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Baby Gender Mentor

2007 Schools Wikipedia Selection. Related subjects: Health and medicine

   The Baby Gender Mentor test is a blood test designed to determine if a
   pregnant mother is carrying a boy or a girl. The test is made by
   Acu-Gen Biolab, Inc, a biotech company in Lowell, Massachusetts, in the
   United States and is marketed to detect the gender of a fetus as early
   as five weeks after conception. An estimated 50-70% of expectant
   parents would like to know the gender of their child ahead of
   delivering the baby. Some parents would 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.

   The company says that the accuracy of the test exceeds that of
   conventional methods, such as ultrasonography, amniocentesis, chorionic
   villus sampling and serum-DNA QPCR technique and that their test offers
   "unsurpassed accuracy, unrivaled earliness, and uncompromised
   promptness". The product packaging states the test is 99.9% accurate,
   and some advertising has stated an accuracy of 99.99%. The company
   offers a money-back guarantee that all test results will be available
   within 48 hours after receiving a sample and that the result will be
   accurate. Acu-Gen has so far chosen not to release details of how the
   test works or proof of its accuracy, as they consider this information
   proprietary. 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 has been the centre of several controversies. Some customers
   and scientists are questioning the accuracy of the test. A class-action
   lawsuit has been filed against Acu-Gen and a major supplier of the test
   is under criminal investigation. Concerns have also been raised by
   bioethicists that use of the test could lead to unethical practices
   such as gender selection. There have also been anecdotal reports of
   Acu-Gen making additional claims for use of the test in ways that are
   not described in the product packaging or on the company's website.

How the test works

   Acu-Gen reports that the test can tell expectant parents the sex of an
   embryo as early as five weeks into the pregnancy. The expectant mother
   first purchases a test kit for US$ 25.00. She then pricks her finger to
   draw a small amount of blood, which she places on a card; then she
   places the card in the kit. The kit is sent to Acu-Gen where the test
   is processed for an additional $250 fee.

   The Food and Drug Administration doesn't regulate the test because the
   test is classified as non-medical. Therefore, the regulatory hurdles
   that apply to pharmaceutical products do not apply to the Baby Gender
   Mentor test. In particular, Acu-Gen is not obliged to disclose results
   of any tests or patient trials of the test that they may have
   conducted. One un-named AcuGen spokesperson has been 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 website, the test works by detecting fetal
   cells that have entered the mother's bloodstream through fetomaternal
   microchimerism. They list several scientific papers that are related to
   this general field of study, but the cited publications do not refer
   specifically to the Baby Gender Mentor test. The sample is tested for
   the presence of the Y chromosome, which is present only in males. If
   there is no Y chromosome, the embryo is female.

Acclaim for the test

   The test was featured on an episode of the Today Show in June 2005. In
   that show, Katie Couric interviewed a woman named Holly Osborn who at
   that time was mother to two daughters and expecting a third child. Also
   interviewed was Sherry Bonelli, the CEO of PregnancyStore.com, an
   Illinois-based on-line retailer where Osborn purchased her test.
   Bonelli is also the president of a company called Mommy's Thinkin which
   is reportedly involved in marketing the Baby Gender Mentor test.
   Bonelli said that the test had only been available for two weeks and
   that numerous people had inquired about the test in that short time.
   She claimed that AcuGen 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.

   Osborn said that she wanted to know the gender of her unborn baby
   because her house was filled with "pink and purples and lots of green"
   and she wanted to know if she needed to paint the nursery blue. She had
   agreed to have her test results announced to her on the show, and
   Bonelli informed her that her unborn baby was a girl, according to the
   results of the test.

   In the Today Show segment, Couric also interview Dr. Ronald Wappner,
   head of maternal fetal medicine at New York Presbyterian Hospital, who
   noted two potential concerns about the test. His first concern was
   whether the claimed 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 the a baby of the desired gender. Wappner 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
   unborn baby.

   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

   While the Food and Drug Administration doesn't regulate the test, which
   is classified as non-medical, several women have come forward to say
   their tests were wrong. With Acu-Gen so-far choosing not to publish
   proof of its claims, anecdotal evidence of several women receiving
   conflicting predictions worries Diana Bianchi. Bianchi is an expert on
   fetal DNA at Tufts University whose work is listed on Acu-Gen's Web
   site as scientific evidence that supports the workings of the test. "I
   think at the present time we need to be concerned whether the test is
   accurate or not," Bianchi says. "I think it's caveat emptor. Let the
   buyer beware."

   According to a National Public Radio (NPR) radio report, the company
   has explained previous inaccurate results as being the result of a
   vanishing twin, which is a fetus that stopped growing soon after
   fertilization. Vanishing Twin Syndrome occurs when one of the fetuses
   in a twin pregnancy spontaneously aborts, usually during the first
   trimester. The fetal tissue is absorbed by the other twin, the
   placenta, or the mother, thus giving the appearance that the twin
   "vanished." This usually results in a normal singleton pregnancy. It
   has been estimated that as many as 1 in 8 people begin life as a twin,
   but only 1 in 70 are actually born as twins. Vanishing twins could
   theoretically explain apparent errors in the Baby Gender Mentor test.
   If fraternal twins, one male and female, were present when the test was
   taken, the test should indicate the presence of a male embryo. If that
   embryo later "vanishes", leaving the female baby to develop normally,
   the test could appear to be in error when it was in fact accurate at
   the time. The medical community is not in general agreement about the
   vanishing-twin phenomena. If the twin is reabsorbed with no evidence it
   existed, then there is no evidence to support whether the twin existed
   or not.

   "Until Acu-Gen releases its data, there's no way to know the test's
   reliability, said Sandra Carson, a professor of obstetrics and
   gynecology at Baylor College of Medicine who specializes in sex
   selection. "Until that's out, I think it shouldn't be on the market,"
   she said.

Tool for gender selection?

   The (NPR) investigative report on Acu-Gen also anticipates that some
   parents may use the Baby Gender Mentor test as a basis for determining
   whether to get an abortion as a means of gender selection. That concern
   is shared by Dr. Analia Bortz. She provides counseling to new parents
   and she is concerned some parents will use the early test as a way to
   select the gender of their baby. The concern is that learning the
   gender at such an early time-point may lead some 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 claims that some
   women disappointed by the result of their test would find it easier to
   have an abortion. Their spokesman Daniel McConchie said, "Women who are
   interested in only having one gender will be finding out in a time when
   it's certainly safer for them to have an abortion without the
   complications normally associated with those that would come later in
   pregnancy." Arthur Caplan, director of the Centre for Bioethics at the
   University of Pennsylvania, said that while gender selection is not a
   frequent occurrence in the United States, it is a concern in countries
   like India and China, where having boys is preferred over having girls.
   In China, gender selection has led to there being about 20% more men
   than women. In India, a recent report found that for every 1,000 boys
   born in 2004 in a certain portion of New Delhi, only 762 girls were
   born. The website for the PregnancyStore.com says that they will ship
   the tests only within the United States, though it has been reported
   that the test is also available in Canada.

Testimonials and legal challenges

   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 Pregnancy Store.com has advertised
   themselves as the exclusive distributor of the test. Sherry Bonelli,
   CEO of Pregnancy Store.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.

   Gail O'Conner, a spokesperson for the Illinois State Attorney General,
   says that they are investigating The Pregnancy Store.com for possible
   fraud. 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 honour its
   money-back guarantee.

About Acu-Gen

   Acu-Gen's President is named Chang Wang. The company is based in
   Lowell, Massachusetts. A National Public Radio reporter visited the
   address given as the headquarters of Acu-Gen. 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, also visited the Acu-Gen offices. They found "about six
   employees inside Wang's lab, some putting together gender 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."

Warranty and availability

   Allegedly, Acu-Gen is creating new requirements for people who want to
   take advantage of the money back guarantee. The attorney Barry Gainey
   of Gainey & McKenna says that Wang 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.

   There have been conflicting reports about how often the company has
   refunded money to consumers who received an erroneous result with the
   test. In February 2006, Acu-Gen's President Chang Wang said, "We don't
   mistakes. Period." (sic) Yet in October 2005 he had stated his company
   had issued four refund checks, including one for a case involving a
   vanishing twin. The Pregnancy Store.com claims that none of the refund
   checks were issued as a result of the test being proven wrong by a live
   birth. Their website states:

     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.

   In March 2006, Wang said in an e-mail to NPR, he has "decided to defer
   all his energies regarding the BGM product and service for one more
   year, when results of actual births compared to results the results
   provided by Baby Gender Mentor should answer any concern about the
   accuracy of the test."

   Initial news reports and the Acu-Gen website touted a 200% money-back
   guarantee. In May 2006, the Acu-Gen website was modified to show a
   different warranty than the one that had originally promised to refund
   200% of the purchase price of the test. The new warranty states:

     We guarantee that all test results are 99.9% accurate. If your test
     results are legitimately incorrect, Baby Gender Mentor will refund
     you all costs that include laboratory and purchasing expenses.* A
     valid registration code and a birth certificate are required for the
     refund. You MUST read and follow all kit instructions. Baby Gender
     Mentor is not responsible for any consequences resulting from
     failure to follow kit instructions. To claim the refund, the birth
     certificate should include BOTH the address and name of the
     purchaser. In some instances, Baby Gender Mentor may request the
     finger press of the baby to conclude the refund process...

   The PreganancyStore.com also updated their website to reflect that the
   warranty now refunds only 100% of the purchase price. As of July 2006,
   the Pregnancy Store.com reports that the test is currently out of
   stock.

Beyond gender testing

   Scientists know that it is possible to use fetal DNA from a mother's
   blood to screen the unborn baby for genetic defects such as Down's
   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's Syndrome in 2,744
   pregnancies. On average, the labs correctly spotted Down's Syndrome
   babies 74% of the time.

   In at least one case, Wang has phoned an expectant mother one month
   after giving her the gender 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 [is] going to have a
   developmental problem and is going to probably cease to exist right
   after the birth."

   Dr. Diana Bianchi of Tufts says the Baby Gender Mentor, as described in
   its advertising, wouldn't be able to determine such a claimed
   abnormality. 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."

Competition

   A Toronto lab called Paragon Genetics has been offering a similar test
   since approximately 2003. Their test may be taken beginning at 10 weeks
   into the pregnancy as opposed to the five weeks claimed by AcuGen. The
   Paragon Genetics test costs $390, requires a vial of fresh blood, and
   takes 10 business days to return results instead of 48 hours. The lab'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 [for testing]." He
   also said he is aware of the ethical concerns surrounding sex selection
   but he says, "We supply the information, and what you do with the
   information is up to you." He also argues that parents can already
   conduct gender selection through other technologies, such as
   ultrasound.
   Retrieved from " http://en.wikipedia.org/wiki/Baby_Gender_Mentor"
   This reference article is mainly selected from the English Wikipedia
   with only minor checks and changes (see www.wikipedia.org for details
   of authors and sources) and is available under the GNU Free
   Documentation License. See also our Disclaimer.
