9+ WEEK GENDER DETERMINATION DNA BLOOD TEST
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Clinical Early Gender Blood Test
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Gender Prediction Starting at 9 Weeks into Pregnancy!
The Clinical 9+ Week Gender Blood Test utilizes the natural process of shared fetal DNA circulating inside the mother’s bloodstream. Our PCR technology has the ability to detect the presence or absence of male Y chromosome in the blood sample provided starting at 9 weeks into pregnancy. If it is detected then the baby’s gender is male and if it is not detected then the baby’s gender is female.
|9-12 week (n,%)||77 (57.04%)|
|13-27 week (n,%)||53 (39.26%)|
|≥28 week (n,%)||5 (3.70%)|
Multicenter blinded study conducted at four ultrasound clinics in 2015. The purpose of this study was to assess the clinical performance of SneakPeek® Early Gender Test (Gateway Genomics) for noninvasive prenatal testing (NIPT) of fetal sex. A multicenter-blinded study was conducted at four ultrasound clinics with maternal blood samples collected from pregnant women between 9 and 35 weeks of gestation. Circulating cell-free DNA was isolated from a micro-volume of maternal plasma and real-time quantitative PCR was performed to detect fetal DNA using a multi-copy sequence on the Y chromosome. An autosomal control gene was used to measure total cell-free DNA (maternal and fetal cfDNA). Sixty maternal plasma samples were tested twice, on different days, to assess the precision of SneakPeek.
Cell-free DNA was detected in all maternal blood samples. Y-chromosome DNA was detected in all samples from women carrying a male fetus. SneakPeek correctly identified fetal sex in all samples. Assay precision data showed minimal variation and high reproducibility of results. Fetal sex for all samples was unknown prior to genetic testing and was confirmed via sonographic evaluation at the conclusion of the study. SneakPeek accuracy, sensitivity and specificity were each 100% for fetal sex identification. This blinded study showed that SneakPeek Early Gender Test is highly accurate for fetal sex determination in early pregnancy.
Gestational Age of the 135 Pregnant Participants