Great Smokies Diagnostic Laboratory Announces Launch of Comprehensive Digestive Stool Analysis 2.0.

Business Editors/Health/Medical Writers

ASHEVILLE, N.C.--(BUSINESS WIRE)--March 31, 2003

Recent Scientific Advances Yield New Gold Standard for Noninvasive

Analysis of Gastrointestinal Function

Great Smokies Diagnostic Laboratory (GSDL) today announced the launch of the latest version of its leading diagnostic assessment, the Comprehensive Digestive Stool Analysis (CDSA).

The enhanced assessment, developed by gaining exclusive rights to recent proprietary advances in gastroenterology and biotechnology research, offers physicians unparalleled insight into the diagnosis and treatment of patients with digestive conditions, such as Irritable Bowel Syndrome and Inflammatory Bowel Disease. The novel panel also evaluates risk factors for serious gastrointestinal diseases such as colorectal cancer.

"This advanced test represents the gold standard in noninvasive digestive analysis," says Frank Taylor, GSDL Chairman, CEO, and President. "The CDSA 2.0 will allow physicians to diagnose, assess, and monitor a wider range of gastrointestinal conditions-- with greater clinical precision--than ever before."

In addition to providing a comprehensive evaluation of gut microbial ecology and digestive function, the new CDSA 2.0 offers expanded diagnostic capability for physicians to:

-- Distinguish definitively between chronic functional digestive

disorders like Irritable Bowel Syndrome and organic diseases

such as Inflammatory Bowel Disease.

-- Utilize the most sensitive markers for noninvasive risk

assessment of colorectal cancer, the second leading cause of

cancer death in the U.S.

-- Evaluate pancreatic digestive enzyme output without

interference from digestive supplements, changes in stool

transit time, or marker variability.

-- Improve speed and accuracy in monitoring eradication therapy

for H. pylori, the causal bacterium in peptic ulcer disease.

The 2.0 version also significantly expands a clinician's ability to identify pathogenic yeast and parasites in the gastrointestinal tract through a proprietary Optimized Parasite Recovery technology. In addition, the analysis detects both C. difficile toxins A and B, the number one cause of antibiotic-associated diarrhea.

Recognizing the central role of the digestive tract in health and disease, GSDL introduced the original CDSA in 1987. The assessment quickly set the industry standard for noninvasive digestive analysis. Over the last two decades, it has become an essential diagnostic tool for thousands of physicians worldwide.

The CDSA 2.0 builds upon the successful foundation of the original assessment by adding cutting-edge markers such as calprotectin, a sensitive indicator of inflammation in the bowel.

"Markedly increased levels of calprotectin may be a strong indication of neoplastic (tumor-forming) processes in the gastrointestinal tract--even in the presence of negative results from other diagnostic evaluations, such as colonoscopy," observes Magne K. Fagerhol, Ph.D., of the Department of Immunology and Transfusion Medicine at Ullevaal University in Oslo, Norway. "This enhanced detection ability could save patient lives."

Another novel marker, pancreatic elastase-1, provides an extremely reliable indicator of exocrine pancreatic function--critical in the evaluation of patients with unexplained maldigestion or abdominal pain. Pancreatic exocrine dysfunction has been observed in up to 30% of type I and type II diabetics.

"Currently pancreatic elastase-1 appears to be the best noninvasive assessment of pancreatic function available," says Phillip P Toskes, M.D., Professor of Medicine in the Division of Gastroenterology, Hepatology, and Nutrition at the University of Florida College of Medicine at Gainesville. "Its sensitivity and specificity outperform other noninvasive pancreatic tests that have been evaluated."

There is enormous clinical need for a more advanced noninvasive diagnostic tool to improve prevention and treatment strategies for gastrointestinal disorders.

Digestive complaints are among the most common reasons that individuals seek medical care. According to the National Digestive Disease Information Clearing House, there are 22 million reported cases of acute digestive conditions, including indigestion, abdominal pain, and bowel dysfunction, in the U.S. each year. Digestive diseases kill nearly 200,000 Americans annually, and account for healthcare expenditures totaling over $100 billion.

The CDSA 2.0 will help physicians develop earlier, more effective preventive interventions, improve the timing and precision of treatments, and reduce the risk of clinical relapse in certain groups of patients. It will also allow physicians to better evaluate and document the medical necessity for more invasive procedures, such as colonoscopy.

Great Smokies Diagnostic Laboratory (GSDL) is a premiere provider of specialized laboratory assessments, both phenotypic and genotypic, that enable primary care practitioners to better identify and treat root causes of disease.

GSDL provides diagnostic leadership to advance the emerging clinical emphasis on prevention and early detection. Its innovative diagnostic tools are specially developed to provide focused and comprehensive insight into key areas of applied biochemistry and physiology, especially in the areas of women's health, cardiovascular disease, and gastrointestinal function.