Transgenomic announced that the Clayton Foundation for Research of Houston, Texas through its technology transfer entity, the Research Development Foundation, has granted the company an exclusive license to patents covering a method for mitochondrial DNA (mtDNA) damage detection. The patents form the basis for the development of diagnostic tests in cardiovascular disease, diabetes, degenerative diseases of aging, cancer, and other diseases, by measuring increased oxidative damage within mitochondria.

Mitochondria are organelles that produce the energy required for cells to function normally. As the "power plants" of the cell, they are highly sensitive to oxidative damage, which reduces energy production. Epidemiologic and biologic studies suggest that oxidative stress is a risk factor for cardiovascular death, but the absence of an accepted measure has limited the ability to determine whether reducing oxidative stress will reduce cardiovascular risk. The licensed technology utilizes a quantitative polymerase chain reaction (PCR) measurement of mtDNA damage, and is a sensitive and specific indicator of oxidative stress.

The method was invented by researchers at the University of Texas in the laboratory of Dr Ben Van Houten. In collaboration with Dr Marschall Runge, they demonstrated that mtDNA damage in blood cells occurs early in atherosclerosis, that aortic mtDNA damage increases with age, and that genetic background and diet both can influence the level of damage. Preliminary studies suggest that the level of mtDNA damage also correlates with a near-term risk of major adverse cardiovascular events. Hence, measurement of mtDNA damage may be useful for predicting coronary atherosclerotic heart disease. Dr Van Houten, now at the Hillman Cancer Center at the University of Pittsburgh, has published more than 30 papers using this technology to follow damage and repair in mitochondrial and nuclear genomes. His laboratory has also shown that mtDNA damage develops in the brains of older mice and in a chemical model of Parkinson's disease. "We have demonstrated that reactive oxygen species cause significantly more mitochondrial DNA damage than nuclear damage in cells from human to yeast, and I am enthusiastic about moving this exciting assay from the bench to the bedside," he said.

Dr Runge, who is now chair of the Department of Medicine at the University of North Carolina at Chapel Hill School of Medicine, noted the value of a test for mtDNA damage developed for broad clinical application. He commented, "In collaboration with Transgenomic we will be able to pursue studies of large populations of individuals at risk of cardiovascular diseases, and determine the utility of this measure in patients who may benefit from therapies to reduce oxidative stress." Craig Tuttle, CEO of Transgenomic, commented, "We are pleased to conclude a license with the Clayton Foundation to develop this technology, which it has supported for many years. The license complements Transgenomic's mtDNA mutation analysis capabilities, and demonstrates continued strategic commitment to the rapidly growing area of mitochondrial analysis for pharmacogenomic research and clinical applications."

Transgenomic is a global biotechnology company that provides unique products and services of automated high sensitivity genetic variation and mutation analysis.

The Clayton Foundation for Research is a Houston, Texas-based non-profit medical research organization founded in 1933 by Benjamin Clayton. The Clayton Foundation and its supporting entities have more than thirty medical research projects at eleven institutions, and the Foundation has the rights to the intellectual property arising from these projects.

UNC Health Care System is a not-for-profit integrated health care system owned by the state of North Carolina and based in Chapel Hill. It exists to further the teaching mission of the University of North Carolina and to provide state-of-the-art patient care.