23andMe genetic reports

Carrier Status*, Ancestry, Traits and Wellness

Take a look at our sample genetic reports and discover what consumers are learning about themselves and their genetics. Some of our customers could be your patients, and they may want to discuss their reports with you.

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23andMe Carrier Status Tests:
What you should know

Carrier status
tests detect genetic variants that can cause inherited conditions. These variants are often found primarily in certain ethnicities.

Being a carrier
means your patient has one variant for the condition. Carriers typically don’t have the condition but can pass the variant to their children.

Knowing your patient’s carrier status
 may be important if he or she is planning a family. If your patient and his or her partner are both carriers, they have a 25% chance to have a child with the condition. If your patient is beyond reproductive age, it may be useful for him or her to share their carrier status results with family members, as they may also be carriers.

Genetic counseling
 can help your patient understand his or her results and options.

When to refer your patient to a genetic counselor

We encourage our customers to learn more so they can decide whether testing is right for them.

A Genetic Counselor, a health professional with special training in genetic conditions, will be able to answer your patients’ specific questions and help them make informed decisions about testing.

Read More

Analytic validity

23andMe is the first and only company that has received marketing authorization from the FDA for a direct-to-consumer genetic test.

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.

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Clinical validity

We have established the clinical validity of our carrier status 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 status reports, there must be sufficient evidence to establish the pathogenicity defined by:

  • Inclusion in at 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.


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.

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.

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