Our rigorous quality standards:
- Our Carrier Status Tests meet FDA criteria for being scientifically and clinically valid*
- All saliva samples are processed in CLIA-certified and CAP-accredited labs
- Our DNA collection kit is FDA-cleared for use with our Carrier Status Tests and manufactured in accordance with FDA's Good Manufacturing Practice regulations
- Genotyping is a well-established and reliable platform for analyzing DNA
- Our team of scientists and medical experts uses a robust process to develop reports to ensure validity
*Our tests can be used to determine carrier status in adults from saliva collected using an FDA-cleared collection device (Oragene·DX model OGD-500.001), but cannot determine if you have two copies of the genetic variant. Each test is most relevant for people of certain ethnicities. The tests are not intended to diagnose a disease, or tell you anything about your risk for developing a disease in the future. On their own, carrier status tests are not intended to tell you anything about the health of your fetus, or your newborn child's risk of developing a particular disease later in life.
You are in control. You choose how your personal genetic information is used and shared with others. We tell you how those choices are implemented, and how we collect, use and disclose your information.
- We will not share your individual-level information to any third party without your explicit consent
- In accordance with the Genetic Information Nondiscrimination Act (GINA), a federal law put in place in 2008 to protect Americans from discrimination based on genetics, we will not give your information or results to health insurance companies or employers
- We have guidelines and policies in place to protect the personal information of children as well as incapacitated or deceased individuals
- We do not provide information to law enforcement unless required to comply with a valid subpoena or court order
Learn more about our privacy practices.
Human DNA is about 99.5% identical from person to person. However, there are small changes that make each person unique. These changes are called variants.
Your DNA was passed down from your parents — and their parents and so on. Variants can be linked to certain health conditions, traits and ancestry groups.
When it comes to your health and traits, your DNA is only part of the story. Other factors can come into play, including non-genetic factors such as your environment and lifestyle.
Your saliva contains DNA from cells in your mouth. We send you a saliva collection kit and instructions for providing your sample.
Our CLIA-certified lab extracts DNA from cells in your saliva sample. Then the lab processes the DNA on a genotyping chip that reads hundreds of thousands of locations in your genome.
Your genetic data is analyzed, and we generate your personalized reports based on well-established scientific and medical research.
To ensure quality, your DNA analysis is performed in US laboratories that are certified by CLIA (Clinical Laboratory Improvement Amendments of 1988) and accredited by the College of American Pathologists (CAP).
A CLIA-certified and CAP-accredited lab must meet certain quality standards, including qualifications for individuals who perform the test, and other standards that ensure the accuracy and reliability of results.
The analysis we perform is called genotyping. Our genotyping looks at hundreds of thousands of specific locations on your DNA. These locations are known to vary between individuals, and some are associated with certain conditions, traits, or ancestry.
We use leading technology to genotype your DNA — a custom Illumina HumanOmniExpress-24 format chip.