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.