Paradigm Genetics and the University of North Carolina at Chapel Hill have joined a research project to find better means of diagnosing and assessing liver damage and how patients respond to treatment.

If successful, the project could identify liver problems with so-called biomarkers long before they normally are detected, often already after damage has occurred, according to Paradigm.

Also participating in the project are the National Institute of Environmental Health Science (NIEHS) and National Institutes of Health (NIH).

The project also could help other drug developments, according to a UNC researcher.

“Liver toxicity is one of the leading reasons that drugs fail in clinical trials or are withdrawn from market,” said Dr. Paul Watkins, a professor of medicine and pharmacotherapy at UNC and director of UNC Hospital’s general clinical research center. “Better markers of liver toxicity will help pharmaceutical companies make more informed decisions about the possible safety risks associated with new drugs entering clinical development.”

Paradigm said it would be responsible for biochemical profiling experiments on tissue and fluid samples from both humans and rats that have been exposed to acetaminophen, a common pain reliever. Based on its “Gene to Cell System” gene expression technology, Paradigm will incorporate NIEHS and UNC CH data to determine biomarkers that will act as more sensitive and more accurate indicators of the onset of liver disease, the company said.

“Today, liver damage is often undetected until serious complications
occur,” said Tom Colatsky, vice president of healthcare research at Paradigm, in a statement. “The current study will lay a foundation for identifying biochemical signals that are more sensitive than current standards and that bridge results obtained in the lab to clinical outcomes. If we can develop methods for earlier, more accurate prediction and detection of liver damage, we can save lives by increasing the window for successful medical treatment, while identifying the best treatment methods for each patient.”

Colatsky said the project could lead to discovery of “new, more powerful diagnostics” since Paradigm will be “tracking complex diseases from the gene to cell to system.” He said biomarkers could be detected in blood and urine samples that “are indicative of liver disease progression at the genetic level.”