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.

In 2015, the Bloom Syndrome (BLM) test became the first direct-to-consumer genetic test to obtain marketing authorization from the FDA. This is just the beginning of a very exciting genetics revolution that will help genetics become an increasingly important part of our lives.

What we do

23andMe offers a, saliva-based, genotyping service that is available online for $199.

Samples are processed in a CLIA-certified and CAP-accredited lab.

More than 60 genetic 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, which enables consumers to learn about genetics and how it may impact their health and spark conversations about family health history.

View all reports

Methods

We use genotyping technology to look at specific genetic variants in the genome that can be most informative about an individual’s health and ancestry.

Unlike sequencing which analyses all nucleotides in a gene to identify changes, genotyping detects specific known variants within the genome. 23andMe uses a custom Illumina HumanOmniExpress-24 format chip that analyses approximately half a million variants. This custom chip has been designed to include variants:

  • In medically relevant genes
  • Involved in drug metabolism, efficacy and side effects
  • With known disease associations
  • Associated with traits
  • Used to assign genetic ancestry and ethnicity

Analytic validity

Our carrier status test results are analytically validated and meet FDA requirements.

Specific data on the analytic validity of the variants used in each report can be found on the scientific details page of each report.

23andMe is the first and only company that has received marketing authorization from the FDA for a direct-to-consumer genetic test. Accuracy of the Bloom Syndrome test was determined by comparing results from the BLM test with results from sequencing 70 samples. 70 out of 70 genotype results were correct. An additional study evaluated 105 samples at the same two laboratories. Both studies showed equivalent results in detecting carrier status of Bloom Syndrome when the same samples were tested.

View all reports

Clinical validity

We have established the clinical validity of our carrier tests based on FDA guidelines.

Clinical validity is the degree to which a test accurately identifies or predicts a disease of interest. For a variant to be eligible for inclusion in any of the 23andMe carrier reports, there must be sufficient evidence to establish the pathogenicity defined by:

  • inclusion in a least two clinical studies, and
  • functional evidence to support the pathogenicity of each variant and/or inclusion in professional society guidelines.

Prior to inclusion, each variant undergoes review by 23andMe’s scientific and medical teams to ensure that there is sufficient evidence to warrant inclusion.

Variant coverage

Variant coverage represents the proportion of disease-causing alleles in people with a given condition that would be detected by the test, sometimes referred to as the detection rate.

This varies by condition and within each condition it varies by ethnicity. For some conditions there is a single variant that accounts for all known cases of disease and our coverage is >99%. In other cases there are many variants that can cause the disease and we include some but not all of these on our assay. The coverage for specific ethnicities and the specific variants tested can be found in the scientific details section of each report.

View all reports

CLIA certification and CAP accreditation

23andMe laboratory testing is done in U.S. laboratories certified to meet CLIA (Clinical Laboratory Improvement Amendments of 1988) standards, including qualifications for individuals performing testing and other standards to ensure the accuracy and reliability of results. The laboratory is also accredited by the College of American Pathologists (CAP), which has served as a model for various federal, state, and private laboratory accreditation programs throughout the world.

Regulatory status

In 2015, 23andMe became the first and only company to receive marketing authorization for a direct-to-consumer genetic test for Bloom Syndrome.

The FDA has classified carrier status screening* as class II and created a regulatory path for autosomal recessive carrier status screening tests with similar uses. Thirty-five additional carrier status reports in the 23andMe experience also meet FDA standards. 23andMe will continue to seek FDA authorization to offer new reports.

Read further information on the FDA authorization

Privacy and security

Consumers choose how we use their genetic information and if and how it’s shared.

We take all efforts to make sure they have complete control over access to that sensitive information.

Because we believe that people should be protected against genetic discrimination, we encourage consumers to understand the extent of legal protection for their genetic information—in the U.S., under the Genetic Information Nondiscrimination Act (GINA) , a law that protects against employer and health insurance company discrimination based on your genetics, before they share it with anyone.

We strive to be responsible stewards of consumers’ information and to be as transparent as possible about our data use policies and practices. We’ve done our best to ensure information is protected by physical, technical, and administrative security measures.

Limitations associated with genetic raw data

We support open access to patient genetic information, but you and your patients should understand that there are limitations.

  • The data is suitable only for research, educational, and informational uses.
  • The data is not suitable for medical or other uses.
  • The raw data could include sensitive information. Within the raw data, your patients could discover sensitive information about themselves and the family members with whom they share their DNA. For example, comparing data between family members could reveal non-paternity.

Accelerating research

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.

Read more

*Our tests can be used to determine carrier status in adults, 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.

Join our education community

The 23andMe for Educators Program is designed to modernize genetics education in classrooms around the world. Registering gives educators access to the growing repository of crowd-sourced lessons, a discount on DNA kits, and email updates on new lessons and stories from the education community.