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LipoScience seeks regulatory approval for test

January 6, 2012
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LipoScience, which had 171 employees as of June 30, announced today that it is seeking permission to market the device from the Food and Drug Administration. The company previously reported in a securities filing that it hopes to win regulatory approval in time to begin selling the device later this year.

CEO Richard O. Brajer said in a prepared statement that decentralizing administration of the test would have several benefits, including significantly reducing the turnaround time for test results in some cases.

Company officials couldn’t immediately be reached for additional comment.

LipoScience’s ultimate goal is to replace traditional cholesterol tests. In 10 clinical trials involving more than 48,000 patients, the LipoProfile test has proven to be a better indicator of heart disease than traditional tests, according to the company. The LipoProfile test measures the quantity and size of lipoprotein particles, which carry cholesterol, in the blood.

Selling the Vantera device to other labs could conceivably raise the profile of LipoScience’s test. “There is not currently widespread awareness of the NMR LipoProfile test among clinicians, even though the test has been available since 1999,” the company declared in a securities filing.

In June the privately held company disclosed in a filing with the Securities and Exchange Commission that it hopes to raise $86.25 million in an initial public offering of stock. The company first filed IPO plans in 2002, but subsequently scrapped them.

At the end of September the company filed updated financial documents with the SEC, a sign that it remains interested in pushing ahead with its latest IPO plan.

LipoScience reported that over the fist six months of the year it generated $21.7 million in revenue, up 12 percent from a year earlier. The company lost $809,000 during that span, down from a $1.1 million profit, as it boosted research-and-development expenses by 15 percent and expanded its sales and marketing staff from 50 to 69.

Article source: http://newsobserver.com/2012/01/05/1755533/liposcience-seeks-regulatory-approval.html

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