The institute has offered several white papers, including one on "Applying Genomics to Clinical Problems-Diagnostics, Preventative Medicine, Pharmacogenomics".
Some of the key questions are:
1. "What do new genetically-based diagnostic or risk assessment strategies add to the existing medical armamentarium?"
2. "What information will be needed or required by payers to convince them to reimburse genetically-based testing strategies, so that financial barriers to their application can be minimized?"
(You've got to answer question #1 before you start worrying too much about #2.)
3. "How will patients and clinicians respond to information regarding individualized genetic risk and what strategies and resources will be most effective in educating them to maximize health benefits and minimize potentially negative aspects such as stigmatization and anxiety?"
4. "What information will convince clinicians to apply genetically-based testing strategies to their patients, and what tools for decision support or patient management will encourage that choice?"
(Again, we'd better be sure of #3 before we start pushing #4.)
7. "What is the impact of receiving results of direct-to-consumer (DTC) genome-wide screening on patients' health behaviors, reproductive choices, quality of life, and long-term planning?"
DTC screening is here, and it's cheaper than an iPod Touch. Question #7 should be looked at, but, without knowing anything special about how people respond to genome-wide screening, we should start with the baseline of requiring the same standard of efficacy that's applied to all other diagonostic tests.