23andMe is CLIA certified and FDA authorized, and makes many medical claims. From [1]:
"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."
FDA authorizations for 23andMe's personal genome service are available online, e.g. [2] for Alzheimer's disease risk reporting based on the E4 variant of the APOE gene.
The company also offers ancestry reports, which are not clinical and thus covered by CLIA. But medical claims in 23andMe's health reports do comply with CLIA and other regulations.
"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."
FDA authorizations for 23andMe's personal genome service are available online, e.g. [2] for Alzheimer's disease risk reporting based on the E4 variant of the APOE gene.
The company also offers ancestry reports, which are not clinical and thus covered by CLIA. But medical claims in 23andMe's health reports do comply with CLIA and other regulations.
1. https://medical.23andme.com/dna-kits/#clia
2. https://www.accessdata.fda.gov/cdrh_docs/pdf16/DEN160026.pdf