Baby Gender Mentor
Baby Gender Mentor is the trade name of a controversial blood test designed for prenatal sex discernment. The test was manufactured by Acu-Gen Biolab, Inc., a biotech company in Lowell, Massachusetts, United States. The test made a media debut on 17 June 2005 on The Today Show and it was featured in Newsweek in October 2005. About 4,500 people had purchased the test by March 2006.
The test claimed that it offered an alternative to amniocentesis and ultrasound. Gender Mentor claimed that women had many motivations for using the test to learn the sex of their fetuses early in pregnancy, including mental preparation and planning gender-specific purchases, or more controversially, sex-selective abortion.
Customers and scientists have questioned the accuracy of the test. Legal actions were taken against Acu-Gen and their supplier. The lawsuits claimed that Acu-Gen's products do not accurately predict the sex of the baby. In their defense, Acu-Gen stated that ultrasound prediction of the sex of a fetus is not always accurate, and told one family their baby had gender abnormalities.
Women were instructed to prick their finger to draw a small amount of blood, which was placed on a card to be sent to Acu-Gen to be analyzed for US$250. The kit did not require regulation since it did not diagnose, prevent or treat a disease. The company was not obliged to disclose results of tests.
Acu-Gen listed studies related to detecting fetal blood cells present in maternal circulation, but studies did not refer specifically to the Baby Gender Mentor test. The company claimed that their kit could detect twins.
Initial media attention
The test was featured on an episode of The Today Show in June 2005. In that show, Katie Couric interviewed a woman named Holly Osburn who was mother to two daughters and expecting. Osborn said that she wanted to know the gender because she wanted to paint the nursery blue. Sherry Bonelli, the CEO of PregnancyStore.com was also interviewed and said that the test had only been available for two weeks and that numerous people had inquired about it in a short time. She also said that Acu-Gen had followed 2,000 pregnancies through to birth and that the lab results given by the Baby Gender Mentor had never been wrong. The Gender Mentor Test used qPCR technology to determine the gender of the baby. It was the first product of its kind to enter the market, despite the fact that many companies had been attempting to develop similar technologies for years. This caused frustration among competitors who had invested significant time and resources into the development of their own gender-determining products. Gender Mentor claimed to have been used in 20,000 pregnancies. On the show, the results of Osborn's test revealed that was going to have another girl.During the same segment of The Today Show, Couric interviewed Dr. Ronald Wapner, head of maternal fetal medicine at NewYork–Presbyterian Hospital, he discussed possible pros and cons of the test. His first concern was whether the stated accuracy rate achieved in the 2,000 test cases would be realized in real world usage. His second concern was whether couples who purchase the test might use the results for family balancing, which means the decision to utilize selective abortion to achieve a baby of the desired sex. Wapner said that one positive aspect of the Baby Gender Mentor test is the non-invasive nature of the test, which means there should be no risk of harm to the fetus.
The test was listed as one of the top 10 innovations of 2005 by research company Datamonitor. In their report, titled Build A Better Mousetrap, Datamonitor identifies their picks for "the best new food, drink, health, household and pet products of 2005". They listed the test as the number 8 innovation of the year.
Accuracy of the test disputed
At least 40 women came forward to say their Baby Gender Mentor tests predicted the wrong sex. Compared to the 20,000 women the Baby Gender Mentor test was used on successfully, these 40+ “inaccurate” tests only account for 0.2% of the tests performed. According to a National Public Radio report, the company has explained certain inaccurate results as being the result of a vanishing twin, a fetus that stopped growing soon after fertilization. Acu-Gen claimed that their kit could predict a mixed sex set of fraternal twins, so the test should have predicted twins instead of predicting a single baby whose sex turned out to be incorrect.With Acu-Gen choosing not to publish proof of its claims and evidence of several women receiving inaccurate predictions, doctors are concerned about the test. Among the scientific evidence cited by Acu-Gen's website is a paper co-authored by Diana Bianchi, an expert on fetal DNA at Tufts University. The NPR story quoted Bianchi as saying, "I think at the present time we need to be concerned whether the test is accurate or not", and "I think it's caveat emptor. Let the buyer beware." Another criticism has come from Sandra Carson, professor of obstetrics and gynecology and involved in research in sex selection. Carson says, "Until Acu-Gen releases its data, there's no way to know the test's reliability. Until that's out, I think it shouldn't be on the market." Carson at that time was at the Baylor College of Medicine. Dr. Charles Lockwood, chairman of obstetrics and gynecology at Yale School of Medicine, said that it is possible for fetal DNA to be found in maternal blood as soon as the placenta has developed, and that detection after five weeks "is not impossible" and the president of Acu-Gen said the suit was "totally bogus".
There are multiple legal challenges and investigations underway. Gail O'Conner, a spokesperson for the Illinois State Attorney General, says that they are investigating PregnancyStore.com for possible fraud. No fraud charges were ever made against PregnancyStore.com.Florida Congressman Jim Davis has urged the FDA to investigate Acu-Gen, and the Florida Attorney General has opened an investigation against Acu-Gen. A law firm named Gainey & McKenna has filed a class action lawsuit and at least one other firm is inviting people to contact them about their legal rights if they are unhappy with the results of their test. Gainey & McKenna's lawsuit seeks to bar the company from false advertising in marketing its test and to compel the firm to honor its money-back guarantee. The law firm cites seven areas of contention, including the veracity of the accuracy claims and the violation of HIPAA and other laws.
Possible uses for test
Parents have cited an interest in preparing themselves or the baby's siblings for gender-specific issues. Some women might prefer this test to an ultrasound exam, which might reveal fetal abnormalities that the parents might prefer not to know about until after delivery.Concerns about sex selection
The National Public Radio investigative report on Acu-Gen predicted that parents may use the Baby Gender Mentor test as a basis for determining whether to get a sex-selective abortion. KMSP-TV interviewed genetic counselor Dr. Analia Bortz who made the same prediction. The concern is that learning the sex at such an early point may lead parents to terminate the pregnancy if they were hoping for a baby of the opposite sex to that indicated by the test. Americans United for Life argues that women disappointed by the result of their test would find it easier to have an abortion if they get the results early. They say that women who want to have a specific sex will be learning the results at a time when it is safer for them to have an abortion, without the complications associated with aborting later in pregnancy.Some bioethicists believe that sex selection is an ethical problem and could be disruptive to society. Charles Lockwood of Yale says, "a disproportionate number of female fetuses have been terminated worldwide, and a 2-to-1 male-to-female ratio could lead to social unrest and wars." According to Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania, sex selection is not a frequent occurrence in the United States but it is a concern in countries such as India and China, where having boys is preferred over having girls. In China, sex selection has led to men outnumbering women by about 105-to-100. In India, the ratio of girls to boys is also on the decline. The 2004 census shows that there were 818 girls born per 1,000 boys; the ratio varies in different parts of India, with the greatest imbalance occurring in the most affluent areas. In a certain portion of New Delhi, only 762 girls were born per 1,000 boys. Punjab's Health Minister Ramesh Chander Dogra has said he will take action to ban the test in India.
The website for the PregnancyStore.com says that they will ship the tests only within the United States, Sheila McLean, professor of medical ethics at Glasgow University, is critical of the kits.
Alleged use for medical diagnoses
Acu-Gen's website states the test was not a medical test:Tests similar to the Baby Gender Mentor test can be used for medical diagnoses. For instance, scientists have shown that it is possible to use fetal DNA from a woman's blood to screen the fetus for genetic defects such as Down syndrome. In a validation study sponsored by the National Institute for Child Health and Development, 5 different labs used fetal cells from maternal blood to search for evidence of Down syndrome in 2,744 pregnancies. On average, the labs correctly spotted Down syndrome babies 74% of the time.
In at least one case, Chang Wang, the president of Acu-Gen, has phoned a pregnant woman one month after giving her the sex prediction to inform her that her test indicated an "excess of genetic material in her blood" and advised her to see her doctor in order "to rule out problems like Down's syndrome or Trisomy 18". Wang explains this means "with a certain possibility, that her fetus has a kind of genetic problem. Of course later on, we had used our technology to prove that she has a chromosome problem: Trisomy 18. That means that this baby going to have a developmental problem and is going to probably cease to exist right after the birth." Dr. Diana Bianchi of Tufts disputes the possibility of the test being used for such a diagnosis. She says, "The test involves looking at genetic sequences on the X chromosome and the Y chromosome. If he gave a diagnosis of Trisomy 18, that involves a different chromosome, Chromosome 18. That is certainly something that is not advertised in the packaging associated with the test. "It is possible that, upon being told of a problem by Acu-Gen, a woman may seek to have an amniocentesis or other invasive procedure which may be an unnecessary risk if the Acu-Gen diagnosis was in error. In this case, the woman delivered a healthy baby free from both Trisomy 18 and Down syndrome.
The class action lawsuit filed by Gainey & McKenna alleges that Acu-Gen is improperly dispensing medical advice. The law firm claims Wang has contacted "many women" and advised them that their fetuses have chromosomal abnormalities. They claim that Dr. Wang, who is listed as a Ph.D., is providing women "with all sorts of medical advice and diagnoses". They say their clients have suffered great emotional distress and have undergone unnecessary medical testing based upon Dr. Wang's "advice".