ASHEVILLE, N.C.--(BUSINESS WIRE)--Sept. 9, 2002--Great Smokies Diagnostic Laboratory (GSDL) today announced the expansion of its successful Genovations(TM) line of predictive genomic tests with the launch of the DetoxiGenomic(TM) profile, an assessment of over 20 genetic variants affecting the body's ability to metabolize drugs, hormones, and environmental toxins.

The new DetoxiGenomic(TM) profile is the latest addition to the Genovations(TM) line, which applies recent breakthroughs in genetic research to create powerful and innovative clinical assessment tools for primary care physicians to practice personalized medicine.

Genovations(TM) tests measure individual genetic variations called single nucleotide polymorphisms. Under the influence of environmental triggers, these variations can make even a healthy person more prone to develop certain diseases or physiological imbalances. This allows physicians to implement customized preventive interventions earlier and with greater specificity than ever before, to reduce a patient's disease risk before symptoms appear.

"With Genovations(TM), we became the first clinical laboratory to provide predictive genomic tests to the primary care physician," says Frank Taylor, GSDL Chairman, CEO, and President. "The DetoxiGenomic(TM) profile represents the latest achievement in our ongoing mission to translate advances in genomic research into useful diagnostic products for the primary care market, solidifying our position on the forefront of predictive diagnostic genomics."

The DetoxiGenomic(TM) profile evaluates genetic variations that influence Phase I and Phase II detoxification, the biochemical process the body uses to metabolize and eliminate toxic chemicals. This will allow primary care physicians to identify patients who may be more susceptible to adverse reactions to certain drugs or medications, or to illnesses caused by repeated exposure to environmental toxins.

"The detoxification system is the body's primary defense against 'foreign' chemicals entering the body," explains Patrick Hanaway, M.D., GSDL Medical Director. "This new profile will allow doctors to identify potential genetic 'trouble spots' in this self-defense system early on, so they can design precise, individualized therapy to support detoxification and to avert health problems - as well as adverse reactions to supplements and medications - before they happen."

The potential clinical benefits are enormous. Adverse reactions to prescription drugs have been ranked as the fourth to the sixth leading cause of mortality in the U.S. Each year about 100,000 Americans die from adverse reactions to pharmaceuticals - more than double the number killed in motor vehicle accidents. Annual hospital costs from these reactions have been estimated at between $1.5 to $4 billion.

"One gene evaluated in this new profile affects an enzyme the body uses to detoxify over 50% of all drugs - including many anti-depressants, steroid hormones, and lipid-lowering medications," Dr. Hanaway points out. "Another affects an enzyme that metabolizes over 38% of drugs commonly cited in adverse drug reaction studies."

Besides being exposed to a growing variety of drugs, the human body is exposed to increasing toxic compounds in the environment, including pesticides, polycyclic aromatic hydrocarbons (e.g. car exhaust, tobacco smoke), and solvents. Environmental factors are now generally believed to be involved in the causation of nearly all cancers; the World Health Organization has estimated that environmental factors constitute 25-33% of global disease burden.

While other genetic assessments typically analyze isolated detoxification pathways involved in the processing of pharmaceuticals, the DetoxiGenomic(TM) profile goes beyond that, by assessing over 20 genetic variations affecting the patient's ability to detoxify food components, steroid hormones, medications, and environmental toxins.

This will allow primary care physicians to intervene earlier, to help patients reduce the risk of developing diseases linked with chronic exposure to toxic substances, including multiple chemical sensitivity, neurodegenerative disorders, and chronic fatigue syndromes.

The DetoxiGenomic(TM) profile joins the growing list of Genovations(TM) profiles, which include targeted predictive genomic diagnostic profiles for cardiovascular health, bone health, and immune function. With this profile, Great Smokies Diagnostic Laboratory strengthens its position as the leader in predictive genomic testing and physician education, bringing patients closer to the full promise of personalized medicine.

Additional predictive genomic profiles for the primary care market will be available soon.

Great Smokies Diagnostic Laboratory provides advanced, innovative assessments of gastrointestinal, endocrine, immune, nutritional, and metabolic function to healthcare providers worldwide. GSDL's quality clinical laboratory services are licensed by Medicare and several state regulatory agencies, and accredited by the College of American Pathologists.