> 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.
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.
"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
Sell it for use in embryo selection, employee profiling, to governments.
The scientific community has already created all the tough parts of the software stack, and everything has been commoditized already, there's just not much of a customer base.
The customers that it's really really useful for are those with rare phenotypes that want to learn more, and they can't find a doctor with expertise, and there's no lab specialized in genetic testing for that.
However, those are also the cases where the off the shelf software/sequencing doesn't always give the right answer because it's not a simple small change, and then you need specialists both on the biology and bioinformatics side to really make it useful.
Here's a service. Pay to get your panel/exome/whole genome sequenced, put your data on gcp/aws/azure, user open source to do variant analysis and pay a specialist for their computer aided analysis.
Guess what, you own your data end to end. I imagine the above could be had for less than $2k. Some startup will write the software stack to do this and simply sell licenses for software you run anywhere you want.