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Federal law requires that labs retain the results of genetic testing for a minimum of 10 years. > Reports of genetic testing must be retained for at least 10 y

Federal law requires that labs retain the results of genetic testing for a minimum of 10 years. > Reports of genetic testing must be retained for at least 10 years. Electronic records are acceptable. Specific regulations for specimen retention are not proposed, but each laboratory must have a written policy defining its own specimen retention policy. http://clinchem.aaccjnls.org/content/45/5/739 http://clinchem.aaccjnls.org/content/45/5/739

astazangasta 7y ago
This is for CLIA tests, i.e. clinical tests. 23andMe is explicitly NOT this as they can't make medical claims. Just getting a piece of DNA sequenced does not require this kind of retention; GP is right, this is a viable business plan. Data retention is the next big wave and these companies would do well to clue in. There is zero chance they will find anything medically useful with their database and a ton of outstabding liability once people realize how it can be abused.
- eweitz 7y ago
  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. 1. https://medical.23andme.com/dna-kits/#clia https://medical.23andme.com/dna-kits/#clia 2. https://www.accessdata.fda.gov/cdrh_docs/pdf16/DEN160026.pdf https://www.accessdata.fda.gov/cdrh_docs/pdf16/DEN160026.pdf
  - astazangasta 7y ago
    Hmm, news to me. In any case the point still stands that you can do SNP sequencing without being CLIA certified.

astazangasta 7y ago

This is for CLIA tests, i.e. clinical tests. 23andMe is explicitly NOT this as they can't make medical claims. Just getting a piece of DNA sequenced does not require this kind of retention; GP is right, this is a viable business plan. Data retention is the next big wave and these companies would do well to clue in. There is zero chance they will find anything medically useful with their database and a ton of outstabding liability once people realize how it can be abused.

eweitz 7y ago
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. 1. https://medical.23andme.com/dna-kits/#clia https://medical.23andme.com/dna-kits/#clia 2. https://www.accessdata.fda.gov/cdrh_docs/pdf16/DEN160026.pdf https://www.accessdata.fda.gov/cdrh_docs/pdf16/DEN160026.pdf
- astazangasta 7y ago
  Hmm, news to me. In any case the point still stands that you can do SNP sequencing without being CLIA certified.