Diagnostics company LipoScience (NASDAQ:LPDX) has voluntarily withdrawn its application for regulatory clearance on its latest coronary heart disease diagnostic.
LipoScience will work on a new submission to the Food and Drug Administration that includes additional clinical data, the Raleigh company said in a regulatory filing.
“At the present time, the Company cannot provide a timeline for resubmission but intends to do after further discussions with the FDA,” LipoScience said in the filing.
LipoScience has already commercialized a blood test for cardiovascular disease. LipoProfile tests a blood sample to measure the density of lipoproteins, which the company has positioned to clinicians and payers as a better gauge of cardiovascular disease risks compared to cholesterol tests, the current standard.
HDL-P was to become LipoScience’s next cardiovascular disease diagnostic, testing for high-density lipoproteins. But the withdrawal of the 510(k) submission marks the second time that LipoScience has pulled back on getting regulatory clearance for this test.
LipoScience filed for clearance in 2011 but voluntarily withdrew that application in March 2012 after the FDA raised concerns about two clinical studies. In one of those studies, the FDA was concerned that the study subjects were first evaluated in the early 1990s, LipoScience said in regulatory filings. The FDA was also concerned that the specimens were too old and the criteria used to determine a cardiovascular event at that time were not current. The FDA also expressed concern that the second group was not representative of the entire population and the results may have been biased.
LipoScience resubmitted the HDL-P filing last December, using data from more recent clinical studies. But in February the agency asked “for additional information from us.” LipoScience did not go into detail about what information the FDA is looking for but the company said that it is “actively working with the FDA to provide them with the requested information, and to resolve the issues they have identified.”
LipoScience will have to work through the regulatory issues with new leadership. The company disclosed this week that Vice President, Medical Affairs and Chief Medical Officer Robert Honigberg is resigning as of Sept. 17 for family-related reasons. LipoScience is also looking for a new CEO. Richard Brajer stepped down from the top post earlier this month. Robert Greczyn, a LipoScience board member and former CEO of Blue Cross Blue Shield North Carolina, has been named interim CEO.
