Paradigm Genetics announced that data presented at last week's 23rd Annual Symposium of the Society of Toxicologic Pathology demonstrated that its automated pathology software could automatically distinguish between normal and diseased liver tissue and detect the presence and degree of hepatocellular hypertrophy.

These data were derived from studies performed in collaboration with the National Institutes of Environmental Health Sciences (NIEHS) and Experimental Pathology Laboratories (EPL) on rat liver tissues from subchronic toxicity studies previously conducted by the NIEHS and the National Toxicology Program (NTP). Data were also presented demonstrating that automated pathology software can enhance a pathologist's interpretation of tissue response by accurately and consistently identifying tissue features.

"These findings demonstrate that Paradigm Genetics' automated pathology software is readily able to detect tissue changes from normality as well as identify and provide quantitative histological biomarkers of drug-induced liver damage," said Peter Johnson, executive vice president, Life Sciences and CMO.

"The results of these collaborative studies highlight the value of machine vision in automated tissue analysis," said Tom Colatsky, vice president, Healthcare Research. "The ability to identify and quantitate subtle changes in tissue structure enables a better understanding of disease and drug action, and creates an opportunity to discover novel biomarkers and targets by integrating and rigorously analyzing multiple complex data streams," he added.

As the liver plays such a vital role in the body, it is frequently one of the most studied tissues for adverse effects in drug discovery and development. Hepatocellular hypertrophy is a morphologic change in which existing liver cells become enlarged and exhibit an increase in their functional capacity. This condition is considered largely an adaptive change that occurs in response to disease, chemical toxicity or drug therapies. As microsomal enzyme induction associated with hepatocellular hypertrophy can pose a potential risk in drug interactions, the presence and degree of hepatocellular hypertrophy is an important consideration in drug development.

At present, the presence and degree of hepatocellular hypertrophy is determined microscopically by pathologists and may be difficult to diagnose in some instances. Paradigm Genetics is actively marketing its automated pathology software to pharmaceutical companies to provide them with automated and objective mathematical quantification of tissue, including hepatocellular hypertrophy, and complete automated screening of tissue slide normality.