Abstract
The Impact of Genomics on Clinical Trials and Medical Practice evaluates the
potential of clinical genomics to transform drug development and the practice
of medicine. The report projects significant growth opportunities in this
field, balanced with a realistic assessment of the challenges and hurdles to
bringing clinical genomics to mainstream medicine.
Clinical genomics is the application of large-scale, high-throughput genomics
technologies in clinical settings, such as clinical trials or primary care of
patients. Clinical genomics promises to allow a molecular understanding of
disease and drug response, with benefits in all areas of medicine.
Contributing to the growth of genomics, in 2005 the FDA issued guidelines for
applications of genomics in drug development, with the stated hope that
genomics will improve the safety and effectiveness of medicines. Given this
mandate, clinical genomics applications appear to have crossed a threshold
with the recent approval of several clinical genomics products. These
approvals are expected to provide important precedents for other product
approvals in the near future.
Examples reviewed in the report include the following:
- Roche Diagnostics' AmpliChip Cytochrome P450 Genotyping Test: In 2004 this
test, a DNA chip that identifies variations in two genes affecting response to
a wide variety of drugs, became the first microarray approved for treatment
decisions by the FDA.
Third Wave Technologies' Invader UGT1A1 Test: This test for detecting
heightened risk of adverse reaction to the chemotherapy drug irinotecan was
FDA-approved in 2005 as the first pharmacogenetic companion diagnostic paired
with a specific drug therapy. Genomics applications in clinical trials are
also dramatically rising. It is now estimated that about 20% of U.S. clinical
trials use some sort of genomics approach, with the highest percentage in
oncology trials. While this trend is expected to accelerate during the next
few years, the field still faces considerable regulatory, technical, economic,
and sociological hurdles. The full promise of clinical genomics applications
may not be fully realized for at least another ten to fifteen years. However,
as genomics transitions away from primarily research to more clinical
applications, the field will be ripe with business opportunities and the
report examines some of the business and strategic factors relevant to the
further adoption of genomics technologies in clinical trials and medical
practice.
This report is part of the CHA Advances MONITOR series. The CHA Advances
MONITOR series singles out markets, technologies, and industry sectors that
are characterized by propulsive growth and by the potential to change the
basis of competition in the pharmaceutical industry. We plan to visit these
subjects approximately every 2 years.
About the Author
Gwen Acton, Ph.D., is president of Vivo Group, a consulting firm specializing
in evaluation and management of genomics and life science technology. Prior to
this, Dr. Acton served as Director of Scientific Development at the Whitehead
Institute for Biomedical Research, and ran the operations of the Functional
Genomics Program at the Whitehead Institute/M.I.T. Center for Genome Research.
Dr. Acton received a doctorate in molecular biology and genetics from M.I.T.
and served as a faculty member at Harvard University in the Department of
Molecular and Cellular Biology.
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