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| Opportunities & Exposures: Science |
A Cure of One’s Own
Steven Burrill
09/01/2005
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Although at present molecular
diagnostics represents only a small portion of the global clinical in vitro
diagnostics marketplace, current estimates value the worldwide market at about
$1.5 billion. Going forward, the market is set to increase at an annual growth
rate of approximately 15 percent. At this time, more than 300 companies market
molecular diagnostic products. While three companies—Roche, Bayer and Abbott
Diagnostics—control a majority of the market, many small biotech companies also
contribute to the new technology base.
Last year saw several significant
advances, such as the development of the first genetic lab test system that
enables physicians to prescribe medications based on a patient’s DNA. Also, the
FDA approved about 20 novel tests, including one that can determine which
patients will respond favorably to a transplant and which will not.
We are
also seeing the emergence of theranostics, which combines drug therapy and
diagnostics to advance two goals of personalized medicine: to identify those
patients most likely to respond to a given medicine and to monitor the
biological effects of the drug as therapy progresses.
Despite its benefits,
molecular diagnostics must clear several roadblocks to widespread adoption.
Reimbursement by third-party payers is a primary concern, as is the lack of
standardization across test platforms and the inability of physicians to fully
interpret pharmacogenomic data.
Because molecular diagnostics reveals an
individual’s genetic data and isolates risk for specific diseases, ethical
questions come into play. These issues merit debate, a process that is already
underway as innovators and regulators proactively support sound public policy
that will accelerate the adoption of personalized medicine. The move to a more
personalized, predictable and preventive health care world is upon us. | Steven Burrill is CEO of Burrill & Co., a biotechnology venture
group, and an adjunct professor at the University of California, San
Francisco. |
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