy Center. In the case of the Baby Gender Mentor test, she says, there is not enough information to know the answer. Nor do sales of the test—marketed since 2004—require approval from the Food and Drug Administration.
Dr. Diana Bianchi, a prenatal geneticist at the Tufts University School of Medicine who has been conducting research in this area for 20 years, also says she wants to see scientific proof of the test's validity. Acu-Gen claims on the pregnancystore Web site that its technology has accurately predicted the gender of 20,000 babies in a 14-year trial. However, it offers no details of the trial nor indicates if or where the findings were published. In the site's "science and validation" section, the company lists five related studies on fetal DNA that appear to have been conducted by researchers in China, Russia, and the United Kingdom among other places, but no information on where viewers can access the full results of those trials.
Asked for comment, Acu-Gen president C.N. Wang said that the research had not been conducted in any of the countries mentioned. "The accuracy is based on correlation studies between two technology platforms with validated data from actual births spanning more than a decade," he told NEWSWEEK in an e.mailed response. Wang also said that the manuscripts for the technology were "in preparation" for publication for peer-reviewed journals.
Wang notes that the test does not determine gender solely by searching for fetal DNA in the mother's blood. "The gender of the fetus is determined and verified by the presence of a host of `active' genetic materials derived specifically from the female and male fetuses during implantation," he says. "It is not limited to DNA only and if our biomarkers are targeting DNA for some instances, it is only specific to certain forms of DNA molecules adopting certain conformations only."
Bianchi says that in her own studies, including one in which blood samples from 20 pregnant women were each sent to five different labs and tested for gender, the results varied. "We will probably see a new generation of tests based on this [fetal DNA] information but that is still a number of years away," she says.
The Baby Gender Mentor test has a number of unsatisfied customers too: some parents-to-be have complained on some online forums that Acu-Gen predicted the wrong gender for their unborn child. Bonelli claims that some of the complaints are from women who haven't given birth yet and their proof that Acu-Gen incorrectly predicted the gender of their unborn child is an ultrasound. Bonelli's argument: that "about 10 to 20 percent of ultrasound readings will incorrectly identify the baby gender." So she figures that for every 1,000 Baby Gender Mentor tests, nearly 100 women will have conflicting ultrasound readings. Acu-Gen says it stands by its tests by offering a 200-percent refund to parents who later learn that the gender test was wrong. So far four such checks have been issued, says Wang, including one for a case involving a vanishing twin.
Some doctors are also concerned that learning the gender so early may prompt some parents to end the pregnancy if they were hoping for a baby of the opposite sex. Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania, said that while this is not a major a problem in the United States, it is a concern in countries like India or China, where boys are favored over girls. Bonelli says that the site will not accept orders from countries outside the United States, but there is no indication on the Web site that this is the case. Wang insists his company does not allow service to countries with "gender biased birth" policies.
Though more parents are opting to learn the gender of their babies while they're still in the womb, prenatal testing is still primarily done to assess the health of the fetus and check for signs of developmental problems or birth defects. Although some tests can determine fetal gender during the first trimester, these procedures tend to involve more complex invasive procedures that have to be carried out by qualified personnel. Gender identification is a by-product of the tests, not the primary purpose. Caplan says testing is appropriate when doctors are looking for a lethal or disabling diseases, but it becomes controversial when testing for mild to moderately disabling diseases, and even more controversial when testing for risk factors for diseases . Most doctors, he adds, draw the line at gender testing.
Still, Forero says she has no regrets about taking the test so early. When she got the email from Acu-Gen informing her that her results were available, she called her husband at work and they read together that predictions from her family and friends were right—she was carrying a boy. Her doctor confirmed this during a routine 20-week ultrasound. "We're really happy," she says. By the time she got the confirmation from her doctor, Forero already had a few blue baby outfits. She'd bought them the day she got her lab results back from Acu-Gen.
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