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| Opportunities & Exposures: Science |
A Cure of One’s Own
Steven Burrill
09/01/2005
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In the medical field, therapeutics has traditionally captured the headlines,
leaving the field of diagnostics (Dx) to languish in the shadow of drug
development. But now, thanks to the body of new information on the genetic,
genomic and proteomic profiles of different diseases, this situation is poised
to change dramatically. This new knowledge is driving the development of
molecular diagnostics, which can be defined as the use of diagnostic testing to
understand the molecular mechanisms of an individual patient’s
disease.
Molecular diagnostics, in fact, has the potential to completely
change the way health care is managed, allowing both the diagnosis of disease
and the administration of treatment to be performed at an earlier stage than is
currently possible. Today, drug dosage levels are based on a patient’s age, sex
and weight, as determined by empirical studies. However, the way your body
metabolizes a specific drug can be as individual as your fingerprints. Imagine
the significant improvement in treatment efficacy if the medications you take
were based on your own genetic analysis, not on the accumulated outcomes of
other patients. Suddenly, we are tantalizingly close to the promise of
personalized medicine.
With 80 percent of this country’s $1.7 trillion annual
health care spending allocated to the treatment of chronic diseases and an
estimated 125 million Americans living with one or more chronic conditions, the
economic incentive for disease prevention is enormous. Leading the brigade for a
more predictive, personalized and preventive approach to health care are the
payers: managed care companies and the government—two entities that, in one way
or another, foot most of the bill.
In fact, the FDA recently issued
guidelines for submitting pharmacogenomic data with new drug applications.
Indeed, the agency is encouraging the use of molecular diagnostics and
information-based medicine to more accurately couple the right therapy to the
right patient.
Ultimately, molecular diagnostics has the potential to
renovate the practice of medicine. It can be used to aid clinical diagnosis,
determine disease susceptibility, identify the correct tissue type in organ
transplantation and screen blood for transfusion. The technology and resultant
data will also facilitate drug discovery, molecular toxicology and the detection
of microbial contamination in biopharmaceutical manufacturing. It has niche
opportunities in forensic and veterinary medicine as well. In fact, the list is
limited only by the availability of a relevant gene sequence of interest and the
market demand for its identification.
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