Conclusion

It is clear that this is an area ripe with possibility. It is also clear that lack of leadership and communication in and among federal agencies and other stakeholders, a lag in the time regulation takes to catch up to innovation, and competition across all stakeholder groups has left much fruit on the vine, but with the potential for demise rather than success.

We opened this space to invite truth and honest interactions. We achieved that goal, the result of which is the prior list of recommendations. Following this meeting, a number of companies, academic groups, and advocacy organizations came together to work out concrete recommendations for alternative models. Federal agencies invited input from these and other groups. The community has taken action on each recommendation, some more than others.

The most difficult aspect of releasing the great potential of genetics and genomics as it moves into medicine is not the science, nor the intellectual endeavors. The most difficult task is encouraging honest interactions that will result in the best solutions. Society needs appropriate regulation