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 CHI Advances MONITOR series. The
CHI 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.