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
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)
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
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
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.
Stacey Holifield/Erin Zwirn, 781-684-0770
Tori Hall, 919-256-1046
Source: LipoScience, Inc.
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