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Noninvasive prenatal testing (NIPT), also known as noninvasive prenatal screening (NIPS), can be used for a variety of medical procedures beneficial to an expecting mother. This includes identifying the risk of genetic abnormalities and determining the gender of the baby.
Traditionally, mothers could learn the gender of their babies via an ultrasound that usually made the determination between 18 and 20 weeks into the pregnancy. Later, a 3D ultrasound pushed that timeline to between 11 and 14 weeks of the first trimester.
What's in this Guide?
- Who created the SneakPeek test?
- What is the science underpinning the SneakPeek test?
- How to acquire and use the SneakPeek Early Gender DNA Test
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Even with this technology, first trimester sonography is considered fairly unreliable for sex determination 1. Until very recently, the only way to determine sex earlier in the first trimester was through invasive techniques, such as chorionic villus sampling, which can increase the risk of miscarriage.
However, Gateway Genomics’ new SneakPeek Early Gender DNA Test uses new technology and consumer genetics innovations to change the nature of noninvasive prenatal testing, allowing mothers to learn the gender of their babies as early as 9 weeks into the pregnancy 2. The reason such determinations are possible is because fragments of the baby’s fetal DNA, known as free-floating, cell-free DNA, or cfDNA, are released from the placenta and enter the mother’s circulatory system and bloodstream.
SneakPeek’s noninvasive prenatal test (NIPT) uses advanced technology to analyze these fetal DNA fragments in maternal capillary blood. By identifying the presence or absence of a Y chromosome--which indicates male gender--in the DNA, doctors can determine the gender of the baby much earlier and with an incredibly high rate of precision.
Such information allows the mother and family to prepare for the pregnancy with the knowledge of gender already established.
Who created the SneakPeek test?
Gateway Genomics, a La Jolla-based biotechnology company, developed SneakPeek in order to make prenatal gender testing available as an at-home test.
Gateway conducted a validation test that overturned twenty years of accepted science by showing that it is possible to determine a baby’s gender by testing maternal capillary blood as opposed to maternal venous blood 3. The company realized that the discovery would have wide-reaching beneficial effects on not only consumer genetics in general but DNA prenatal diagnosis specifically.
Gateway has since developed an advanced PCR (polymerase chain reaction) technology for home collection kits and a proprietary algorithm for testing prenatal gender. The developments mark a significant leap forward in consumer genetics.
Gateway’s technology makes a previously complex and expensive process accessible to millions more people. Many industry analysts view the studying of fetal DNA in maternal capillary blood as a major, game-changing discovery that will change the field of prenatal genetics.
It also holds potential in the detection of infectious disease and cancer.
In the coming years, this technology could also improve the detection of inherited diseases 4. There are approximately 10,000 single-gene inherited diseases that collectively influence nearly one in every 100 births.
Advances in noninvasive prenatal genetics could allow scientists to develop more effective methods for early diagnosis of diseases such as sickle cell anemia, haemophilia, and cystic fibrosis.
What is the science underpinning the SneakPeek test?
SneakPeek’s new early detection gender predictor test is bolstered by a series of scientific studies.
The first, entitled “Maternal capillary blood: A new source of circulating cell-free fetal DNA for noninvasive prenatal testing,” was published by the American Society of Human Genetics and is considered validation for not only the accuracy of a home DNA prenatal gender test but a proof-of-concept for whether such tests can be broadly accessible and affordable.
This study discussed one of the premises of the test’s development, which is that previously noninvasive prenatal testing (NIPT) was restricted to maternal venous blood extracted in the office of a trained phlebotomist 5.
Such a test required scheduling an appointment and conferring with insurance providers to make sure individual plans covered the procedure. This method, scientists believed, was limiting a broader adoption of such tests.
The goal then was to create a new method of NIPT that could detect fetal DNA by analyzing maternal capillary blood, thus allowing for the development of a simplified, low-cost test that can be used at home.
The study also noted that the original idea for using maternal plasma for NIPT dates back to 1997. Over twenty years later, SneakPeek now seeks to integrate this theory into a new technological model that allows expectant mothers to use a lancet finger stick to easily extract a blood sample in the comfort of their own home.
The study abstract concluded with the following:
“This new source of cell-free fetal DNA greatly simplifies the collection of maternal blood and has the potential to increase the accessibility of noninvasive prenatal testing. To our knowledge, this is the first study to show the isolation of cell-free fetal DNA and accurate gender determination from maternal capillary plasma.”
The statistical features of the study included factors such as Samples Analyzed, Female Fetuses, Male Fetuses, False Positives, False Negatives, Sensitivity, Specificity, Accuracy, and Inconclusive. By the end, all male fetuses were confirmed with Y-chromosome cell-free fetal DNA and the validation study showed that maternal capillary blood could be used for fetal gender determination.
The method was just as effective as the traditional venous blood analysis while offering the significant promise of greater accessibility to noninvasive prenatal testing.
A second study is described as a “Multicenter blinded study conducted at four ultrasound clinics in 2015 6.” Scientists collected maternal blood samples from pregnant women between 9 and 35 weeks of gestation.
“Real time quantitative PCR” was performed to analyze fetal DNA and “a multi-copy sequence on the Y chromosome.” Polymerase chain reaction (PCR) technology is widely used in molecular biology for creating replicas of a DNA sequence. SneakPeek registered a 100% accuracy rating in determining fetal gender.
This study was presented at the 19th conference of the International Society For Prenatal Diagnosis (ISPD) and concluded that “the results...demonstrate that fetal DNA detection using maternal capillary blood is highly feasible and easily adaptable for population screening. This method simplifies blood collection of maternal blood and should increase the accessibility of noninvasive prenatal testing.”
An even more recent study published in the Journal of Pregnancy and Child Health in 2017, called “Early Fetal Sex Determination using Cell-Free DNA in Micro-Volume of Maternal Plasma,” corroborated previous studies with an even larger sample size and greater clinic participation--241 women and 14 ultrasound clinics.
Once again real-time quantitative PCR was conducted on maternal blood samples to test for the presence of the Y chromosome.
Fetal sex was determined with a 99.6% accuracy rating--even higher than previous studies 7.
The science has been conclusive and resounding. Noninvasive prenatal DNA testing can be effectuated efficiently, accurately, cheaply, and without great strain or effort to the mother or family.
The SneakPeek early gender test marks the entry of this new research into the consumer genetics market with an at-home kit that allows families to take advantage of the latest advances in prenatal DNA scientific innovation.
How to acquire and use the SneakPeek Early Gender DNA Test
The SneakPeek test was specifically designed to be an easy, at-home test. The whole point was to allow people to enhance their family’s preparations with early gender determination that takes place without a costly and time-consuming visit to a phlebotomist.
Mothers can take the test 9 weeks after the first day of their Last Menstrual Period (LMP) or 31 weeks prior to their Estimated Due Date (EDD). Any gestational age earlier than 9 weeks will not be accepted 8.
Upon receiving the kit, one simply has to use the supplied finger stick to extract a small blood sample. Within 24 hours of receiving the sample, SneakPeek’s state of the art lab will analyze the fetal DNA in the sample and determine the gender.
Researchers believe that in addition to the efficiency and accuracy of a non-invasive at-home test, there are psychological benefits of early gender determination. A low-cost option that isn’t bogged down by physician appointments and insurance logistics, the SneakPeek early gender test affords accurate knowledge of your baby’s gender and can promote relaxation and family bonding.
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- Sonographic Fetal Sex Determination.
Odeh, Marwan MD; Grinin, Vitali MD; Kais, Mohamad MD; Ophir, Ella MD; Bornstein, Jacob MD. January 2009.
- SneakPeek® Science.
sneakpeektest.com. Gateway Genomics. 2019
- ISPD 19th International Conference Late-Breaking Abstracts.
International Society for Prenatal Diagnosis. July 2015.
- Simple blood test can detect genetic diseases early in pregnancy.
Alice Klein. New Scientist. 10 January 2017.
- Maternal capillary blood: A new source of circulating cell-free fetal DNA for noninvasive prenatal testing.
The American Society of Human Genetics.
- Multicenter blinded study conducted at four ultrasound clinics in 2015.
Multicenter Blinded Study of SneakPeak Early Gender Test. 2015.
- Early Fetal Sex Determination using Cell-Free DNA in Micro-Volume of Maternal Plasma.
Rachel Primacio, Haley Milot and Chris Jacob. Gateway Genomics, USA. 2017.
- Frequently asked questions.
sneakpeektest.com. Gateway Genomics. 2019.