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As featured on NBC's Today show -- watch the Baby Gender Mentor Home DNA Gender Testing Kit TODAY show segment now! Offered Exclusively Online From PregnancyStore.com!
ePregnancy Magazine March 2006
Baby Gender Mentor Named as one of the "Build a Better Mousetrap" Top Ten Products of 2005 by Data Monitor
BabyZone.com Boy or Girl? Find Out With Do-It-Yourself DNA Tests
By Debra Goldschmidt
Updated: 8:57 a.m. ET Oct. 18, 2005
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.
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.
© 2005 Newsweek, Inc.
© 2005 MSNBC.com
To date, Acu-Gen has issued 200% refund checks to a few customers -- NOT for incorrectly identifying the baby's gender at birth, though. Two are for cases involving vanishing twins, one case due to insufficient blood sample, two cases caused by incomplete reactions and three reversal cases of no obvious reasons. All of these eight cases are currently into their second trimester of pregnancy.
Sex Matters: Baby's gender: no longer a secret?
By Katy Kelly
The phrase "It's a boy!" (or "It's a girl!") used to be a delivery room highlight and the obstetrician's one big line. More recently the gender news has often come way ahead of the baby—at around 16 weeks of gestation with amniocentesis or sonogram. Now parents-in-waiting can find out the gender just five weeks after conception and without even leaving home. All this takes is a quick finger jab, a dot of blood, and an overnight FedEx delivery. Two days later the parents can get the results by E-mail.
"It's quite simple," says Susan Scola, a graduate student at the University of Wisconsin–Madison. Scola checked and rechecked her E-mail until she learned, after one day, that she was carrying a girl.
Why find out so soon? "I like to prepare as much as I can," says Scola, adding that she wanted to use the extra weeks "just getting acquainted with gender issues and social issues." Other parents have other reasons. "We've heard everything," says Sherry Bonelli, CEO of PregnancyStore.com, currently the only retailer selling the Baby Gender Mentor Home DNA Testing Kit. "One couple said, 'We have two girls who want nothing to do with a brother, so if it's a boy we need to know so we can get them prepared.'"
The kit is billed as 99.9 percent accurate and comes with a double-your-money-back guarantee. But early knowledge isn't cheap. The kit runs $25 and includes two pregnancy tests and one Acu-Gen blood specimen kit. The lab fee is an additional $250, paid directly to the lab. Says Scola, who is glad she made the investment: "It's kind of a high price point, but if the anticipation is too great, people will pay it."
Imagine waiting nine months.
Test reveals gender early in pregnancy
Ethicists fear use in sex selection
First came the home pregnancy test. Now here comes the home gender test.
A new blood test being marketed to American women offers them the chance to find out whether they are having a boy or a girl almost as soon as they realize they are pregnant, as early as five weeks along.
Just two or three days after mailing the test overnight to a Lowell lab for processing, a pregnant woman can know what color to paint the nursery -- or even decide whether to get an abortion if she wants a child of the opposite sex, a prospect that worries ethicists.
The $275 test works by detecting and analyzing fetal DNA floating in the mother's blood, a method that researchers say holds promise for serious clinical uses, from cancer testing to prenatal diagnosis of Down syndrome.
The test, called the Baby Gender Mentor, is meant for ''the type of woman who can't wait to open Christmas presents," said Sherry Bonelli, president of Mommy's Thinkin', the company that is marketing the test at an online pregnancy store.
But ethicists asked about this early, commercial application of fetal DNA testing say it raises concerns about sex selection, particularly in societies and immigrant groups where boy babies are preferred.
''You can tiptoe around it, but the fact is that if you're sending information about sex, then you're in the sex-selection testing business," said bioethicist Arthur Caplan of the University of Pennsylvania. He would not ban the test, he said, but ''I would condemn it."
Sex selection, mainly using ultrasound tests and abortion, is considered a growing and potentially destabilizing problem in parts of Asia. In its most extreme form, parents kill girl babies. In China, it has led to an imbalance of about 120 men for every 100 women; and in India, one recent report from an affluent area of New Delhi found that for every 1,000 boys born in 2004, only 762 girls were born.
America is different, of course. ''There's always that slim possibility" that a woman could use the new gender test for sex selection, Bonelli said, ''but I think the numbers are so small it makes that concern insignificant."
Still, US bioethicists and pregnancy doctors tend to discourage sex selection, with the major exception of its use by couples whose offspring may inherit sex-linked diseases. Sex selection ''may ultimately support sexist practices," according to the official ethical position of the American College of Obstetricians and Gynecologists.
Currently, most expectant mothers have the chance to get a good -- though not always guaranteed -- idea of a fetus's gender when they have a routine ultrasound to check its health when they are about 16 weeks pregnant. Women who have an invasive procedure such as amniocentesis to check the fetus's chromosomal makeup for defects can also find out the gender for sure, usually at about three or four months. Those procedures carry a slight risk of miscarriage, however.
A blood test for fetal DNA, in contrast, offers a noninvasive way to peek at the fetus's genes. One researcher has even suggested that in the future, it may be used to perform a complete genome scan on an embryo.
Baby Gender Mentor hit the market June 17 with an exclusive announcement on NBC's ''Today."
Scientific work on fetal DNA analysis has been racing ahead since the late 1990s, when researchers first discovered, to their amazement, that in a pregnant woman's blood, some ''cell-free" DNA -- DNA that is floating around in clumps rather than contained in the nucleus of a cell -- comes from the fetus. The fetal DNA is believed to get into the mother's blood through the barrier of the placenta.
The test includes a finger-prick kit for collecting a blood specimen, which is then sent to the lab for analysis. The lab amplifies the DNA and then looks for the presence of a Y chromosome, which only males have. Presence of the chromosome generally means the fetus must be male; its absence means a female.
Technically, that is ''a piece of cake," said Dr. Charles R. Cantor,
professor of biomedical engineering at Boston University, who cofounded
''The sex test is very controversial because it's not clear that you want to broadly facilitate the ability of people to sex-select embryos at a very early stage," he said. ''It's potentially abusable."
Cantor said he, like many other researchers, is much more interested in developing tests for diseases, such as cystic fibrosis and Down syndrome. Similar technology could be highly useful in cancer tests, he noted, because tumors -- like fetuses -- release free DNA into the bloodstream. So a cancer patient who today must undergo a painful bone-marrow test may, someday soon, be able to get by with a simple blood test.
The broader potential is not lost on Acu-Gen Biolab, the Lowell laboratory that is handling the Baby Gender Mentor tests. Its scientific director, Dr. C. N. Wang, said the gender tests are meant in part to demonstrate the power of an innovative DNA technique.
That technique allows the lab to reach definitive results from a drop of dried blood instead of the fresh blood usually required by medical diagnostic tests, Wang said. Scientific journals have reported near-perfect accuracy on similar tests, and the lab promises 99.9 percent accuracy or double money back. But Wang said the company is not yet ready to publish its data on the technique and its accuracy. Publication would ensure that other scientists reviewed the data.
''The point here is that we're using a very simple service to demonstrate an amazing aspect of DNA that has never been thought about," he said. Acu-Gen, too, he said, is pursuing possible uses of the technology in cancer and prenatal diagnosis.
Since the announcement on ''Today," thousands of the tests have been ordered, Wang said. The US Food and Drug Administration told the company that it did not need approval because the test would not be used for a medical diagnosis, he added.
It remains to be seen how big the market for a gender test will be among the roughly 4 million American women who give birth each year. (Bonelli said that her company will ship only to the United States.) The test's ads cite estimates that more than half of expectant parents want to know the baby's sex in advance.
A Toronto lab, Paragon Genetics, has been offering a similar test for about two years to expectant mothers, though it starts at 10 weeks instead of five, costs $390, requires a vial of fresh blood, and gives results in 10 business days instead of 48 hours. The lab's director, Yuri Melekhovets, declined to disclose the level of demand, saying he feared attracting competitors.
The Baby Gender Mentor setup concerns him a bit, he said, because, judging by his experience and reports published in journal articles, it appears that fresh blood works best.
He is aware of the potential ethical concern of sex selection, Melekhovets said, but contends that the problem is not the product, but what is done with it.
''We supply the information," he said, ''and what you do with the information is up to you."
Carey Goldberg can be reached at firstname.lastname@example.org.
2005 The New York Times
American Fitness Magazine January/February 2006
NBC Today Show NBC's TODAY Show featured Sherry Bonelli of PregnancyStore.com and Holly Osburn discuss the gender test that can tell the sex of a baby much earlier in a pregnancy; Dr. Ronald Wapner of New York Presbyterian Hospital comments on the test June 17, 2005
WREX-TV Rockford NBC Featured Baby Gender Mentor Story June 17, 2005
KFDA-TV Amarillo CBS Featured Baby Gender Mentor Story June 17, 2005
DallasNews.com Featured Baby Gender Mentor
Forbes.com Featured Baby Gender Mentor
KRON-4 San Francisco Featured Baby Gender Mentor
KVVU-TV Las Vegas FOX Featured Baby Gender Mentor
National Hispanic Corporate Counsel Featured Baby Gender Mentor
Yahoo! News Featured Baby Gender Mentor
Pittsburgh Live Featured story on Baby Gender Mentor June 17, 2005
KSL-TV NBC Salt Lake City Featured story on Baby Gender Mentor June 17, 2005
ClickonDetroit.com Featured story on Baby Gender Mentor June 17, 2005
WHDH-TV ABC Boston Featured story on Baby Gender Mentor June 17, 2005
The Boston Channel Liz Brunner reports on the Baby Gender Mentor
Baby, One More Tip -- MTV.com
KGO Newstalk AM 810 (San Francisco, CA) June 28, 2005
WSB TV Atlanta (view TV segment)
Home-test kit determines baby’s gender after five weeks
A new kit available for home-testing can determine the gender of a baby
as early as five weeks of pregnany.
Test claims it can tell baby's gender, the Clarion Ledger
The new Baby Gender Mentor Home DNA Gender Test claims to be able to tell parents a baby's gender as early as five weeks after conception. With the kit, a woman tests to confirm her pregnancy, then registers the kit online and pays a testing lab service fee of $250. Next, she'll take a finger-pricked blood sample and mail it to the lab in a pre-paid FedEx envelope. Within two business days upon receiving her blood specimen, the mother will receive the gender test results online.
Tom O'Neal brings you the latest medical breakthroughs in healthcare that you and your family need to know. He can help alert you to the dangers as well as the improvements that could affect your family. Health Watch airs at various times during FOX 2 News.
Reporter: Tom O'Neal
Expectant couples usually have to wait until the fourth or fifth month to find out if they are having a boy or a girl, but no more. In the Fox Files Health Watch, Tom O'neal shows us a new test that can determine the gender of your baby five weeks after conception. Exciting technology that comes with a word of caution.
"it's been a very exciting process for us." "yeah, it's a big deal." A big deal for Bryan and Jennie Newberry of Nixa, Missouri because Jennie is pregnant with their first child. Jennie has a 7-year-old boy, Caleb, from a previous marriage. And the couple wondered what sex their child would be; not that unusual. Sherry Bonelli, president, Mommy's Thinkin, "50-70 percent of those women want to know if they're having a boy or a girl. Currently, the earliest they can find out generally is at an ultrasound, which is usually at around 18-22 weeks."
But Jennie is only 14 weeks along and she and Bryan have known for 8 weeks what they're having... "a boy, we're having a boy." Thanks to this new test: Baby Gender Mentor, which she saw on TV. "there was a lady explaining on there that you just need a little blood and you sent it off and that you would be able to find out what sex your baby is starting at five weeks." Bryan Newberry, "I think if you can find out sooner rather than later and get a head start, especially giving you a little more extra time, it's a good thing." The Newberry's have used that extra time to stockpile clothes for a new baby boy and to get a room ready. "my mom's going to do a 3d mural on it and we've got the bedding on order and it has the vintage fire trucks, so we're going to kind of do an old city scene." They're confident in the results which come with a 200% money-back guarantee. Sherry Bonelli markets the test online. "even with ultrasound, the accuracy rate is usually only 80-90%. So the baby gender mentor is really the least invasive way, it's non-invasive, perfectly safe for mom and baby and it's 99.9% accurate."
But not everybody is sold on the idea. "it makes you worry about the future of society." Dr. Stephen Lefrak, a medical ethicist at Washington University, worries the test could lead to gender selection and other problems. "it's very complex. But it leads into a whole realm of eugenics, of enhancements, of if I can select for gender; why can't I select for eye color? Why can't I select for other sorts of things which will be able to be tested for?" Bonelli admits some couples could choose to use the test for gender selection. "but in the US, that kind of gender selection isn't condoned, encouraged, and we really don't believe that that's going to be used very often in this case."
The Newberrys insist their decision was based on a busy schedule, he's a fire chief and she's a kindergarten teacher. "and once school starts, I’m not going to have time to choose a nursery and I’m not going to have time to do shopping and so I really wanted to take time to get that started, get all the clothes that I already had folded and organized." It cost Jennie $25 dollars to order the test. It was simple. She pricked her finger and dabbed blood on a card and sent it off to a lab in Lowell, Massachusetts. For $275, the lab analyzes the fetal DNA in the mother's blood. The results are promised within 48 hours; Jennie received hers in 24. "and of course I was on the computer for that 24 hours, every hour, checking to see if it was there." And the news has allowed them to choose their baby's name already.. Which they shared with us: "Aiden."
You can only get the baby gender mentor test online. For more information or to order the test, log onto www.pregnancystore.com.
Gender tests at 5 weeks can be done, but should they?
Lab says it can determine a baby's sex early, raising fears among ethicists
By MARK BARNA, Californian staff writer
But what if you could know at five weeks?
"I'd want to know," said Nichole Jennings, 25, visiting Baby Sightings in southwest Bakersfield for an ultrasound during her seventh month of pregnancy. "I'm impatient, especially since this is our first child," she said, adding that knowing gender would've enabled her to get a jump on buying either boys or girls clothes.
Jennings and other expectant mothers might have their wish.
A lab in Massachusetts claims to have developed technology that can determine baby gender at five weeks -- or double your money back. The lab touts an accuracy rate of 99.9 percent.
But learning gender at such an early stage worries ethicists, who wonder if some women might terminate the pregnancy if the embryo is not the gender they had hoped for. Abortions are rarely performed after the first trimester but are a relatively common procedure at five weeks.
The test made its public debut on the "Today" show in June. The blood-test kit can be purchased only online for $25. Expectant mothers prick their finger for a drop of blood, then overnight the sample and $250 to a lab in Massachusetts. Test results are e-mailed back within 48 hours.
Bioethicists are concerned that identifying gender at such an early stage in pregnancy will make it easier psychologically for women and couples to select for sex by having an abortion.
Sex selection has long been a big issue in China, India and the Middle East, where a male birth can be preferred to a female birth for cultural reasons.
While the normal ratio is 105 boys to every 100 girls, in China the ratio is 120 males to 100 females, the Boston Globe has reported. In India in a part of New Delhi, a 2004 report found that for every 1,000 boys born, there were 762 newborn females.
Jacquelyn Ann K. Kegley, a bioethicist at Cal State Bakersfield, indicated that gender selection not only skews the balance between male and female, "it also literally says that females are not worth as much as males.
"Gender selection is a real worry."
Aware of the preference for male babies in some parts of the world, Mommy's Thinkin', the product's online marketer, is making the test available only in the United States and Canada.
Sherry Bonelli, president of Mommy's Thinkin', acknowledges that some women, even in America and Canada, might use the test for sex selection. "But if there are women out there who will have an abortion based on gender," she said, "that number is really small."
Another problem with gender testing so early in a pregnancy, ethicists say, involves the emotional well-being of the mother.
The first trimester of pregnancy is an antsy time for many women, some of whom are superstitious about sharing their news because the risk of miscarriage is higher during the first several weeks.
Ethicists say that if a mother knows gender at five weeks, she may become more attached to the baby, thereby suffering greater emotional pain if she miscarries during the second or third month.
"The fetus has now become an individual, a boy or a girl, part of the family history and memory," Kegley said. "This could cause added trauma to the woman if she miscarries."
So far, one buyer has returned the test kit unused after suffering a miscarriage, Bonelli said.
Fetal DNA testing has progressed dramatically since the late 1990s, when researchers first discovered that the DNA of an embryo is present in the mother's blood. When testing the sample, the lab checks the DNA for a Y chromosome, which only males have. If the Y chromosome is detected, it's likely the embryo is male. Otherwise it's probably a female.
The technology may someday be used for prenatal testing for Down syndrome and other chromosomal conditions, researchers say. As it is now, the test has not been approved by the Food and Drug Administration because it's not being used for diagnostic purposes.
Lack of FDA approval worries Cal State professor Kegley. "Genetic testing is a very new field," she said, "and if it's not FDA approved, I'd be suspect."
C.N. Wang, scientific director of Acu-Gen Biolab, which has partnered exclusively with Mommy's Thinkin' to market the technology, has said the lab's embryo DNA testing procedure is nearly perfect in accuracy. Still, the procedure has not been published in a scientific journal.
The publishing of a new technology potentially opens it to criticism within the scientific community.
Mommy's Thinkin' has sold more than 1,000 test kits since its "Today" debut.Some customers, Bonelli said, e-mail the company to say they purchased the test because they wanted an early jump on buying, for instance, the blue or pink pajamas and bedspread.
One purchaser e-mailed to say she has two daughters who want only a baby sister. "So her thought was that if she is having a boy," Bonelli said, "she needs time to get them used to having a baby boy."
Most expectant mothers learn the baby's gender at 16 weeks from a diagnostic ultrasound. Another method is through an amniocentesis at three or four months (usually for women 35 and older), an invasive procedure that checks for chromosomal abnormalities and conclusively determines gender.
The new DNA blood test not only lets parents know the sex earlier, it is also noninvasive -- all that's required of the woman is a finger prick.
Linda Lafave, who accompanied daughter Jennings and other family members to Baby Sightings for an ultrasound, said she saw the product's debut on "Today" and wished it had been available earlier so her daughter, who is expecting a girl, could have used it.
"I would have bought one," Lafave said. "That way I could start buying clothes for the baby earlier. I've already bought $500 worth of girls clothes."
Lafave, 47, doesn't think women getting the DNA blood test will be running out for abortions if the embryo is not the gender they preferred.
"As moms will tell you, it's not about gender," she said, "it's about having a baby."
As for miscarriages, the soon-to-be grandmother pointed out that it can occur any time up to 20 weeks (after which it is known as a stillbirth).
"Knowing the baby's gender at five weeks isn't going to make a miscarriage hurt any less," said Lafave, who said she'd had a miscarriage at 18 weeks.
"When you can select for gender before pregnancy, that's when there
will be an ethics issue," Lafave said. "Otherwise I don't see one."
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