First NMR Clinical Lipoprotein Analyzer Receives FDA Clearance

LipoScience, Inc., has received 510(k) clearance from the U.S. Food and Drug Administration to market the Vantera^® Clinical Analyzer.

The Vantera Clinical Analyzer combines nuclear magnetic resonance (NMR) spectroscopic detection and proprietary signal processing algorithms to identify and quantify concentrations of lipoproteins and, potentially, small molecule metabolites. It requires no previous knowledge of NMR technology to operate and has been designed to dramatically simplify complex technology. Ease-of-use and walk-away automation provide efficient workflow to maximize laboratory resources while producing high quality results.

“LipoScience is pioneering a new field of personalized diagnostics based on NMR technology,” said Rick Brajer, Chief Executive Officer of LipoScience. “The FDA clearance of our Vantera Clinical Analyzer is a pivotal event that advances our vision of decentralizing our technology and becoming a clinical standard of care.”

The first assay cleared on this new in vitro diagnostic platform is low density lipoprotein particle number (LDL-P). LDL-P is a key component of LipoScience’s NMR LipoProfile® test, which provides physicians and their patients with actionable information to personalize management of risk for heart disease from a single blood sample. To date, over 8 million NMR LipoProfile tests have been ordered to aid in the management of patients’ heart health.

“Historically, all NMR LipoProfile tests have been performed at LipoScience’s CLIA-certified laboratory in North Carolina,” said Tom Clement, Vice President of Regulatory and Quality Affairs. “The 510(k) clearance of the Vantera Clinical Analyzer will allow us to place Vantera systems in select high-volume national and regional clinical diagnostic laboratories across the U.S., as well as at leading medical centers and hospital outreach laboratories, in order to drive both geographic expansion and the technology adoption necessary for successful execution of our market conversion strategy.”