NMR analyser is first designed for the clinical lab

THE FIRST fully-automated nuclear magnetic resonance (NMR) diagnostic analyser created specifically for the clinical laboratory has granted approval by the US Food and Drug Administration (FDA).

The Vantera clinical analyser from LipoScience combines proprietary signal-processing algorithms and NMR spectroscopic detection to identify and quantify concentrations of lipoproteins and, potentially, small-molecule metabolites.

Critical NMR components for the analyser are supplied by Agilent Technologies.

The Vantera analyser was granted 510(k) clearance from the US FDA on 5 September 2102, allowing it to be marketed to laboratories in the USA.

The device is said to require no previous knowledge of NMR technology to operate, being designed to simplify the technology. Ease-of-use and walk-away automation provide efficient workflow to maximise laboratory resources while producing high quality results, says Liposcience.

The first assay cleared on this new in vitro diagnostic platform is low density lipoprotein particle number (LDL-P), a key component of LipoScience’s NMR LipoProfile test.

To date, over eight million LipoProfile tests have been performed, all of them at LipoScience’s CLIA-certified laboratory in North Carolina. The new FDA approval means that the bigger national and regional clinical diagnostic laboratories in the USA, plus leading medical centres and hospital outreach laboratories, can install Vantera analysers to complete their own tests.

“LipoScience is pioneering a new field of personalised diagnostics based on NMR technology” said Richard O Brajer, the company’s chief executive officer.

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