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.