Baby Gender Mentor

Background
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, or sex-selective abortion. 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, 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.

The company says that the accuracy of the test exceeds that of conventional methods, such as ultrasonography, amniocentesis, or chorionic villus sampling techniques, and that their test offers "unsurpassed accuracy, unrivaled earliness, and uncompromised promptness". However, they have not made public any clinical evidence to support these claims. Customers and scientists have questioned the accuracy of the test, and legal action is being pursued against Acu-Gen as well as a major supplier of the test.

Test methodology
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. 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 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. Results are posted to the company's website (with password-restricted access) within two business days.

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; 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 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."

Acu-Gen explains the test works by detecting fetal cells that have entered the woman's bloodstream through 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 males. If there is no Y chromosome, the embryo is female. 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.

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. In that show, Katie Couric interviewed a woman named Holly Osborn who 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 the president of a company called Mommy's Thinkin which is 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 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. She did not mention how these 2,000 pregnancies are related to the 20,000 pregnancies mentioned separately by Acu-Gen.

Osborn 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.

In The Today Show segment, Couric also interviewed Dr. Ronald Wapner, head of maternal fetal medicine at New York Presbyterian Hospital, who discussed possible pros and cons of the test. 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. 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 fetus.

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
At least 40 women have come forward to say their Baby Gender Mentor tests predicted the wrong sex. 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. 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. 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 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.

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." 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."

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 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."

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. Florida Congressman Jim Davis has urged the FDA to investigate Acu-Gen, and the Florida Attorney General has opened an investigation against Acu-Gen. 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 honor its money-back guarantee. The law firm cites seven areas of contention, including the veracity of the accuracy claims and the violation of HIPAA and other laws. 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 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".

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. KMSP-TV interviewed genetic counselor Dr. Analia Bortz who made the same prediction. 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.

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." According to Arthur Caplan, director of the 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. In China, sex selection has led to men outnumbering women by 55 to 45. 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. In a certain portion of New Delhi, only 762 girls were born per 1,000 boys. Punjab's Health Minister Ramesh Chander Dogra has said he will take action to ban the test in India.

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." Mutherson teaches tort law at Camden and her research interests include health law, family law, and bioethics.

The website for the PregnancyStore.com says that they will ship the tests only within the United States, though the test has been purchased by customers in Canada and in Scotland. 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?"

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. Acu-Gen's website specifically states that the test is not a medical test: 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.

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.

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." 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 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." 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. In this case, the woman delivered a healthy baby free from both Trisomy 18 and Down syndrome.

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 ambiguous genitalia. She later gave birth to a baby girl with normal female genitalia.

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".

Warranty and availability
Acu-Gen has allegedly created new requirements for people who want to take advantage of the money-back guarantee. 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.

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." Yet in October 2005 he had stated his company had issued four refund checks, including one for a case involving a vanishing twin. 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: 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 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."

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...

PregnancyStore.com also updated their website to state that the warranty was only 100% of the purchase price. In July 2006, the PregnancyStore.com reported that the test was "currently out of stock," and In-Gender.com reported that the test has been completely pulled from the market. 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. 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' AmpliSensor technology. AmpliSensor is a real-time quantitative PCR assay invented by Wang and marketed by BioTronics.

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." BioTronics does make a laboratory instrument known as an AG-9600 AmpliSensor Analyzer, which is used for quantitative DNA analysis.

It is not 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. 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. 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]." 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 sex selection through other technologies, such as ultrasound.

In April 2007 a test called "Pink or Blue" from the 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. 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. Australia's health minister, Tony Abbott, has said he would launch an investigation into the Pink or Blue test.