LipoScience Announces Exclusive License from Cleveland Clinic to Develop Cardiovascular Test Based on Gut Flora Metabolite

Research into link between gut flora and cardiovascular disease received prominent research award

RALEIGH, N.C.--(BUSINESS WIRE)-- LipoScience, Inc., an in vitro diagnostic company advancing patient care by developing high value proprietary clinical diagnostic tests using nuclear magnetic resonance (NMR) technology, announced that it has entered into an exclusive, worldwide licensing agreement with Cleveland Clinic to develop and commercialize a diagnostic test for cardiovascular disease risk based on a gut flora metabolite known as trimethylamine N-oxide (TMAO). The license agreement was entered into in August 2011.

A research team headed by Stanley Hazen, M.D., Ph.D., Professor of Molecular Medicine at Cleveland Clinic Lerner College of Medicine at Case Western Reserve University and Vice Chair of Translational Research at Cleveland Clinic’s Lerner Research Institute, discovered a link between gut flora – an individual's intestinal microbes – and cardiovascular disease risk. Their initial studies, published in an article in Nature in April 20111, demonstrated the impact of gut flora on the development of heart disease in both animal models and humans.

Based on this research, Dr. Hazen was honored recently as the winner of one of the Top 10 Clinical Research Achievement Awards in the United States for 2012. The new discovery may lead to new diagnostic tests and therapeutic approaches to the treatment of heart disease. The award is from The Clinical Research Forum, a nonprofit organization dedicated to providing national leadership in clinical research. Clinical Research Achievement Award winners represent major advances resulting from the nation’s investment in research to benefit the health and welfare of its citizens. These accomplishments will also be included in a report and presented to the U.S. Congress demonstrating the national clinical research return on investment.

“The discovery that gut flora can be a biomarker for cardiovascular disease could lead to incredible advances in testing,” Dr. Hazen said. “Using this discovery to help patients diagnose heart disease is very promising and can help improve clinical outcomes.”

“To date, all research on TMAO has been conducted using mass spectrometry for detection, which can be a tedious and time-consuming method. However, the properties of TMAO make it well-suited for measurement by magnetic resonance, making LipoScience the ideal collaborator to develop a clinically viable assay,” said Richard O. Brajer, Chief Executive Officer of LipoScience. “We look forward to working closely with the Cleveland Clinic team to make this new and important diagnostic assay available to our customers.”

About LipoScience, Inc.

LipoScience, Inc. is an in vitro diagnostic company committed to advancing patient care in cardiovascular, metabolic and other diseases using an innovative and proprietary technology platform based on nuclear magnetic resonance (NMR) technology. Our first diagnostic test, the NMR LipoProfile® test, measures the number of low density lipoprotein particles (LDL-P) in a blood sample and provides physicians and their patients with actionable information to personalize management of risk for heart disease. To date, over 7 million NMR LipoProfile tests have been ordered. For further information on the Company, please visit www.liposcience.com and www.theparticletest.com.

1 Wang, Zeneng, et al. (2011). "Gut flora metabolism of phosphatidylcholine promotes cardiovascular disease". Nature 472, 57-65.



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