LipoScience, Inc.
Apr 25, 2013
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LipoScience Begins Clinical Development of NMR-Based Cardiovascular Diagnostic Test for Novel Gut Flora Metabolite

Research Findings Published in the April 25 Online Issue of the NEJM Demonstrate Intestinal Microflora TMAO as a Potential Cardiovascular Risk Target

RALEIGH, N.C.--(BUSINESS WIRE)-- LipoScience, Inc. (NASDAQ: LPDX), a diagnostic company pioneering a new field of personalized nuclear magnetic resonance (NMR) diagnostics to advance the quality of patient care, today announced the start of the clinical development phase of a diagnostic test for cardiovascular disease based upon research demonstrating that a unique gut flora metabolite, trimethylamine-N-oxide (TMAO), is a predictor of cardiovascular risk.

LipoScience entered into an exclusive licensing agreement with Cleveland Clinic in August 2011 to develop and commercialize a diagnostic test for cardiovascular disease based upon the gut flora metabolite TMAO. LipoScience plans to offer an NMR-based TMAO assay in the near term for research applications through their Global Research Services (GRS) division.

Clinical research findings from Cleveland Clinic published in the New England Journal of Medicine (NEJM), demonstrate that plasma levels of TMAO can predict future cardiovascular events. TMAO is generated in humans from dietary choline and phosphatidylcholine, which are abundant in foods such as meat, eggs, liver, and wheat germ. The study, Intestinal Microbial Metabolism of Phosphatidylcholine and Cardiovascular Risk, was led by Stanley L. Hazen M.D., Ph.D., Vice Chair of Translational Research for the Lerner Research Institute and section head of Preventive Cardiology & Rehabilitation in the Miller Family Heart and Vascular Institute at Cleveland Clinic.

"The role of intestinal microbes in complex metabolic disorders, such as obesity, has become widely recognized; however, the involvement of gut microbes in the development and progression of atherosclerosis has only recently been suggested. This presents opportunities to advance the diagnosis and treatment of cardiovascular disease risk," said Dr. Hazen, principal investigator. "To enable the expansion of research on TMAO and eventual market access, a widely available and efficient diagnostic assay for the metabolite is needed. We are working closely with LipoScience to develop an NMR-based assay to detect TMAO that will provide the research community, and eventually practicing clinicians, with this tool."

Cleveland Clinic has a licensing agreement with LipoScience to develop and commercialize a blood test for cardiovascular disease based upon the gut flora metabolite, TMAO. Dr. Hazen is listed as a co-investigator on pending and issued patents held by Cleveland Clinic relating to cardiovascular diagnostics. He also is a paid consultant to LipoScience and has received royalty payments for technology that he developed.

The study examined the relationship between the oral intake of phosphatidylcholine and the involvement of intestinal bacterial pathway of TMAO. In addition, the study confirmed the relationship between fasting plasma levels of TMAO and incident major cardiovascular events including death, myocardial infarction and stroke within an intermediate risk population of more than 4,000 adults.

"This study identifies TMAO levels, which are a by-product of our diet, as an independent contributor to cardiovascular events with potentially important clinical implications for advancing patient care," said Richard O. Brajer, Chief Executive Officer of LipoScience. "We are closely collaborating with Cleveland Clinic to develop a TMAO assay based on NMR technology to help accelerate this needed and important area of research, and we expect to offer a clinical version of the TMAO test to practicing physicians in the future."

About LipoScience, Inc.

LipoScience, Inc. is pioneering a new field of personalized diagnostics based on nuclear magnetic resonance (NMR) technology. Its first proprietary 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 9 million NMR LipoProfile tests have been ordered. LipoScience's automated Vantera® clinical analyzer has been cleared by the FDA. It requires no previous knowledge of NMR technology to operate and has been designed to dramatically simplify complex technology through ease of use and walk away automation. The Vantera system will be placed with national and regional clinical laboratories. LipoScience is driving toward becoming a clinical standard of care by decentralizing its technology and expanding its menu of personalized diagnostic tests to address a broad range of cardiovascular, metabolic and other diseases.¬†For further information on LipoScience, please visit www.liposcience.com and www.theparticletest.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements related to the Company's plans, objectives, expectations (financial and otherwise) or intentions. These forward-looking statements include statements about the Company's plans for potential future diagnostic tests. Actual results may differ significantly from those projected or suggested in any forward-looking statements.

Further information on potential factors and other risks that could affect the Company's business and operating results is included in the Company's Annual Report on Form 10-K for the year ended December 31, 2012 and other filings with the SEC.

Schwartz MSL
Stacey Holifield/Erin Zwirn, 781-684-0770
liposcience@schwartzmsl.com
or
LipoScience, Inc.
Tori Hall, 919-256-1046
tori.hall@liposcience.com

Source: LipoScience, Inc.

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