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coordination of CER conducted or supported by Federal departments and agencies.
Furthermore, the legislation indicated that “the Council shall submit to the President
and the Congress a report containing information describing Federal activities on
CER and recommendations for such research conducted or supported from funds
made available for allotment by the Secretary HHS for CER. The Institute of
Medicine considers the following as priority areas for CER studies:
- Comparison of the effectiveness of patient decision support tools on informing
diagnostic and treatment decisions. - Comparison of adding information about new biomarkers (including genetic
information) with standard care in motivating behavior change and improving
clinical outcomes. - Diagnostic imaging performed by non-radiologists versus radiologists
- Alternative clinical management strategies for hepatitis C, including alternative
duration of therapy for patients based on viral genomic profi le and patient risk
factors.
Role of the US Government Agencies in Personalized Medicine
Various US Government agencies involved in personalized medicine are: FDA (see
under regulatory agencies), NIH, CDC, National Institute of General Medical
Sciences, National Institute of Standards and Technology, Centers for Medicare and
Medicaid Services, and AHRQ (see preceding section). The work of these agencies
is not coordinated.
Evaluation of Genetic Tests and Genomic Applications
The Evaluation of Genomic Applications in Practice and Prevention (EGAPP)
group’s recommendations are part of a pilot project by the National Offi ce of Public
Health Genomics at the US Centers for Disease Control and Prevention. The project
aims to evaluate genetic tests and other genomic applications currently in transition
from research to clinical use. EGAPP released three new sets of recommendations
about gene expression profi ling in breast cancer, genetic testing for Lynch syndrome
in colorectal cancer patients, and testing for UGT1A1 in colorectal cancer patients
treated with irinotecan. These evaluations are in currently in draft form. Of the three
recommendations, the one investigating gene expression profi ling in breast cancer is
the furthest along. There is limited evidence of analytic validity, limited evidence of
clinical validity but no direct evidence, i.e. controlled trials testing clinical outcomes
or clinical utility. There are mixed estimates of cost-effectiveness. In spite of these
concerns, there is a positive balance with potential benefi ts versus potential harms.
Earlier EGAPP reports evaluated cytochrome P450 testing with AmpliChip
(Roche) or other tests to guide physicians treating patients with depression who are
taking SSRIs (EGAPP Recommendation Statement 2007). There was insuffi cient
evidence to support a recommendation for or against use of CYP450 testing in
20 Development of Personalized Medicine