Large scale follow-up research study: SneakPeek® Early Gender DNA Test 99.9% accurate for fetal sex by live-birth confirmation
- International Journal of Pregnancy & Child Birth
Haley Milot, Alexa de Jerez, Chris Jacob
PDF Full Text
Early fetal sex determination has become more prevalent among parents interested in planning for their unborn child. 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. Here, we report the accuracy of the SneakPeek® Early Gender DNA Test from a large-scale clinical study of 1,029 pregnant women between 7 and 37 weeks of gestation (median =10 weeks). 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 the SneakPeek® Early Gender DNA Test. Venipuncture blood samples were collected from pregnant women in October through December of 2019, and subsequently analyzed with the SneakPeek® Early Gender DNA Test to determine fetal sex. After birth, a survey was conducted to obtain live birth information for all participants in the study. Y-chromosome DNA was detected in 505 of the 506 samples from mothers that gave birth to baby boys, providing 99.8% sensitivity. Gender of all 523 newborn girls was identified correctly, resulting in 100% specificity. There were no cases of male DNA contamination identified in this study (i.e. no false positives). 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. With 99.9% accuracy, SneakPeek® Early Gender DNA Test is the most reliable early fetal sex text available for expectant parents.
sneakPeek®, NIPT, pregnancy, fetal DNA, cell-free DNA, early gender test, live birth