Real-World Data Presented At AHA Scientific Sessions Demonstrate Relationship Between Low-Density Lipoprotein Particle (LDL-P) Number And Future Risk Of Coronary Heart Disease

RALEIGH, N.C., Nov. 18, 2013 /PRNewswire/ -- 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 in cardiovascular, metabolic and other diseases, today announced that low-density lipoprotein particle (LDL-P) number can predict cardiovascular events independently of LDL cholesterol (LDL-C) concentrations in a real-world environment, as presented in a poster session at the 2013 Scientific Sessions of the American Heart Association.

In a poster entitled, "Relationship Between Risk for Coronary Heart Disease and Serum Levels of Low-Density Lipoprotein Particles," Peter P. Toth, MD, PhD, and colleagues presented data demonstrating that LDL-P correlates positively with future risk of coronary heart disease (CHD) in a sample of commercially insured patients. The study was sponsored by LipoScience and jointly designed by LipoScience and HealthCore, with clinical review from Dr. Toth and Terry A. Jacobson, MD, Professor of Medicine at Emory University, Atlanta.

"Although numerous epidemiological studies have demonstrated that LDL-P by NMR is a better predictor of cardiovascular events than LDL cholesterol concentrations, there was no real-world evidence of this association in the literature," said Dr. Toth, who is Director of Preventive Cardiology at CGH Medical Center in Sterling, Ill., and Professor of Clinical Family and Community Medicine at the University of Illinois School of Medicine in Peoria, Ill. "Our data demonstrate such a correlation in a real-world population of high-risk patients, and may help physicians devise risk-reduction strategies for their patients based on selection of appropriate LDL-P targets."

Dr. Toth and colleagues analyzed data from 15,569 high-risk patients selected from the HealthCore Integrated Research Database (HIRD^SM), a fully-integrated longitudinal claims research environment that combines medical, pharmacy and laboratory information drawn from nearly 43 million enrollees in Blue Cross and Blue Shield Plans and affiliated businesses across 14 states. Each of these patients had at least one LDL-P measurement determined using LipoScience's NMR LipoProfile® test, a laboratory test that utilizes NMR spectroscopy to measure lipoprotein particle concentrations. Among these patients, there was significant disagreement or discordance between LDL-C and LDL-P measures. More than 50% of high-risk patients had LDL-C levels at goal (<100 mg/dL) whereas only 15% had comparably low LDL-P levels (<1000 nmol/L). The risk of a future cardiovascular event was found to increase by approximately 4% for each 100 nmol/L increase in LDL-P, after adjusting for LDL-C levels. This increase in risk was particularly strong at LDL-P levels above the threshold of 1000 nmol/L. 

"The research shows us that we need to keep searching for better CVD risk management tools, such as LDL-P," said Mark Cziraky, PharmD, FAHA, Vice President of HealthCore. "Real-world evidence, drawn from a research environment with access to deep and broad clinical claims data can help us get there by advancing our efforts to ensure that healthcare decision-makers have the most meaningful information available."

Further analyses using the same database of commercially insured patients are investigating whether clinical management to LDL-P goals leads to better outcomes when compared to management to LDL-C goals alone. The ongoing study will compare reductions in risk of CHD/stroke events in high-risk patients achieving an LDL-P target <1000 nmol/L versus patients achieving an LDL-C target <100 mg/dL.

Other AHA Presentations Featuring Data Generated Using LipoScience's NMR Technology

Akintunde O. Akinkuolie, of the Division of Preventive Medicine at Brigham and Women's Hospital and Harvard Medical School in Boston, Mass., is the lead author of each of the following presentations at the AHA Scientific Sessions:

• Monday, November 18: "HDL Subclass Heterogeneity Relates to Differences in Risk of Incident Coronary Heart Disease," 5:00 to 7:00 pm, poster board number 9007, located in Hall F (session titled, "Best of Basic Science and Late-Breaking Science")
• Tuesday, November 19: "Novel Protein Glycan Derived Marker of Systemic Inflammation is Associated with Incident Cardiovascular Disease," 9:00 am to 5:00 pm, poster board number 7073, located in Poster Hall, Core 7 (session titled, "Inflammation and Adhesion Molecules 1")
• Wednesday, November 20: "Novel Protein Glycan Derived Biomarker is Associated with Incident Diabetes," 9:00 am to 12:00 pm, poster number 7098, located in Poster Hall, Core 7 (session titled, "Biomarkers in Cardiac Disease and Diabetes")

Elaine Urbina, MD, of the Cincinnati Children's Hospital will present the T. Duckett Jones Memorial Lecture, Best of Cardiovascular Disease in the Young (CVDY):

• Tuesday, November 19: "Lipoprotein Particle Number and Size Predict Vascular Structure and Function Better than Lipid Concentration in Young Subjects," 2:45 pm to 3:00 pm, in Ballroom A1.

About LipoScience, Inc.

LipoScience, Inc. is pioneering a new field of personalized diagnostics based on nuclear magnetic resonance (NMR) technology. The company's 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 10 million NMR LipoProfile tests have been ordered. LipoScience's automated clinical analyzer, Vantera®, has been cleared by the U.S. Food and Drug Administration (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 Clinical Analyzer will be placed with national and regional clinical laboratories.

LipoScience is striving toward the NMR LipoProfile® test becoming the preferred choice by physicians for the management of cardiovascular disease. For further information on LipoScience, please visit www.liposcience.com and www.theparticletest.com.

About HealthCore, Inc.

HealthCore, based in Wilmington, Del., is the clinical outcomes research subsidiary of WellPoint, Inc. HealthCore has a team of highly experienced researchers including physicians, biostatisticians, pharmacists, epidemiologists, health economists and other scientists who study the "real world" safety and effectiveness of drugs, medical devices and care management interventions. HealthCore offers insight on how to best use this data and communicates these findings to health care decision-makers to support evidence-based medicine, product development decisions, safety monitoring, coverage decisions, process improvement and overall cost-effective health care. For more information, go to www.healthcore.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 expectations for the future demand for its products and the factors that drive such demand. 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 Quarterly Report on Form 10-Q for the quarter ended September 30, 2013 and other filings the Company makes with the Securities and Exchange Commission from time to time.  These documents are available on the SEC Filings section of the Investor Relations page of the Company's website at http://investor.liposcience.com/. The statements made herein are based on information available to LipoScience as of the date of this press release, and the Company assumes no obligation and does not intend to update these forward-looking statements, except as required by law.

SOURCE LipoScience, Inc.