Baby Gender Mentor
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2008-06-23T21:07:15Z
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[[Image:Baby Gender Mentor box.jpg|right|thumb|The Baby Gender Mentor packaging advertises a controversial 99.9% accuracy rate and a 48-hour turn-around time.]]
'''Baby Gender Mentor''' is the [[trade name]] of a controversial [[blood test]] designed to determine whether a [[pregnancy|pregnant]] woman is carrying a [[male]] or [[female]] child. The test is made by Acu-Gen Biolab, Inc., a [[biotechnology|biotech]] company in [[Lowell, Massachusetts]], [[United States]], and is marketed to detect the [[sex]] of a [[fetus]] as early as five weeks after [[Fertilisation|conception]].<ref name="Total">{{cite web | url=http://babygendermentor.com/information.php?information_id=4 | title=A Total Advantage | work=Acu-Gen website | accessdate=2007-01-16}}</ref> The test made a prominent media debut on [[17 June]] [[2005]] on ''[[Today (NBC program)|The Today Show]]''<ref name="Newhouse"/><ref name="Today-flash">{{cite web | url=http://www.webantidote.com/pregnancystore/today_show_flash/ | title=Today Show video segment | work=PregnancyStore.com | format=Flash | accessdate=2006-07-18}}</ref><ref name="Globe">{{cite news | title=Test reveals gender early in pregnancy | publisher=The Boston Globe | date= [[2005-06-27]] | author=Goldberg, Carey | accessdate=2007-01-16 | url=http://www.boston.com/yourlife/health/women/articles/2005/06/27/test_reveals_gender_early_in_pregnancy/}}</ref> and about 4,500 people had purchased the test by March 2006.<ref name="Guardian">{{cite news | url=http://www.taipeitimes.com/News/biz/archives/2006/03/19/2003298170 | title=Parents sue manufacturer of Baby Gender Mentor | publisher=The Taipei Times / The Guardian, Washington | date= [[2006-03-16]] | accessdate=2006-07-17}}</ref>
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.<ref>{{cite journal |author=Church CC, Miller MW |title=Quantification of risk from fetal exposure to diagnostic ultrasound |journal=Prog. Biophys. Mol. Biol. |volume=93 |issue=1–3 |pages=331–53 |year=2007 |pmid=16949653 |doi=10.1016/j.pbiomolbio.2006.07.015}}</ref> 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,<ref name="ABC WNT"/> or sex-selective abortion.<ref name="Fox9"/><ref name="Telegraph"/><ref name="Newsweek"/> The Baby Gender Mentor test is not regulated by the FDA, nor approved for diagnosis of any disease.
According to the company's web site,<ref name="BGM-Science"/> the test involves using [[real-time polymerase chain reaction]] and a proprietary technology to detect markers on the [[Y-chromosome]], which can be isolated from the pregnant woman's blood if the fetus is male. However, the company has kept details of the test proprietary, refusing to publish their data until they receive a patent.<ref name="Science-Mag"/>
The company says that the accuracy of the test exceeds that of conventional methods, such as [[ultrasound|ultrasonography]], [[amniocentesis]], or [[chorionic villus sampling]] techniques, and that their test offers "unsurpassed accuracy, unrivaled earliness, and uncompromised promptness".<ref name="BGM-Info">{{cite web | url=http://babygendermentor.com/information.php?information_id=4 | title=Information on Baby Gender Mentor test | work=Acu-Gen website | accessdate=2005-10-21}}</ref> However, they have not made public any clinical evidence to support these claims.
Customers and scientists have questioned the accuracy of the test,<ref name = "Boyce1">{{cite news| author= Boyce, Nell | date=[[2005-09-29]] | url=http://www.npr.org/templates/story/story.php?storyId=4867895 | title=Critics Question Accuracy of Fetus Sex Test | publisher=National Public Radio | accessdate=2007-01-16}}</ref><ref name = "Boyce2">{{cite news| author= Boyce, Nell | date= [[2005-10-10]] | url=http://www.npr.org/templates/story/story.php?storyId=4952404 | title=Questions Raised Over Accuracy of Gender Test | publisher=National Public Radio|accessdate=2007-01-23}}</ref><ref name="Wash-Post"/> and [[lawsuit|legal action]] is being pursued against Acu-Gen as well as a major supplier of the test.<ref name="Guardian"/><ref name="Boyce2" />
==Test methodology==
<!-- [[Image:BGM test step5 apply blood to the card included with the kit.PNG|right|thumb|Step 5 of the Baby Gender Mentor instructions shows how to apply a few drops of blood to the card included with the kit.]] -->
Acu-Gen reports that the test can tell expectant parents the [[sex]] of an [[embryo]] as early as five weeks into the pregnancy, with accuracy increasing as the pregnancy approaches eight weeks.<ref name="Total"/> They say that after eight weeks, accuracy is consistent throughout the pregnancy and the test may be taken at any time. The test kit costs [[United States dollar|US$]]25.00. To use, the pregnant woman pricks her finger to draw a small amount of blood, which is placed on card; the card is placed in the kit and sent to Acu-Gen, where the test is processed for an additional US$250 fee.<ref name="Newhouse"/><ref name="how">{{cite web | url=http://babygendermentor.com/information.php?information_id=5 | title=Prick finger and collect blood | work=Acu-Gen website| accessdate=2007-01-16}}</ref> Results are posted to the company's website (with password-restricted access) within two [[business day]]s.<ref name="Total"/>
The [[Food and Drug Administration]] (FDA) does not regulate the test because the test is classified as non-medical and not marketed as a tool for medical diagnoses;<ref name="Newhouse"/> therefore, the regulatory hurdles that apply to [[Pharmaceutical company|pharmaceutical]] products do not apply to the Baby Gender Mentor test.<ref name="Revisit">{{cite news | title=Revisiting the Baby Gender Mentor | author=Boyce, Nell and Inskeep, Steve | url=http://www.npr.org/templates/story/story.php?storyId=5235003 | publisher=National Public Radio | date= [[2006-02-27]] | accessdate=2007-01-16}}</ref> In particular, Acu-Gen is not obliged to disclose results of any tests or [[clinical trial|patient trials]] of the test that they may have conducted.<ref name="Science-Mag">{{cite journal | author = Kaiser J| title = An earlier look at baby's genes | journal = Science | year = 2005 | volume = 309 | issue = | pages = 1476–1478|url=http://www.pregnancystore.com/images/Baby%20Gender/Science%20Magazine.pdf| format=PDF| doi = 10.1126/science.309.5740.1476| pmid = 16141041 }}</ref> One unnamed Acu-Gen spokesperson was quoted as saying the 99.9% accuracy figure is based on 20,000 [[birth]]s, but that the company "won't publish results until it has [[patent]]ed its technology."<ref name="Science-Mag" />
Acu-Gen explains the test works by detecting fetal cells that have entered the woman's bloodstream through [[Chimera (genetics)#Microchimerism|fetomaternal microchimerism]]. The company performs two tests: the first is a [[quantitative polymerase chain reaction]] and the other is proprietary. The sample is tested for [[DYZ-1]], a repetitive sequence found on the [[Y chromosome]], which is present only in [[male]]s. If there is no [[Y chromosome]], the embryo is [[female]].<ref name="Newhouse"/> The PCR technique monitors the level of [[fluorescence energy transfer]] between nested [[primers]] that bind next to one another on a strand of DNA, if the gene is present, allowing a single [[PCR]] run to reliably compare the amount of DYZ-1 signal between samples without the need to optimize the number of cycles of amplification. Acu-Gen lists several scientific papers that are related to this field of study, but the cited publications do not refer specifically to the Baby Gender Mentor test.<ref name="BGM-Science">{{cite web | url=http://babygendermentor.com/information.php?information_id=3 | title=Science Behind Facts | work=Acu-Gen website | accessdate=2005-10-21}}</ref>
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.<ref name="Agu-Gen FAQ">{{cite web | url=http://babygendermentor.com/information.php?information_id=6 | title=FAQ—Is The Baby Gender Mentor Test Right For Me? | work=BabyGenderMentor.com | accessdate=2007-01-22}}</ref>
==Initial media attention==
The test was featured on an episode of ''The Today Show'' in June 2005.<ref name="Today-flash" /> In that show, [[Katie Couric]] interviewed a woman named Holly Osburn who was mother to two daughters and expecting a third child. Also interviewed was Sherry Bonelli, the CEO of PregnancyStore.com, an [[Illinois]]-based [[Business-to-consumer electronic commerce|on-line retailer]] where Osburn purchased her test. Bonelli is the president of a company called Mommy's Thinkin which is involved in marketing the Baby Gender Mentor test.<ref>{{cite web | url=http://www.pregnancystore.com/in_the_news.htm#NewsweekArticle |title=PreganancyStore.com in the news! | work=PregnancyStore.com | accessdate=2007-01-16}}</ref></blockquote> 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.<ref name="Today-flash" /> She did not mention how these 2,000 pregnancies are related to the 20,000 pregnancies mentioned separately by Acu-Gen.<ref name="Today-flash" /><ref name="Science-Mag" />
Osburn said that she wanted to know the sex of her baby because her house was filled with "pink and purples and lots of green" and she wanted to know whether to paint the nursery blue. She had agreed to have her test results announced to her on the show, and Bonelli informed her that she was going to have a girl, according to the results of the test.<ref name="Today-flash" />
In ''The Today Show'' segment, Couric also interviewed Dr. Ronald Wapner, head of maternal fetal medicine at [[New York Presbyterian Hospital]],<ref name="NY-Daily">{{cite news | url=http://www.nydailynews.com/front/story/337727p-288375c.html | title=Kit makes it a womb with a view | publisher=New York Daily News | date= [[2005-08-16]] | accessdate=2007-01-16 |author= Haberman, Maggie}}</ref> who discussed possible pros and cons of the test.<ref name="Today-flash" /> 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.<ref name="Today-flash" />
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.<ref name="Think">{{cite news | url=http://www.dailyrecord.co.uk/news/tm_objectid=16574383&method=full&siteid=66633&headline=what-will-they-think-of-next---name_page.html | title=What Will They Think of Next? | date= [[2006-01-12]] | accessdate=2007-01-16 | publisher=Daily Record (UK) | author=Standfield, Robert}}</ref>
==Accuracy of the test disputed==
At least 40 women have come forward to say their Baby Gender Mentor tests predicted the wrong sex.<ref name="Parents sue"/> According to a [[National Public Radio]] (NPR) report, the company has explained certain inaccurate results as being the result of a [[vanishing twin]], a fetus that stopped growing soon after fertilization.<ref name="Boyce2" /> 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 either the other twin, the [[placenta]], or the mother, thus giving the appearance that the twin "vanished." This usually results in a normal, "single" pregnancy. Vanishing twins would 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 and a female embryo; when the male embryo later "vanishes", leaving the female baby to develop normally, the test would appear to be in error, despite being accurate at the time.
The medical community is not in agreement about how frequently vanishing-twin phenomena occurs.<ref name=Landy_1998>{{cite journal |author=Landy H, Keith L |title=The vanishing twin: a review |journal=Hum Reprod Update |volume=4 |issue=2 |pages=177–83 |year=1998 |pmid=9683354 |doi=10.1093/humupd/4.2.177}}</ref>
Two papers have reported that a vanishing twin may occur in 12% of all pregnancies,<ref name="VTS">{{cite web | url=http://multiples.about.com/cs/medicalissues/a/vanishingtwin.htm | author= Pamela Prindle Fierro | title=Vanishing Twin Syndrome | work=About.com | accessdate=2005-10-21}}</ref><ref name=La_Sala_2006>{{cite journal |author=La Sala G, Villani M, Nicoli A, Gallinelli A, Nucera G, Blickstein I |title=Effect of the mode of assisted reproductive technology conception on obstetric outcomes for survivors of the vanishing twin syndrome |journal=Fertil Steril |volume=86 |issue=1 |pages=247–249 |year=2006 |pmid=16716323 |doi=10.1016/j.fertnstert.2005.11.073}}</ref>
with other studies reporting as little as 3%.<ref>{{cite journal |last=Sulak |first=LE |authorlink= |coauthors=Dodson, MG |year=1986 |month=December |title=The vanishing twin: pathologic confirmation of an ultrasonographic phenomenon |journal=Obstet Gynecol. |volume=68 |issue=6 |pages=811–815 |id= |url= }}PMID 3537876</ref><ref>{{cite web | url=http://www.vanishingtwin.com/art01.html |title=Technical Article List | publisher=VanishingTwin.com | accessdate=2007-01-17}}</ref>
However, even if vanishing twins are assumed to be a common occurrence, they do not 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.<ref name="Agu-Gen FAQ"/>
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 web site 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."<ref name = "Boyce1" /> Another criticism has come from Sandra Carson, professor of obstetrics and gynecology at [[Baylor College of Medicine]] 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."<ref name="Wash-Post">{{cite news | author=Ault, Alicia | date= [[2005-07-19]] | url=http://www.washingtonpost.com/wp-dyn/content/article/2005/07/18/AR2005071801128.html | title=The Gender Flap |publisher=Washington Post | accessdate=2005-10-21}}</ref>
In contrast to the criticisms, a website offering the test for sale has testimonials from women who have received successful predictions from the test.<ref name="preg-store">{{cite web | title=Baby Gender Mentor Testimonials | url=http://web.archive.org/web/20060518011921/http://www.pregnancystore.com/baby_gender_mentor.htm | work=PregnancyStore.com | accessdate=2007-01-22}}</ref> The on-line retailer PregnancyStore.com has advertised themselves as the exclusive distributor of the test.<ref name="can't wait">{{cite web | url=http://www.pregnancystore.com/images/Baby%20Gender/ePregnancy_March_06.pdf | title=Can't Wait to Find Out | work=PregnancyStore.com | format=PDF|accessdate=2007-01-16}} </ref> 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.{{Verify source|date=July 2007}}<!-- This is not a reliable source. --><ref name="Blogspot">{{cite web | url=http://doctorfreeride.blogspot.com/2005/09/science-meet-capitalism.html | title=Science, meet Capitalism | work=Blogspot | author=Dr. Free-Ride | accessdate=2005-10-21}}</ref> 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."<ref name="Parents sue"/>
There are multiple legal challenges and investigations under way. Gail O'Conner, a spokesperson for the [[Illinois]] [[State Attorney General]], says that they are investigating PregnancyStore.com for possible [[fraud]].<ref name="Boyce2" /> [[Florida]] [[United States House of Representatives|Congressman]] [[Jim Davis (politician)|Jim Davis]] has urged the FDA to investigate Acu-Gen, and the Florida Attorney General has opened an investigation against Acu-Gen.{{Verify source|date=July 2007}}<!--Personal blog, not a reliable source--><ref>{{cite web | url=http://www.in-gender.com/cs/blogs/Gender_Selection_News/archive/2006/05/31/11567.aspx | title=Congressman urges FDA to investigate Acu-Gen's Baby Gender Mentor, and to regulate similar baby gender tests | publisher=In-gender.com | date=[[May 31]] [[2006]] | accessdate=2007-01-19}}</ref><ref name=ABC Tampa">{{cite news | url=http://www.wfts.com/video/news/2006/05/0528health.shtml | title=ABC Tampa's Linda Hurtado reports Florida congressman urges FDA to investigate Baby Gender Mentor and similar products; Florida attorney general investigates Acu-Gen | publisher=[[WFTS]] | accessdate=2007-01-19 | format=WMV}}</ref> A law firm named Gainey & McKenna has filed a [[class action]] lawsuit<ref name="BGI">{{cite web | url=http://www.babygenderinvestigation.com/ | title=Welcome to BabyGenderInvestigation.com | work=BabyGenderInvestigation.com | accessdate=2007-01-16}}</ref> 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.<ref name="WLOCP">{{cite web | title=Baby Gender Mentor / Acu-Gen | work=Wiliams Love O'Leary Craine and Powers P.C. (WLOPC&P) | url=http://www.wdolaw.com/cases/baby-gender-mentor.htm | accessdate=2007-01-16}}</ref> 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.<ref name="Guardian" /> The law firm cites seven areas of contention, including the veracity of the accuracy claims and the violation of [[HIPAA]] and other laws.<ref name="Allegations">{{cite web | url=http://www.babygenderinvestigation.com/ALLEGATIONS.html | title=Summary of the claims currently being investigated | work=BabyGenderInvestigation.com | accessdate=2007-01-19}}</ref> Acu-Gen has characterized the legal challenge as a "totally bogus lawsuit".<ref name="ABC WNT">{{cite news | url=http://abcnews.go.com/Video/playerIndex?id=1668454 | title=World News Tonight | publisher=ABC | accessdate=2007-01-19}}</ref> The [[Better Business Bureau]] has stated that the company "has an unsatisfactory record with the Bureau".<ref>{{cite web | url=http://www.bosbbb.org/reports/reliability_report.asp?FirmId=25746 | title=Better Business Bureau Serving Eastern MA, ME & VT | work=bosbbb.org | accessdate=2007-05-13 }}</ref> As of [[January 19]] [[2007]] the BBB reports they have 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".<ref name="BBB">{{cite news | url=http://www.bosbbb.org/reports/reliability_report.asp?FirmId=0000025746 | title=Reliability Report | publisher=Better Business Bureau|date=[[January 19]] [[2007]] | accessdate=2007-01-19}}</ref>
==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 (room)|nursery]];<ref name="Newhouse">{{cite news | title=Parents May Welcome Baby Gender Test, But Bioethicists Worry | author=O'Crowley, Peggy | url=http://web.archive.org/web/20060427041104/http://www.newhousenews.com/archive/ocrowley071105.html | date=2005 | publisher=Newhouse News Service|accessdate=2007-01-16}}</ref> others have cited an interest in preparing themselves or the baby's siblings for [[Gender role|gender-specific]] issues.<ref name="USNews">{{cite news | url=http://www.usnews.com/usnews/health/articles/050624/24sex.htm |title=Sex Matters: Baby's gender: no longer a secret? | work=US News and World Report | date=[[2005-06-24]] | accessdate=2007-01-16}}</ref> 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]].<ref name="Boyce2" /> [[KMSP-TV]] interviewed genetic counselor Dr. Analia Bortz who made the same prediction.<ref name="Fox9">{{cite news | url=http://www.kmsp.com/news/health/story.asp?1649175 | title=Baby Gender Mentor | work=Fox9 News | date=2006|accessdate=2006-07-17}}</ref> 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.<ref name="Telegraph">{{cite news | url=http://www.telegraph.co.uk/news/main.jhtml?xml=/news/2005/07/10/wfoetus10.xml&sSheet=/news/2005/07/10/ixworld.html | title=Revolutionary foetus sex test raises eugenics fears | author=Langton, James | publisher=Daily Telegraph | date= [[2005-10-07]] | accessdate=2007-01-16}}</ref>
Some [[bioethics|bioethicists]] believe that sex selection is an [[ethics|ethical]] problem and could be disruptive to [[society]].<ref>{{cite news | url=http://www.npr.org/templates/story/story.php?storyId=4724756 | title=Doctors Question Ethics of Baby Gender Test | author=Neighmond, Patricia | work=NPR.org | publisher=National Public Radio | date=[[June 30]][[2005]] | accessdate=2007-12-31}}</ref> 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."<ref name="Parents sue"/> According to [[Arthur Caplan]], director of the [[University of Pennsylvania School of Medicine|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 like [[India]] and [[China]], where having boys is preferred over having girls.<ref name="Newsweek">{{cite news| title=Gender Bender—A new test claims it can determine fetal gender as early as five weeks into pregnancy. Doctors are skeptical. | publisher=Newsweek | author=Goldschmidt, Debra | url=http://www.msnbc.msn.com/id/9732860/site/newsweek/ | date=[[2005-10-18]] | accessdate=2007-01-16}}</ref> In China, sex selection has led to men outnumbering women by 55 to 45.<ref name="Globe" /><ref name="Asia jitters"/> 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 area.<ref name="Millions missing"> {{cite journal |quotes= |last=George |first=SM. |authorlink= |coauthors= |year=2006 |month=July |title=Millions of missing girls: from fetal sexing to high technology sex selection in India |journal=Prenat Diagn |volume=26 |issue=7 |pages=604–609 |id= |url= |doi=10.1002/pd.1475 }} PMID 16856224</ref> In a certain portion of [[New Delhi]], only 762 girls were born per 1,000 boys.<ref name="Globe" /><ref name="Asia jitters"/> Punjab's [[Indian health ministry|Health Minister]] Ramesh Chander Dogra has said he will take action to ban the test in India.<ref>{{cite news | url=http://archive.gulfnews.com/articles/06/07/03/10051143.html | title=Punjab plans to ban US gender determination kit | publisher=Gulf News|date=[[July 3]] [[2006]] | accessdate=2007-01-19}}</ref>
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."<ref name="Asia jitters">{{cite news | url=http://www.asianpacificpost.com/portal2/402881910674ebab010674f58e2f1d79.do.html | title=New pregnancy test makes Asia jittery | publisher=Asia Pacific Post | date=[[August 11]] [[2005]]|accessdate=2007-01-19}}</ref> Mutcherson teaches [[tort]] law at Camden and her research interests include health law, family law, and bioethics.<ref>{{cite web | url=http://www-camlaw.rutgers.edu/bio/1021 | title=Kimberly Mutcherson | work=Rutgers School of Law—Camden | accessdate=2007-01-22}}</ref>
The website for the PregnancyStore.com says that they will ship the tests only within the United States,<ref name="PregStore">{{cite web | url=http://www.pregnancystore.com/baby_gender_mentor.htm | title=Baby Gender Mentor Home DNA Gender Testing Kit | work=The PregnancyStore.com | accessdate=2006-07-18}}</ref> though the test has been purchased by customers in [[Canada]]<ref name="Think" /> and in [[Scotland]].<ref name="mail-1">{{cite news | url=http://www.sundaymail.co.uk/news/tm_objectid=16282643&method=full&siteid=64736&headline=for-sale-on-the-net--the-sex-of-your-new-baby--name_page.html | title=Exclusive: For Sale: Sex of Your Baby—Anger flares over sex over £150 home test | date=[[October 23]] [[2005]] | author=White, Donna | publisher=Sunday Mail (UK) | accessdate=2007-01-19}}</ref><ref name="mail-2">{{cite news | url=http://www.sundaymail.co.uk/news/tm_objectid=16282644&method=full&siteid=64736&headline=kit-said-i-d-have-a-boy---but-my-tot-s-a-girl--name_page.html| title=Kit said I'd have a boy.. but my tot's a girl | publisher=Sunday Mail (UK) | date=[[October 23]] [[2005]]|accessdate=2007-01-19}}</ref> [[Sheila McLean]], professor of [[medical ethics]] at [[Glasgow University]], is critical of the kits. She said, "This firm could be making claims they cannot substantiate, luring people into thinking they have 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 are not getting what they want. That's enough of an ethical minefield but what if they were to abort a child they did want?"<ref name="mail-1"/>
===Alleged use for medical diagnoses===
The Baby Gender Mentor test is not regulated by the Food and Drug Administration because it is not a medical test or procedure.<ref name="Newhouse"/><ref name="Science-Mag"/> Acu-Gen's website specifically states that the test is not a medical test:
{{cquote|Acu-Gen Biolab, Inc. (“Acu-Gen”) and the www.babygendermentor.com website (“Web Site”) do not offer medical advice or professional services. The products and information provided with the Baby Gender Mentor Test cannot and should not be used for diagnosing or treating a known or suspected health condition or illness. The Baby Gender Mentor Test is not a substitute for medical or professional care. If you have, or you suspect that you or your baby may have, a health condition or illness, you should consult with your doctor. Never disregard medical or professional care or advice or delay seeking it because of something you have learned from Acu-Gen, the Baby Gender Mentor Test or our Web Site. Except for the specific information contained on our Web Site, you cannot and should not rely on any information provided by Acu-Gen, Acu-Gen employees or other visitors to our Web Site. The content of our Web Site is provided on an “as is” basis.<ref name="Things">{{cite web | url=http://babygendermentor.com/information.php?information_id=2 | title=Things you must know | work=BabyGenderMentor.com | accessdate=2007-01-21}}</ref>}}
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.<ref name="Science-Mag" />
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."<ref name="ABC-concern">{{cite news | url=http://www.abcactionnews.com/stories/2006/02/060220gender.shtml | title=Baby gender test leads to great concern for some mothers-to-be | date=[[2006-02-20]] | accessdate=2007-01-16 | publisher=ABC Action News - Tampa}}</ref> 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: [[Edwards syndrome|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."<ref name="ABC-concern"/> 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."<ref name="ABC-concern"/> It is possible that, upon being told of a problem by Acu-Gen, that 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.<ref name="NJSL">{{cite news | title=Prenatal test reveals more than gender | publisher=New Jersey Star-Ledger|date=[[October 31]] [[2005]] }}</ref> In this case, the woman delivered a healthy baby free from both Trisomy 18 and Down syndrome.<ref name="ABC-concern"/>
Another case was documented in an ''[[World News with Charles Gibson]]'' featuring one of the women who are suing Acu-Gen. According to the woman, when Acu-Gen's prediction of a boy did not match with the ultrasound prediction of a girl, Wang told her to expect a baby with [[intersexuality|ambiguous genitalia]]. She later gave birth to a baby girl with normal female genitalia.<ref name="ABC WNT"/>
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".<ref name="Allegations"/>
==Warranty and availability==
Acu-Gen has allegedly created new requirements for people who want to take advantage of the money-back guarantee.<ref name="balks">{{cite web | url=http://www.in-gender.com/cs/blogs/Gender_Selection_News/archive/2005/12/29/4559.aspx | title=Acu-Gen balks at giving refunds for birth certificates showing Baby Gender Mentor was wrong | publisher=InGender.com | date=[[December 30]] [[2005]] | accessdate=2007-01-19}}</ref> 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.<ref name="ABC1">{{cite news | title=Baby gender test spawns talk of class-action lawsuit | url=http://www.wfts.com/stories/2006/02/060221gender.shtml | date=[[2006-02-21]] | accessdate=2007-01-16 | publisher=ABC Action News—Tampa}}</ref><ref name="Parents sue">{{cite news | url=http://abcnews.go.com/Health/story?id=1668125 | title=ABC News: Parents Sue Over Pregnancy Test Said to Tell Baby's Sex | author=Zand M.D., Sarvenaz|date=[[February 26]] [[2006]] | accessdate=2007-01-19}}</ref> 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.<ref name="Parents sue"/>
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, Wang said, "We don't mistakes [''[[sic]]'']. Period."<ref name="ABC2">{{cite news | title=Experts call for regulation of baby gender tests | url=http://www.wfts.com/stories/2006/02/060220babyfolo.shtml | publisher=ABC Action News—Tampa | date=[[2006-02-20]] | accessdate=2007-01-16}}</ref> Yet in October 2005 he had stated his company had issued four refund checks, including one for a case involving a vanishing twin.<ref name="Newsweek"/> The PregnancyStore.com states that none of the refund checks were issued as a result of the test being proven wrong by a live birth. Their website states:
{{cquote|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.<ref name="NW-reply">{{cite web | url=http://www.pregnancystore.com/in_the_news.htm#NewsweekArticle |title=Pregnancy Store.com in the news! | work=PregnancyStore.com | accessdate=2006-07-18}}</ref>}}
In March 2006, Wang wrote 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 the results provided by Baby Gender Mentor should answer any concern about the accuracy of the test."<ref name="Revisit" />
Initial news reports and the Acu-Gen website touted a 200% money-back guarantee.<ref name="Newsweek"/> 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:
{{Cquote|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...<ref name="May-guarantee">{{cite web | url=http://babygendermentor.com/information.php?information_id=9 | title=Guarantee | work=Acu-Gen website | accessdate=2007-01-16}}</ref>}}
PregnancyStore.com also updated their website to state that the warranty was only 100% of the purchase price.<ref name="PregStore"/> In July 2006, the PregnancyStore.com reported that the test was "currently out of stock,"<ref name="PregStore" /> and In-Gender.com reported that the test has been completely pulled from the market.<ref>{{cite web | url=http://www.in-gender.com/cs/blogs/Gender_Selection_News/archive/2006/07/02/12855.aspx | title=India state plans to ban Baby Gender Mentor and other early prenatal gender tests | publisher=In-gender.com | date=[[July 2]] [[2006]] | accessdate=2007-01-19}}</ref> As of January 2007, PregnancyStore.com no longer contains any mention of the kit on their website,<ref>{{cite web | url=http://www.pregnancystore.com/ | title=Pregnancy Store: One-Stop Shop for Moms-to-Be | work=PregnancyStore.com | accessdate=2007-01-22}}</ref> although the Acu-Gen website does contain a form for on-line purchasing of the kit.<ref>{{cite web | url=http://babygendermentor.com/product.php?pid=1 | title=BGM TEST KIT: $25.00 (NOT Include $250.00 Lab Service Fee) | work=BabyGenderMentor.com | accessdate=2007-01-22}}</ref>
==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|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.<ref name="Boyce2" /> Acu-Gen does not mention a direct link to [[BioTronics]] in their marketing materials. However, they do state on their web-site that they utilize BioTronics' [[BioTronics|AmpliSensor]] technology.<ref name="BGM-Science"/> AmpliSensor is a real-time quantitative PCR assay invented by Wang and marketed by BioTronics.<ref name="BGM-Science"/><ref>{{cite web | url=http://www.biotech-register.com/listcogo.cfm?state=MA&company=Biotronics%5ECorporation&defn=POLYMERASE-CHAIN-REACTION&code=ASSA%20POJH | title=Biotronics corporation | work=Biotech-register.com | accessdate=2007-01-19}}</ref>
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."<ref name="ABC-concern" /> BioTronics does make a laboratory instrument known as an AG-9600 AmpliSensor Analyzer, which is used for [[quantitative]] DNA analysis.<ref>{{Cite patent|US|6033854}} Full text at:{{cite web | url=http://www.patentgenius.com/patent/6033854.html | title=U.S. Patent No 6,033,854—Quantitative PCR using blocking oligonucleotides | work=PatentGenius.com | authors=Kurnit, DM, Chiang PW, Wang CNJ.|date=[[March 7]] [[2000]] | accessdate=2007-01-21}}</ref>
It is not known whether the two [[journalism|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".<ref>{{cite web | url=http://babygendermentor.com/contactus.php | title=Contact us | work=BabyGenderMentor.com|accessdate=2007-05-09}}</ref> 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".<ref>{{cite web | url=http://tess2.uspto.gov/bin/showfield?f=doc&state=efvdko.2.1 | title=AmpliSensor | work=United States Patent and Trademark Office | accessdate=2007-01-21}}</ref>
==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.<ref name="Science-Mag" /> The other company is DNAPlus of [[Chatsworth, California]]. Both companies tests may be taken beginning at 10 weeks into the pregnancy as opposed to the five weeks given by Acu-Gen. Also both tests cost US$390, require a vial of fresh blood, and takes 10 business days to return results instead of the 48 hours needed by Acu-Gen.<ref>{{cite web | url=http://www.dnaplus.com/fetal_cell_prenatal_gender_test.htm | title=Fetal Cell/DNA Prenatal Gender Test—A Noninvasive Prenatal Gender Test Sampling Only the Mother's Blood | work=DNAPlus.com | accessdate=2007-01-21}}</ref> 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 [for testing]."<ref name="Globe" /> 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."<ref name="Globe" /> He also argues that parents can already conduct sex selection through other technologies, such as ultrasound.<ref name="Science-Mag" />
In April 2007 a test called "Pink or Blue" from the [[United Kingdom|British]] company DNA Worldwide became purchasable over the internet. Like Baby Gender Mentor, the Pink or Blue test looks for fetal DNA in the mother's blood.<ref>{{cite news | url= | title=Test can tell baby’s sex 6 weeks into pregnancy - Fetal DNA checked for Y chromosome; experts worry about ethics, accuracy | publisher=Associated Press | date=[[May 15]] [[2007]] | accessdate=2007-05-18}}</ref> 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.<ref>{{cite news | url=http://www.telegraph.co.uk/news/main.jhtml;jsessionid=01OGF1LTUHJS3QFIQMFCFF4AVCBQYIV0?xml=/news/2007/05/05/nbaby05.xml | title= Early baby sex test causes abortion fear | publisher=Telegraph | author=Womack, Sarah | date=[[May 5]][[2007]] | accessdate=2007-05-18}}</ref> 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 would launch an investigation into the Pink or Blue test.<ref>{{cite news | url=http://www.news.com.au/dailytelegraph/story/0,22049,21715528-5001021,00.html | title=Pick-your-baby test investigated | publisher=The Daily Telegraph | date=[[May 12]] [[2007]] | author=Masters, Clare | accessdate=2007-05-18}}</ref>
==References==
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==Further reading==
*{{cite book | last = Wang | first = CNJ | coauthors = Wu KY, Wang H | title = Quantitative PCR Using the AmpliSensor Assay. ''In:'' PCR Primer: A Laboratory Manual (Dieffenbach CW, Dveksler GS (eds) ) | pages= pp.193–202| publisher = Cold Spring Harbor Laboratory Press | year = 1995 | id = ISBN 978-0879694470}}
*{{cite patent|US|5348853}} "Method for reducing non-specific priming in DNA amplification", Wang CNJ, Wu KY. (1994).
*{{cite patent|US|5567583}} "Method for reducing non-specific priming in DNA detection", Wang CNJ, Wu KY. (1996).
*{{cite patent|US|5712386}} "Kits for detecting a nucleic acid with blocking oligonucleotides", Wang CNJ, Wu KY. (1998).
*{{cite patent|US|6033854}} "Quantitative PCR using blocking oligonucleotides", Kurnit, DM, Chiang PW, Wang CNJ. (2000).
==External links==
{{Spoken Wikipedia|Baby_Gender_Mentor.ogg|2008-05-27}}
*[http://babygendermentor.com/default.php Acu-Gen's Baby Gender Mentor webpage]
*[http://www.PregnancyStore.com PregnancyStore.com—Exclusive reseller of the Baby Gender Mentor test]
*[http://www.tufts.edu/sackler/facultyIntros/bianchiD.html Profile on Diana W. Bianchi, M.D.—Tufts]
*[http://www.bioethics.gov/background/background2.html President's Council on Bioethics—Briefing paper on sex selection]
*[http://www.tellmepinkorblue.com/ Pink or Blue - The New Gender Test]
*[http://www.consumergenetics.com/ Consumer Genetics - DNA Testing for You!]
*[http://www.dnapolicy.org/resources/2006_Javitt_Fertility_and_Sterility_Pink_or_Blue.pdf Pink or blue? The need for regulation is black and white]
{{featured article}}
[[Category:Birth control]]
[[Category:Reproduction]]
[[Category:Biotechnology products]]
[[Category:Laboratory techniques]]
[[Category:Medical ethics]]
[[Category:Molecular biology]]
[[Category:Pregnancy tests]]
[[om:Baby gender mentor]]