Gateway Genomics Launches SneakPeek® Early Gender Test and Shifts NIPT Testing to a Highly Affordable, Easy to Use At-Home Version

Validation Study Proves Accuracy of Home Version of DNA Prenatal
Gender Test and Enables Broad Accessibility

BALTIMORE–(BUSINESS WIRE)–Gateway Genomics demonstrates 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.

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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.

About:

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®
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Contacts

Gateway Genomics
Laura Hart, 858-886-7250
Public Relations
info@gatewaygenomics.org