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Heart disease diagnostic system from LipoScience seeks FDA 510(k) clearance

January 7, 2012

Diagnostics firm LipoScience is seeking U.S. Food and Drug Administration clearance for a new lab-based technology platform that tests for heart disease risks.

LipoScience has commercialized a blood test that measures the density of lipoproteins in a sample, a measure that the company says is a better gauge for cardiovascular disease than cholesterol tests. So far, LipoScience has conducted more than 6.5 million lipoprotein tests analyzed by nuclear magnetic resonance, or NMR, technology originally developed at North Carolina State University. But those test samples must be sent to LipoScience’s Raleigh, North Carolina headquarters for processing — the only place with the capability to conduct the analysis.

LipoScience’s 510(k) submission to the FDA aims to broaden the NMR test’s reach. If the FDA grants regulatory clearance for a new analyzer that LipoScience calls Vantera, laboratories in hospitals and research facilities across the country could get their own analyzers to conduct the NMR tests at their own sites.

“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,” LipoScience CEO Richard Brajer said in a statement. “In some cases, it could also significantly reduce turnaround time for test results.”

LipoScience is in the midst of plans to go public. The venture capital-backed company last summer filed with securities regulators plans for an initial public offering of stock that could raise up to $86.2 million. No effective date was set for the registration statement, which has since been updated three times. According to the most recent filing, the NMR tests generated $21.7 million in revenue in the first half of 2011, a 12.4 percent increase compared to the first six months of 2010. According to the company’s filings, a small number of diagnostic laboratory customers account for most of the NMR LipoProfile test revenue. LipoScience sees Vantera as crucial for revenue growth.

“A key element of our strategy is to place the Vantera system, our next-generation automated clinical NMR analyzer, on site with selected clinical diagnostic laboratory customers to broaden access to our technology and increase demand for our NMR LipoProfile test and any future diagnostic tests that we may develop,” the company said in a filing.

Vantera has already been pilot tested at several facilities across the country including the Mayo Clinic and the Cleveland Clinic. If cleared by the FDA, LipoScience plans to make Vantera commercially available later this year.

Article source: http://www.medcitynews.com/2012/01/heart-disease-diagnostic-device-from-liposcience-seeks-fda-510k-clearance/?utm_source=rss&utm_medium=rss&utm_campaign=heart-disease-diagnostic-device-from-liposcience-seeks-fda-510k-clearance


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