![]() Inconclusive results were obtained for 3 pregnancies. ![]() Results: Male Y-chromosome was detected in all samples from participants carrying a male fetus. Test results from the 8 to 10-week gestation blood samples were used to confirm the 7-week test results. Maternal and fetal circulating free DNA (total cell-free DNA) was measured using an autosomal control gene. After extracting the cell-free DNA from these samples, real-time quantitative PCR was used to detect fetal DNA using a multi-copy sequence on the Y chromosome. Circulating cell-free DNA was isolated from maternal plasma using a DNA isolation kit for the 7- and 8 Plasma was separated from whole blood samples by centrifugation. ![]() In this study, 134 pregnant women consented to two blood draws: one draw at 7 weeks gestation and a second draw between 8- and 10-weeks’ gestation. Method: A multicenter non-randomized, controlled study was carried out at twelve healthcare clinics in the United States to assess the performance of the SneakPeek Early Gender Test for fetal sex identification at 7 weeks gestational age. The objective of this study was to evaluate SneakPeek’s clinical performance for noninvasive prenatal testing (NIPT) to determine fetal sex as early as 7 weeks gestation. The qPCR-based assay was further optimized to determine fetal sex at 7 weeks gestation. Background: Multiple studies have demonstrated SneakPeek® Early Gender Test’s ability to accurately determine fetal sex as early as 8 weeks gestation with greater than 99% accuracy.
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