603diagnosis and treatment of cancer and other diseases. Such collaboration will
combine the strengths of genomics, functional genomics and molecular imaging to
place better information in the hands of healthcare professionals to enable them to
genetically determine a patient’s risk for developing disease long before any symp-
toms appear without unnecessary exploratory procedures. The University of Texas
M. D. Anderson Cancer Center (Houston, Texas) conducts multi-disciplinary
research using these combined technologies.
Role of the US Government and Agencies in Personalized
Medicine
US healthcare system is facing a crisis because of high cost and lack of health insur-
ance for a signifi cant percentage of population. Improvement of healthcare is a pri-
ority for the US government. Implementation of personalized healthcare will
depend on the fi nal plan that will be implemented. Meanwhile research and devel-
opment relevant to personalized medicine continues in the US.
A bill was introduced in US Congress in 2006 by Senator Obama, who later
became President of the US, titled “Genomics and Personalized Medicine Act of
2006” that aimed to advance personalized medicine and pharmacogenomics. It was
replaced later by another bill that included a new tax incentive for personalized
medicine research. The Genomics and Personalized Medicine Act of 2008
(H.R.6498) adds tax and test credit incentives to lure researchers into the fi eld. The
bill was introduced and referred to the House Ways and Means Committee and to
the House Energy and Commerce Committee. The core focus of the act is on the
following points:
- It would create a Genomics and Personalized Medicine Interagency Working
Group that would include the NIH, the FDA, the Centers for Disease Control and
Prevention, and other groups outside of the Department of Health and Human
Services. - It also would start a National Biobanking Initiative that would create a database
for collecting and integrating genomics data with environmental and clinical
health information. It also would use funding to improve training for diagnosis
of genetic diseases and disorders, and for treatment and counseling. - The fi nal part of the bill would implement an oversight matrix for regulating
genetic tests and pharmacogenomic tests, and would encourage the development
of companion diagnostics by drug sponsors and by device companies. - An amendment will include tax credit for research expenses incurred in the
development of a companion diagnostic test.
The description of the act focuses on genomics and genetic testing and misses the
broad contest of personalized medicine as discussed in this report. Although it is an
encouraging step, it remains to be seen if it will facilitate the introduction of person-
alized medicine and add to the advances already made in the industrial sector.
Role of the US Government and Agencies in Personalized Medicine