Re:FDA Warning Letter to 23andMe
by dragonwriter on Monday November 25, 2013 @02:45PM
(#6796418)
> How do you think 23andme should answer that question?
I don't know enough about 23andMe's operations and those of what appear from the outside to be generally similar services to answer that. Assuming that they really are an innovative service, they would need to conduct and provide the studies supporting the validity of their innovative service.
There are at least three different products in the space and to claim similarity would be to likely invite over-regulation:
- "full scan" companies, that do a full genetic scan and do not limit the scan to SNPs
- personal genomics companies that focus on SNPs
- medial diagnostics like the MSAFP test