Baby Gender Mentor is the trade name

Trade name

A trade name, also known as a trading name or a business name, is the name which a business trades under for commercial purposes, although its registered, legal name, used for contracts and other formal situations, may be another....

 of a controversial blood test

Blood test

A blood test is a laboratory analysis performed on a blood sample that is usually extracted from a vein in the arm using a needle, or via fingerprick....

 designed for prenatal sex discernment

Prenatal sex discernment

Prenatal sex discernment is the prenatal testing for discerning the sex of a fetus before birth.-Methods:Prenatal sex discernment can be performed by preimplantation genetic diagnosis before conception....

, that is, to determine whether a pregnant

Pregnancy

Pregnancy refers to the fertilization and development of one or more offspring, known as a fetus or embryo, in a woman's uterus. In a pregnancy, there can be multiple gestations, as in the case of twins or triplets...

 woman is carrying a male or female child. The test is made by Acu-Gen Biolab, Inc., a biotech

Biotechnology

Biotechnology is a field of applied biology that involves the use of living organisms and bioprocesses in engineering, technology, medicine and other fields requiring bioproducts. Biotechnology also utilizes these products for manufacturing purpose...

 company in Lowell, Massachusetts

Lowell, Massachusetts

Lowell is a city in Middlesex County, Massachusetts, USA. According to the 2010 census, the city's population was 106,519. It is the fourth largest city in the state. Lowell and Cambridge are the county seats of Middlesex County...

, United States

United States

The United States of America is a federal constitutional republic comprising fifty states and a federal district...

, and is marketed to detect the sex of a fetus

Fetus

A fetus is a developing mammal or other viviparous vertebrate after the embryonic stage and before birth.In humans, the fetal stage of prenatal development starts at the beginning of the 11th week in gestational age, which is the 9th week after fertilization.-Etymology and spelling variations:The...

 as early as five weeks after conception

Fertilisation

Fertilisation is the fusion of gametes to produce a new organism. In animals, the process involves the fusion of an ovum with a sperm, which eventually leads to the development of an embryo...

. The test made a prominent media debut on 17 June 2005 on The Today Show and it was featured in Newsweek in October 2005. 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

Amniocentesis

Amniocentesis is a medical procedure used in prenatal diagnosis of chromosomal abnormalities and fetal infections, in which a small amount of amniotic fluid, which contains fetal tissues, is sampled from the amnion or amniotic sac surrounding a developing fetus, and the fetal DNA is examined for...

 and ultrasound

Ultrasound

Ultrasound is cyclic sound pressure with a frequency greater than the upper limit of human hearing. Ultrasound is thus not separated from "normal" sound based on differences in physical properties, only the fact that humans cannot hear it. Although this limit varies from person to person, it is...

. 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, sex-selective abortion. The Baby Gender Mentor test is not regulated by the FDA, nor approved for diagnosis of any disease.

According to the Baby Gender Mentor web site, the test involves using real-time polymerase chain reaction

Real-time polymerase chain reaction

In molecular biology, real-time polymerase chain reaction, also called quantitative real time polymerase chain reaction or kinetic polymerase chain reaction , is a laboratory technique based on the PCR, which is used to amplify and simultaneously quantify a targeted DNA molecule...

 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.

Customers and scientists have questioned the accuracy of the test, and legal action

Lawsuit

A lawsuit or "suit in law" is a civil action brought in a court of law in which a plaintiff, a party who claims to have incurred loss as a result of a defendant's actions, demands a legal or equitable remedy. The defendant is required to respond to the plaintiff's complaint...

 is being pursued against Acu-Gen as well as a major supplier of the test. The lawsuits claim that Acu-Gen's products are inaccurate with babies having their sex confirmed with ultrasounds and at birth. In their defense, Acu-Gen replied that ultrasounds were incorrect and that some of the babies had gender abnormalities.

Test methodology

Acu-Gen 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$

United States dollar

The United States dollar , also referred to as the American dollar, is the official currency of the United States of America. It is divided into 100 smaller units called cents or pennies....

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.

The regulatory hurdles that apply to pharmaceutical

Pharmaceutical company

The pharmaceutical industry develops, produces, and markets drugs licensed for use as medications. Pharmaceutical companies are allowed to deal in generic and/or brand medications and medical devices...

 products and diagnostic tests do not apply to the Baby Gender Mentor test because it does not diagnose, prevent or treat a disease. In particular, Acu-Gen is not obliged to disclose results of any tests or patient trials

Clinical trial

Clinical trials are a set of procedures in medical research and drug development that are conducted to allow safety and efficacy data to be collected for health interventions...

 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 birth

Birth

Birth is the act or process of bearing or bringing forth offspring. The offspring is brought forth from the mother. The time of human birth is defined as the time at which the fetus comes out of the mother's womb into the world...

s, but that the company "won't publish results until it has patented its technology".

The PCR technique monitors the level of fluorescence energy transfer between nested primers

Primer (molecular biology)

A primer is a strand of nucleic acid that serves as a starting point for DNA synthesis. They are required for DNA replication because the enzymes that catalyze this process, DNA polymerases, can only add new nucleotides to an existing strand of DNA...

 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

DNA

Deoxyribonucleic acid is a nucleic acid that contains the genetic instructions used in the development and functioning of all known living organisms . The DNA segments that carry this genetic information are called genes, but other DNA sequences have structural purposes, or are involved in...

 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

Warranty

In business and legal transactions, a warranty is an assurance by one party to the other party that specific facts or conditions are true or will happen; the other party is permitted to rely on that assurance and seek some type of remedy if it is not true or followed.In real estate transactions, a...

 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

Katie Couric

Katherine Anne "Katie" Couric is an American journalist and author. She serves as Special Correspondent for ABC News, contributing to ABC World News, Nightline, 20/20, Good Morning America, This Week and primetime news specials...

 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

Illinois

Illinois is the fifth-most populous state of the United States of America, and is often noted for being a microcosm of the entire country. With Chicago in the northeast, small industrial cities and great agricultural productivity in central and northern Illinois, and natural resources like coal,...

-based on-line retailer where Osburn purchased her 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.

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.

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. 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.

The test was listed as one of the top 10 innovations of 2005 by research company DataMonitor

Datamonitor

Datamonitor is an international company providing market intelligence, data analysis and opinion via a worldwide network of in-house analysts. According to the organization's website in 2011, Datamonitor assists over 6000 of the world’s leading corporations in making strategic and operational...

. 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

Vanishing twin

A vanishing twin, also known as fetal resorption, is a fetus in a multi-gestation pregnancy which dies in utero and is then partially or completely reabsorbed by the mother or twin....

, a fetus that stopped growing soon after fertilization. Vanishing Twin Syndrome occurs when one of the fetuses in a twin

Twin

A twin is one of two offspring produced in the same pregnancy. Twins can either be monozygotic , meaning that they develop from one zygote that splits and forms two embryos, or dizygotic because they develop from two separate eggs that are fertilized by two separate sperm.In contrast, a fetus...

 pregnancy spontaneously aborts, usually during the first trimester. The fetal tissue is absorbed by either the other twin, the placenta

Placenta

The placenta is an organ that connects the developing fetus to the uterine wall to allow nutrient uptake, waste elimination, and gas exchange via the mother's blood supply. "True" placentas are a defining characteristic of eutherian or "placental" mammals, but are also found in some snakes and...

, 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

Scientific evidence

Scientific evidence has no universally accepted definition but generally refers to evidence which serves to either support or counter a scientific theory or hypothesis. Such evidence is generally expected to be empirical and properly documented in accordance with scientific method such as is...

 cited by Acu-Gen's web site is a paper co-authored by Diana Bianchi, an expert on fetal DNA

DNA

Deoxyribonucleic acid is a nucleic acid that contains the genetic instructions used in the development and functioning of all known living organisms . The DNA segments that carry this genetic information are called genes, but other DNA sequences have structural purposes, or are involved in...

 at Tufts University

Tufts University

Tufts University is a private research university located in Medford/Somerville, near Boston, Massachusetts. It is organized into ten schools, including two undergraduate programs and eight graduate divisions, on four campuses in Massachusetts and on the eastern border of France...

. 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

Caveat emptor

Caveat emptor is Latin for "Let the buyer beware". Generally, caveat emptor is the property law doctrine that controls the sale of real property after the date of closing.- Explanation :...

. Let the buyer beware." Another criticism has come from Sandra Carson, professor of obstetrics and gynecology

Obstetrics and gynaecology

Obstetrics and gynaecology are the two surgical–medical specialties dealing with the female reproductive organs in their pregnant and non-pregnant state, respectively, and as such are often combined to form a single medical specialty and postgraduate training programme...

 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." Carson at that time was at the Baylor College of Medicine

Baylor College of Medicine

Baylor College of Medicine, located in the Texas Medical Center in Houston, Texas, USA, is a highly regarded medical school and leading center for biomedical research and clinical care...

. Dr. Charles Lockwood, chairman of obstetrics and gynecology at Yale School of Medicine

Yale School of Medicine

The Yale School of Medicine at Yale University is a private medical school located in New Haven, Connecticut, U.S. It was founded in 1810 as The Medical Institution of Yale College, and formally opened its doors in 1813....

, 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" and the president of Acu-Gen said the suit was "totally bogus".

There are multiple legal challenges and investigations under way. Gail O'Conner, a spokesperson for the Illinois

Illinois

Illinois is the fifth-most populous state of the United States of America, and is often noted for being a microcosm of the entire country. With Chicago in the northeast, small industrial cities and great agricultural productivity in central and northern Illinois, and natural resources like coal,...

 State Attorney General

State Attorney General

The state attorney general in each of the 50 U.S. states and territories is the chief legal advisor to the state government and the state's chief law enforcement officer. In some states, the attorney general serves as the head of a state department of justice, with responsibilities similar to those...

, says that they are investigating PregnancyStore.com for possible fraud

Fraud

In criminal law, a fraud is an intentional deception made for personal gain or to damage another individual; the related adjective is fraudulent. The specific legal definition varies by legal jurisdiction. Fraud is a crime, and also a civil law violation...

. Florida

Florida

Florida is a state in the southeastern United States, located on the nation's Atlantic and Gulf coasts. It is bordered to the west by the Gulf of Mexico, to the north by Alabama and Georgia and to the east by the Atlantic Ocean. With a population of 18,801,310 as measured by the 2010 census, it...

 Congressman

United States House of Representatives

The United States House of Representatives is one of the two Houses of the United States Congress, the bicameral legislature which also includes the Senate.The composition and powers of the House are established in Article One of the Constitution...

 Jim Davis

Jim Davis (politician)

James Oscar "Jim" Davis III is an American politician from the U.S. state of Florida. He is a Democrat and served in the U.S. House of Representatives from 1997 to 2007, representing Florida's 11th congressional district...

 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

Class action

In law, a class action, a class suit, or a representative action is a form of lawsuit in which a large group of people collectively bring a claim to court and/or in which a class of defendants is being sued...

 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

False advertising

False advertising or deceptive advertising is the use of false or misleading statements in advertising. As advertising has the potential to persuade people into commercial transactions that they might otherwise avoid, many governments around the world use regulations to control false, deceptive or...

 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.

Possible uses for test

Parents have cited an interest in preparing themselves or the baby's siblings for gender-specific

Gender role

Gender roles refer to the set of social and behavioral norms that are considered to be socially appropriate for individuals of a specific sex in the context of a specific culture, which differ widely between cultures and over time...

 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.

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 a sex-selective abortion

Sex-selective abortion

Sex-selective abortion is the practice of terminating a pregnancy based upon the predicted sex of the baby. The selective abortion of female fetuses is most common in areas where cultural norms value male children over female children, especially in parts of People's Republic of China, India,...

. KMSP-TV

KMSP-TV

KMSP-TV, channel 9, is the Fox-owned-and-operated television station serving the Minneapolis-Saint Paul, Minnesota designated market area, owned in a duopoly with MyNetworkTV affiliate WFTC...

 interviewed genetic counselor

Genetic counseling

Genetic counseling or traveling is the process by which patients or relatives, at risk of an inherited disorder, are advised of the consequences and nature of the disorder, the probability of developing or transmitting it, and the options open to them in management and family planning...

 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

Americans United for Life

Americans United for Life is an American pro-life public interest law firm and advocacy group based in Washington, D.C. Founded in 1971, the group advocates protection of human life at all stages of life, from conception to death, and is involved in related issues of health and biotechnology...

 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

Bioethics

Bioethics is the study of controversial ethics brought about by advances in biology and medicine. Bioethicists are concerned with the ethical questions that arise in the relationships among life sciences, biotechnology, medicine, politics, law, and philosophy....

 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

Arthur Caplan

Arthur L. Caplan, Ph.D., is Emmanuel and Robert Hart Professor of Bioethics and director of the Center for Bioethics at the University of Pennsylvania. Prior to coming to Penn in 1994, Caplan taught at the University of Minnesota, the University of Pittsburgh, and Columbia University. He was the...

, director of the Center for Bioethics at the University of Pennsylvania

University of Pennsylvania School of Medicine

The Perelman School of Medicine , formerly the University of Pennsylvania School of Medicine, was founded in 1765, making it the oldest American medical school. As part of the University of Pennsylvania, it is located in the University City section of Philadelphia, Pennsylvania. It is widely...

, sex selection is not a frequent occurrence in the United States

United States

The United States of America is a federal constitutional republic comprising fifty states and a federal district...

 but it is a concern in countries such as India and China, where having boys is preferred over having girls. In China, sex selection has led to men outnumbering women by about 1.2-to-1. 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

New Delhi

New Delhi is the capital city of India. It serves as the centre of the Government of India and the Government of the National Capital Territory of Delhi. New Delhi is situated within the metropolis of Delhi. It is one of the nine districts of Delhi Union Territory. The total area of the city is...

, 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.

The website for the PregnancyStore.com says that they will ship the tests only within the United States, Sheila McLean

Sheila McLean

Professor Sheila Ann Manson McLean, FRSE, FRCPE, FRCGP, FRSA is International Bar Association Professor of Law and Ethics in Medicine and director of the Institute of Law and Ethics in Medicine at the School of Law of the University of Glasgow...

, professor of medical ethics

Medical ethics

Medical ethics is a system of moral principles that apply values and judgments to the practice of medicine. As a scholarly discipline, medical ethics encompasses its practical application in clinical settings as well as work on its history, philosophy, theology, and sociology.-History:Historically,...

 at Glasgow University, is critical of the kits.

Alleged use for medical diagnoses

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

Genetic disorder

A genetic disorder is an illness caused by abnormalities in genes or chromosomes, especially a condition that is present from before birth. Most genetic disorders are quite rare and affect one person in every several thousands or millions....

 such as Down syndrome

Down syndrome

Down syndrome, or Down's syndrome, trisomy 21, is a chromosomal condition caused by the presence of all or part of an extra 21st chromosome. It is named after John Langdon Down, the British physician who described the syndrome in 1866. The condition was clinically described earlier in the 19th...

. 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

Edwards syndrome

Trisomy 18 is a genetic disorder caused by the presence of all or part of an extra 18th chromosome. It is named after John H. Edwards, who first described the syndrome in 1960...

. 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

X chromosome

The X chromosome is one of the two sex-determining chromosomes in many animal species, including mammals and is common in both males and females. It is a part of the XY sex-determination system and X0 sex-determination system...

 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, a woman may seek to have an amniocentesis or other invasive procedure

Invasive procedure

Invasive procedure may refer to:* "Invasive Procedures" , the fourth episode of the second season of the television series Star Trek: Deep Space Nine* Invasive Procedures , a 2007 novel by Orson Scott Card and Aaron Johnston...

 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.

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

Emotional distress

Mental distress or anxiety suffered as a response to a sudden, severe, and saddening experience.Emotional distress may refer to:* Law of torts:** Intentional infliction of emotional distress** Negligent infliction of emotional distress* Medicine:...

 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

Birth certificate

A birth certificate is a vital record that documents the birth of a child. The term "birth certificate" can refer to either the original document certifying the circumstances of the birth or to a certified copy of or representation of the ensuing registration of that birth...

. He's making them get blood tests from the newborn baby

Infant

A newborn or baby is the very young offspring of a human or other mammal. A newborn is an infant who is within hours, days, or up to a few weeks from birth. In medical contexts, newborn or neonate refers to an infant in the first 28 days after birth...

. 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 . 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

Live birth

In human reproduction, a live birth occurs when a fetus, whatever its gestational age, exits the maternal body and subsequently shows any sign of life, such as voluntary movement, heartbeat, or pulsation of the umbilical cord, for however brief a time and regardless of whether the umbilical cord or...

. Their website states:
In March 2006, Wang wrote in an e-mail

E-mail

Electronic mail, commonly known as email or e-mail, is a method of exchanging digital messages from an author to one or more recipients. Modern email operates across the Internet or other computer networks. Some early email systems required that the author and the recipient both be online at the...

 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, Baby Gender Mentor 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:
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, a commercial sales blog, reported that the test has been completely pulled from the market in India. As of January 2007, PregnancyStore.com no longer contains any mention of the kit on their website, although the BabyGenderMentor.com 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

Hindu

Hindu refers to an identity associated with the philosophical, religious and cultural systems that are indigenous to the Indian subcontinent. As used in the Constitution of India, the word "Hindu" is also attributed to all persons professing any Indian religion...

 and a company called BioTronics

BioTronics

BioTronics is a biotech company headquartered in Lowell, Massachusetts in the United States. The company is the developer of the AmpliSensor technique and its application to high resolution Polymerase Chain Reaction assays....

, 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

BioTronics

BioTronics is a biotech company headquartered in Lowell, Massachusetts in the United States. The company is the developer of the AmpliSensor technique and its application to high resolution Polymerase Chain Reaction assays....

 in their marketing materials. However, they do state on their web-site that they utilize BioTronics' AmpliSensor

BioTronics

BioTronics is a biotech company headquartered in Lowell, Massachusetts in the United States. The company is the developer of the AmpliSensor technique and its application to high resolution Polymerase Chain Reaction assays....

 technology, according to the Baby Gender Mentor website. AmpliSensor is a real-time quantitative PCR assay invented by Wang and marketed by BioTronics, according to the Baby Gender Mentor website.

A news crew from television station WFTS, an American Broadcasting Company

American Broadcasting Company

The American Broadcasting Company is an American commercial broadcasting television network. Created in 1943 from the former NBC Blue radio network, ABC is owned by The Walt Disney Company and is part of Disney-ABC Television Group. Its first broadcast on television was in 1948...

 (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

Laboratory equipment

Laboratory equipment refers to the various tools and equipment used by scientists working in a laboratory. These include tools such as Bunsen burners, and microscopes as well as speciality equipment such as operant conditioning chambers, spectrophotometers and calorimeters...

 known as an AG-9600 AmpliSensor Analyzer, which is used for quantitative

Quantitative property

A quantitative property is one that exists in a range of magnitudes, and can therefore be measured with a number. Measurements of any particular quantitative property are expressed as a specific quantity, referred to as a unit, multiplied by a number. Examples of physical quantities are distance,...

 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

Trademark

A trademark, trade mark, or trade-mark is a distinctive sign or indicator used by an individual, business organization, or other legal entity to identify that the products or services to consumers with which the trademark appears originate from a unique source, and to distinguish its products or...

 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".

External links

• Official website
• Profile on Diana W. Bianchi.
• President's Council on Bioethics—Briefing paper on sex selection
• Pink or blue? The need for regulation is black and white. Genetics & Public Policy Center. Johns Hopkins University
  Johns Hopkins University
  The Johns Hopkins University, commonly referred to as Johns Hopkins, JHU, or simply Hopkins, is a private research university based in Baltimore, Maryland, United States...
  
  . Berman Institute of Bioethics