The Genomics Law Report Blog offered a spectacular summary of 5 recent letters sent to the big-name DTC genetic testing companies marketing and selling in the US.  While much of the criticism focussed on these tests being marketed without FDA approval, the solution itself seems fairly simple – involve physicians.

Perhaps the most palatable option for many of these companies is to consider altering the product in a manner that would convince the FDA it no longer qualifies as a device requiring premarket approval or clearance, for instance by removing the ability of consumers to purchase the product without the participation of a healthcare provider.

All tests can provide value if the results are delivered in the right context.  It will be interesting to see how these companies respond to this new FDA threat.