![]() ![]() 9,10,16, 4,20 During the COVID19 pandemic, many elective ultrasound locations were closed, health practitioner visits moved to a telehealth setting, and many pregnant women did not feel comfortable visiting a clinic. Furthermore, fetal sex determination has been shown to confer benefits to both the parents and to the unborn child as prenatal knowledge of the fetus’s sex is correlated to prenatal care seeking behavior. These reasons include childbearing preparations, the desire for a closer emotional attachment to the fetus and bestowing a sense of personhood and social identity upon the fetus instead of using gender neutral pronouns such as “it”. 9,10 Expecting parents’ motivation for learning their fetus’ sex originates from not only medical concerns but also nonmedical and social reasons. Several studies have shown that over 50% of women and their partners wish to know the sex of their child before birth. 6,12,16–19 Compared to other methods available to parents, SneakPeek ® is the most accessible, affordable, and accurate choice for fetal sex determination.7 Demand to learn the fetus’ sex prior to childbirth has increased. 5,10,14,15 With a small blood sample, parents can learn gender sooner, more reliably, and less expensively than ultrasound anatomy scans or other non-invasive prenatal tests. With high consumer expectations and increased access to information, parents want to learn the sex of their fetus earlier in pregnancy. Accessibility to high-quality genetic testing for prospective parents to learn the sex of their fetus has been substantially improved due to the affordability and reliability of SneakPeek®compared to other methods for predicting fetal sex such as ultrasound anatomy scans, chorionic villus sampling, and amniocentesis. 7 In this large-scale follow up study, live birth data from more than 1,000 study participants demonstrated that SneakPeek® is 99.9% accurate for fetal sex identification. In a prior study with fewer samples, SneakPeek® was shown to determine fetal sex at 8 weeks gestation with 99.1% accuracy. can offer high confidence in its test results by leveraging the highest quality data validation to confirm their high accuracy claims – live birth confirmation. In this study, we sought to show that the SneakPeek®Early Gender DNA Test (“SneakPeek”). 1–6 Credible and accurate inputs are crucial to the quality of the data output which plays a large role in the success of a given genetic test. A plethora of non-invasive prenatal tests (NIPT) have been developed, however there are only a handful of clinical studies that are robust enough to show real-world accuracy, with most studies reporting on fewer than 1,000 total patient samples. The biotech industry has been responsible for many technological advancements within molecular-based prenatal tests and validating information obtained from these advanced techniques is essential to demonstrate the accuracy of these new tests. Keywords: sneakPeek®, NIPT, pregnancy, fetal DNA, cell-free DNA, early gender test, live birth Introduction With 99.9% accuracy, SneakPeek® is the most reliable early fetal sex text available for expectant parents. In the largest qPCR-based fetal sex test study to date, SneakPeek® test results were confirmed using the gold standard of the baby’s sex at birth. There were no cases of male DNA contamination identified in this study (i.e. Gender of all 523 newborn girls was identified correctly, resulting in 100% specificity. Y-chromosome DNA was detected in 505 of the 506 samples from mothers that gave birth to baby boys, providing 99.8% sensitivity. After birth, a survey was conducted to obtain live birth information for all participants in the study. Venipuncture blood samples were collected from pregnant women in October through December of 2019, and subsequently analyzed with SneakPeek® to determine fetal sex. A follow-up survey was conducted on all study participants to determine whether the birth sex of their child matched the fetal sex test result reported by SneakPeek®. Here, we report the accuracy of SneakPeek® from a large-scale clinical study of 1,029 pregnant women between 7 and 37 weeks of gestation (median =10 weeks). Current advances in non-invasive prenatal testing (NIPT) have facilitated this desire with safe and efficient methods such as the SneakPeek ® Early Gender DNA Test (“SneakPeek”). Received: Novem| Published: December 29, 2020Įarly fetal sex determination has become more prevalent among parents interested in planning for their unborn child. Haley Milot, Alexa de Jerez, Chris Jacob Gateway Genomics, San Diego, California, USAĬorrespondence: Haley Milot, Gateway Genomics, San Diego, California, USA, Email ![]()
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