Validation Study Proves Accuracy of Home Version of DNA Prenatal Gender Test and Enables Broad AccessibilityOctober 08, 2015 05:33 PM Eastern Daylight Time
BALTIMORE–(BUSINESS WIRE)–Gateway Genomicsdemonstrates the accuracy of its advanced prenatal technology in a validation study showcased at the American Society of Human Genetics Conference. After previously overcoming a twenty-year roadblock of current non-invasive maternal venous blood collection by proving it is possible to accurately determine gender from maternal capillary blood, they have now made the technology available to the public in an at-home test.
Click to Tweet: Gateway Genomics Launches SneakPeek® Early Gender Test and Shifts NIPT Testing to a Highly Affordable, Easy to Use At-Home Version
Gateway conducted a validation study to show that at-home collection of capillary blood using their new consumer product SneakPeek® Early Gender Test could be used to accurately determine the gender of the fetus. Capillary blood samples were collected from 153 pregnant women (6-24 weeks gestation) using SneakPeek® sample collection kits. Plasma was separated from capillary blood via centrifugation and cell-free DNA was extracted and purified using a commercial DNA extraction kit. Following isolation of cell-free DNA, real-time quantitative PCR was performed to detect the presence of male cell-free fetal DNA using a multi-copy target sequence on the Y chromosome. In addition to the Y-target, an endogenous control gene was used to measure the amount of total cell-free DNA (maternal and fetal) present in the sample to ensure there was a sufficient amount for processing. Gender calls were made using the SneakPeek® algorithm that incorporates Ct values of the Y-target sequence and endogenous control gene. Participants confirmed gender results via ultrasound, CVS, or NIPT yielding a 98% accuracy rate for the SneakPeek® algorithm.
Overcoming the limitations of non-invasive prenatal diagnostics was Gateway’s first step in paving the way for the next trend in consumer genetics, fast and affordable at-home genetic testing. The new technology allows for the ability to collect blood samples almost anywhere and initiated the launch of a consumer application now available as a self-collection kit under the SneakPeek® brand. The validation study presented at ASHG shows that SneakPeek® Early Gender Test is highly accurate at determining baby gender as early as 9 weeks into pregnancy.
Gateway Genomics’ laboratory services and genetic tests are being developed to provide faster and more affordable at-home genetic tests to the general population. For more information visit the company’s websites at SneakPeek® Test, Facebook, Twitter, Pinterest, and Instagram.