Partnering with you to help people live healthier lives
Our mission is to help people access, understand and benefit from the human genome.
- We achieve this mission by making genetics accessible, affordable, simple and engaging to consumers. As the first and only company that has received marketing authorization from the FDA for a direct-to-consumer genetic test, we take our responsibility to our consumers, your patients, seriously.
- We recognize your important role in our consumers’ lives and we want to work in partnership with you to help people live healthier lives. To support you we have recruited a best in class medical team and are creating resources to guide you as genetics information is integrated into clinical practice.
- Genomics holds the promise of Health and Wellness, that is why we go beyond genetic testing, engaging our consumers in research with the goal of accelerating therapeutic development.
Welcome to 23andMe
There are few things more personal to all of us than our DNA.
Genetic information is core to our existence. It forms the basis for what makes us similar and unique. It has the potential to unlock ancestry, dictate traits, and influence health. 23andMe was founded with the mission of enabling people to access, understand, and benefit from this powerful information. Over the last nine years we have worked hard to make genetic information easily accessible, affordable, and simple enough for consumers of all education levels to understand, while being interesting enough for consumers to stay engaged and keep learning.
What we do
23andMe offers an over-the-counter, saliva-based, genotyping service that is available online for $199.
All samples are processed in a CLIA-certified and CAP-accredited lab. Over 60 reports are returned to our customers through a private and secure account online. The analysis includes information on carrier status*, wellness, genetic traits, and ancestry that enables consumers to learn about genetics and how it may impact their health and spark conversations about family health history.
For a list of reports currently included in our genotyping service, click here.
As 23andMe is able to clear new reports through the FDA and as knowledge of the genome advances, customers receive ongoing reports as part of our current service for no additional cost.
In 2015, 23andMe became the first and only company to receive marketing authorization for our direct-to-consumer genetic test for Bloom Syndrome.
Along with the authorization, FDA stated that they intended to classify autosomal recessive carrier status screening tests* as class II exempt, subject to general and special controls. As a result, 35 additional carrier status reports in the 23andMe experience meet these FDA standards. Moving forward, 23andMe will continue to seek FDA authorization of new reports within the carrier status and other categories.
For further information on the FDA authorization, click here .
Meet the 23andMe medical team
As part of our commitment to our consumers and you, we formed a team of some of the best and brightest people in genetics, medicine, and digital health.
Our 23andMe medical team members have published more than 200 peer-reviewed studies in scientific journals in just the last few years. In addition, they are involved in major medical societies as members and board members; they have trained, taught and worked at leading institutions; and they have decades of experience in both clinical settings and lab testing.
Consumer comprehension is one of our top priorities
People can only benefit from information if they understand it.
To ensure that our customers understand the meaning of their 23andMe carrier reports* without relying on a medical professional, we performed rigorous comprehension studies and met all FDA guidelines for consumer comprehension.
Our submission to the FDA for our Bloom Syndrome carrier status test* included a user comprehension study of a group that is representative of the general population of the United States. Results from the user comprehension study revealed that more than 90 percent of participants understood the test instructions and the Bloom Syndrome carrier status* test results.
We take our consumers' privacy and data security very seriously
Our consumers are in control of their genetic information.
At their discretion, our consumers can choose to authorize 23andMe to share their data with specific individuals, like their families, medical professionals or other institutions conducting disease research. We take all efforts to make sure they have complete control over access to their information.
We will not share your patients’ individual data without their explicit consent and we do not provide information to law enforcement unless required to comply with a valid subpoena or court order.
And we encourage your patients to understand the extent of their legal protection, under the United States’ Genetic Information Nondiscrimination Act (GINA) —a law that protects against employer and health insurance company discrimination based on one’s genetics.
23andMe customer data is protected by state-of-the-art physical, technical, and administrative security measures.
Accelerating Research. Making an Impact.
The 23andMe experience doesn’t end at genetic reports.
Through our innovative research platform we’ve been able to change the research paradigm and enable consumers to actively participate in genetic research. 23andMe has more than one million genotyped customers worldwide and over 80 percent have consented to participate in research. They have contributed over 300 million phenotypic data points, resulting in over 30 publications. Our research is conducted independently and in collaboration with third parties including leading academic institutions such as University of Chicago, the MRC Epidemiology Unit, University of Cambridge, Stanford University, and the Broad Institute of MIT and Harvard; industry such as Pfizer and Genentech; and non-profits such as the Lupus Research Institute, The Michael J Fox Foundation and the National Parkinson Foundation. Discoveries include a host of new disease genetic associations as well as understanding consumer comprehension of, and behaviors in response to, direct-to-consumer genetic test results.
The 23andMe Medical Professional Community is designed to help medical professionals better understand the 23andMe experience. By registering for the program, medical professionals will receive important updates from 23andMe, including notices about new features and upcoming educational programs, and opportunities to engage with 23andMe in a variety of ways (e.g., surveys, research, collaborations). You can also connect with a member of the 23andMe medical team.
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