Everything about Baby Gender Mentor totally explained
Baby Gender Mentor is the
trade name of a controversial
blood test designed to determine whether a
pregnant woman is carrying a
male or
female child. The test is made by Acu-Gen Biolab, Inc., a
biotech company in
Lowell, Massachusetts,
United States, and is marketed to detect the
sex of a
fetus as early as five weeks after
conception. The test made a prominent media debut on
17 June 2005 on
The Today Show and about 4,500 people had purchased the test by March 2006.
The test and its competitors represent an alternative to medical procedures which determine the sex of the fetus, such as
amniocentesis and
ultrasound. One possible advantage of using blood tests for prenatal sex testing is the minimally invasive nature of this method. In contrast, there are small, demonstrated risks associated with amniocentesis, and some authorities believe that there could be theoretical risks associated with ultrasound. Women may have many motivations for using a test to learn the sex of their fetuses early in pregnancy, including mental preparation and planning gender-specific purchases, or more controversially, prediction of sex-chromosome-linked genetic diseases and disorders related to sexual development, However, they've not made public any clinical evidence to support these claims.
Customers and scientists have questioned the accuracy of the test, Results are posted to the company's website (with password-restricted access) within two
business days. In particular, Acu-Gen isn't obliged to disclose results of any tests or
patient trials of the test that they may have conducted. One unnamed Acu-Gen spokesperson was quoted as saying the 99.9% accuracy figure is based on 20,000
births, but that the company "won't publish results until it has
patented its technology."
According to the company, the Baby Gender Mentor laboratory analysis will report one of four possible results to the pregnant woman: Male, Female, Twins, or Inconclusive. A result of "Male" indicates that only male fetal
DNA was present and so the pregnant woman must be carrying one or more boys. Similarly, a result of "Female" indicates that only female fetal DNA was detected and the woman is expecting one or more girls. If the result is "Twins" then both male and female fetal DNA were detected and the pregnancy includes one or more boys and one or more girls. If the test is "Inconclusive" then Acu-Gen refers the customer to their
warranty policy and procedure.
Initial media attention
The test was featured on an episode of
The Today Show in June 2005. Bonelli said that the test had only been available for two weeks and that numerous people had inquired about it in that short time. She also said that Acu-Gen had followed 2,000 pregnancies through to completion and that the lab results given by the Baby Gender Mentor had never been wrong in those trials. who discussed possible pros and cons of the test.
Accuracy of the test disputed
At least 40 women have come forward to say their Baby Gender Mentor tests predicted the wrong sex.
Two papers have reported that a vanishing twin may occur in 12% of all pregnancies,
with other studies reporting as little as 3%.
However, even if vanishing twins are assumed to be a common occurrence, they don't explain all of the apparent incorrect results. According to Acu-Gen's website, they can 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.
In contrast to the criticisms, a website offering the test for sale has testimonials from women who have received successful predictions from the test. The on-line retailer PregnancyStore.com has advertised themselves as the exclusive distributor of the test. Sherry Bonelli, CEO of PregnancyStore.com, says that scientists who are skeptical about the test are jealous of Acu-Gen and that the skeptics have not produced any evidence to show that the test is inaccurate. Dr.
Charles Lockwood, chairman of obstetrics and gynecology at
Yale School of Medicine, said that it's 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." 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're 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. Acu-Gen has characterized the legal challenge as a "totally bogus lawsuit". The
Better Business Bureau has stated that the company "has an unsatisfactory record with the Bureau". As of
January 19 2007 the BBB reports they've processed 23 complaints in the last 12 months and 30 in the last 36 months. Twelve of these were listed as "unresolved" or "no response".
Possible uses for test
Parents might like to know this information early in order to get a head start on shopping for baby clothes or decorating the
nursery; others 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. The actual motivations of most women who have used Baby Gender Mentor are unknown.
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 an
abortion as a means of
sex selection. 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's 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." In China, sex selection has led to men outnumbering women by 55 to 45. In a certain portion of
New Delhi, only 762 girls were born per 1,000 boys.
Not all experts agree that sex selection is unethical or that it should be prohibited. Kimberly Mutcherson, an assistant professor at
Rutgers School of Law - Camden, argued that people should be able to use the information any way they want: "People make sex selection decisions for many reasons — to balance their family, or to check for sex specific disease. If you believe women have the right to choose, those are perfectly legitimate reasons." Mutcherson teaches
tort law at Camden and her research interests include health law, family law, and bioethics.
The website for the PregnancyStore.com says that that'll ship the tests only within the United States, though the test has been purchased by customers in
Canada Sheila McLean, professor of
medical ethics at
Glasgow University, is critical of the kits. She said, "This firm could be making claims they can't substantiate, luring people into thinking they've information on which they can act. For some mums and dads, that might only go as far as painting the nursery pink but others may terminate a pregnancy because they believe they're not getting what they want. That's enough of an ethical minefield but what if they were to abort a child they did want?"}}
Tests similar to the Baby Gender Mentor test can be used for medical diagnoses. For instance, scientists have shown that it's 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. Wang explains this means "with a certain possibility, that her fetus has a kind of genetic problem. Of course later on, we'd used our technology to prove that she's a chromosome problem:
Trisomy 18. That means that this baby [is] going to have a developmental problem and is going to probably cease to exist right after the birth." In this case, the woman delivered a healthy baby free from both Trisomy 18 and Down syndrome. The attorney Barry Gainey, of Gainey & McKenna, says that Chang Wang, Acu-Gen's President, is "making people send in the original
birth certificate. He's making them get blood tests from the newborn baby. And there's other requirements that he's now adding to the refund in order to avoid paying back these people and giving them the 200-percent refund." None of those requirements were on the boxes shipped to early customers, but the requirements have since appeared on Acu-Gen's website. Gainey has filed a class action lawsuit on behalf of 40 people who claim they received inaccurate results but were unable to obtain refunds from Acu-Gen. Yet in October 2005 he'd stated his company had issued four refund checks, including one for a case involving a vanishing twin.}}
In March 2006, Wang wrote in an e-mail to NPR, he's "decided to defer all his energies regarding the BGM product and service for one more year, when results of actual births compared to the results provided by Baby Gender Mentor should answer any concern about the accuracy of the test."}}
PregnancyStore.com also updated their website to state that the warranty was only 100% of the purchase price. As of January 2007, PregnancyStore.com no longer contains any mention of the kit on their website, although the Acu-Gen website does contain a form for on-line purchasing of the kit.
About Acu-Gen
Acu-Gen is a biotech company in Lowell, Massachusetts and is led by Cheng Wang, the company's President. A National Public Radio reporter visited the address given as the headquarters of Acu-Gen in September 2005. They found that the building at that address contains a
Hindu temple and a company called
BioTronics, but no sign for Acu-Gen. According to NPR, their inquiries at BioTronics revealed the two companies have common ownership, but no one was available to comment for the NPR story.
A news crew from television station
WFTS, an
American Broadcasting Company (ABC) affiliate, visited the Acu-Gen offices in February 2006. They found "about six employees inside Wang's lab, some putting together sex test kits, others doing some type of lab work. There was a room full of machines Chang said he created, and shelves stacked with blood samples supposedly sent in by women from across the United States."
It isn't known whether the two
journalists visited the same address, nor is it known whether Acu-Gen and BioTronics currently share office or laboratory space. As of January 2007, Acu-Gen lists their address as "50 Stedman Street, Lowell, MA". On
December 2 2006 BioTronics'
trademark on "AmpliSensor" (U.S. trademark registration number 1958576) was declared dead and cancelled. At that time, BioTronics' address was listed as "44 Stedman Street, Unit 5, Lowell, MA".
Competition
Besides Acu-gen, at least three other companies offer pre-natal sex testing using maternal blood. None of these companies has received as much media attention, nor caused as much controversy, as Acu-Gen.
A
Toronto lab, Paragon Genetics, has offered a similar test since 2003. Paragon Genetics's director, Yuri Melekhovets, said the Baby Gender Mentor setup concerns him somewhat because from his experience and knowledge of the literature, "it appears that fresh blood works best [fortesting]." The test is designed to work as early as six weeks into a pregnancy. DNA Worldwide, part of the American group Consumer Genetics, says its test is 98 per cent accurate. The Pink or Blue test has raised concerns in
Australia, where the test can be obtained for just under $500 Australian dollars. In May 2007 Australia's health minister,
Tony Abbott, has said he'd launch an investigation into the Pink or Blue test.
Further Information
Get more info on 'Baby Gender Mentor'.
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