LipoScience Submits FDA 510(K) for Vantera® Clinical Analyzer

If cleared, Vantera would allow clinical laboratories to bring the NMR LipoProfile^® test in-house, enabling geographic expansion and technology adoption necessary for successful market conversion

RALEIGH, N.C.--(BUSINESS WIRE)--LipoScience, Inc., an in vitro diagnostic company advancing patient care by developing high value proprietary clinical tests using nuclear magnetic resonance (NMR) technology, today announced that it has submitted the Vantera^® Clinical Analyzer and the NMR LipoProfile^® test to the U.S. Food and Drug Administration (FDA) for 510(k) clearance. If cleared, Vantera would become the first clinical diagnostic platform based on nuclear magnetic resonance commercially available for in vitro diagnostic use.

“Today’s 510(k) submission is an important step toward our objective to decentralize our technology platform and extend the reach of the NMR LipoProfile test by providing laboratories across the U.S. with the capability to perform the assay internally”

Vantera combines proprietary signal processing algorithms and NMR spectroscopic detection to identify and quantify concentrations of lipoproteins and, potentially, small molecule metabolites. The NMR LipoProfile test measures the concentration 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 6.5 million NMR LipoProfile tests have been ordered to aid in the management of patients’ heart heath. Today, the NMR LipoProfile test is performed only in LipoScience’s CLIA-certified laboratory.

“Today’s 510(k) submission is an important step toward our objective to decentralize our technology platform and extend the reach of the NMR LipoProfile test by providing laboratories across the U.S. with the capability to perform the assay internally,” said Richard O. Brajer, chief executive officer of LipoScience. “In-house testing will allow labs to optimize their accessioning and logistics, to leverage their internal quality systems, and to facilitate integration into peer proficiency testing. In some cases, it could also significantly reduce turnaround time for test results.”

The NMR LipoProfile test has been studied in ten coronary disease outcome trials involving over 48,000 patients. In each of the studies, LDL particle number (LDL-P) was more strongly linked to the disease outcome than was LDL cholesterol level. Recently, in October 2011, a panel of experts in the field of clinical lipidology, convened by the National Lipid Association, recommended testing for several cardiovascular biomarkers, including LDL-P, for the clinical assessment and on-treatment management of cardiovascular disease (CVD) risk in intermediate and high risk populations.

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 6.5 million NMR LipoProfile tests have been ordered by clinicians. For further information on the Company, please visit www.liposcience.com and www.theparticletest.com.