Perhaps any one of several trained medical professionals on HN could chime in here to explain (a) how suitable 23AM's current product is for clinical use and (b) how competent a typical physician is at evaluating clinical genomics products without FDA's assistance. 'carbocation? 'niels_olson?

('carbocation has already expressed some tacit support for FDA's action, but I'm not qualified to interpret it in the context of this particular subthread).

> The 23andme product explains explicitly how it should be used by a physician

Generally, for diagnostic tools, drugs, etc., it is not enough that the product labelling explains how it should be used, but it is required to demonstrate to the FDA that there is evidence that it works as marketed when used according to those directions. The FDA Warning Letter specifically calls out 23andMe's failure to either identify existing approved products on the market to which the product is equivalent (which wouldn't reduce the requirements for proving this) or to meet the requirements for demonstrating the effectiveness of their offering as a new product without existing, approved equivalents.

How do you think 23andme should answer that question?

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

> 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.

  Any doctor educated in the past two decades
  is well versed in genetic testing

I'm not sure what definition of "well versed in genetic testing" you had in mind but this is untrue for most or all reasonable definitions.

  any doctor specializing in areas where genetic testing
  is a frequently used aspect of planning/diagnosis
  (such as OB/GYN) will be highly familiar even if trained long ago.

Also an overstatement. The trouble is that "genetic testing" is a large and complex field. Are you referring to a single-gene test for a well-known and well-characterized disease? Or whole exome sequencing? Because in the coming years doctors will come into contact with both. In general these tests will require specialist interpretation; not general physicians or OB/GYNs.