LipoScience seeks FDA clearance for clinical analyzer, NMR test

LipoScience has submitted 510(k) application of its Vantera Clinical Analyzer and the NMR LipoProfile test to the US Food and Drug Administration (FDA).

Vantera Analyzer 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 facilitates physicians and their patients with actionable information in order to personalize management of risk for heart disease.

LipoScience CEO Richard Brajer said 510(k) submission is an important step toward their objective to decentralize their technology platform and extend the reach of the NMR LipoProfile test by providing laboratories across the US with the capability to perform the assay internally.