Baby Sex
Baby Sex
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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, 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 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 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.
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$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 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 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".
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.
The test was featured on an episode of The Today Show in June 2005.[dead link] 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 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.[dead link] She did not mention how these 2,000 pregnancies are related to the 20,000 pregnancies mentioned separately by Acu-Gen.[dead link][not in citation given]
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.[dead link]
In The Today Show segment, Couric also interviewed Dr. Ronald Wapner, head of maternal fetal medicine at New York Presbyterian Hospital,[not in citation given] who discussed possible pros and cons of the test.[dead link] 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.[dead link]
According to the Baby Gender Mentor 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.
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. 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.
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$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 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 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".
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.
The test was featured on an episode of The Today Show in June 2005.[dead link] 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 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.[dead link] She did not mention how these 2,000 pregnancies are related to the 20,000 pregnancies mentioned separately by Acu-Gen.[dead link][not in citation given]
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.[dead link]
In The Today Show segment, Couric also interviewed Dr. Ronald Wapner, head of maternal fetal medicine at New York Presbyterian Hospital,[not in citation given] who discussed possible pros and cons of the test.[dead link] 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.[dead link]
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