LipoScience back to drawing board after FDA rebuff

LipoScience ($LPDX) has voluntarily withdrawn an FDA application for its heart disease diagnostic, the test's second setback in just over a year.

The company's diagnostic is designed to use patients' high-density lipoprotein particle (HDL-P) numbers to help manage the treatment of coronary heart disease, but its existing data apparently wasn't enough for the FDA, and LipoScience said in a regulatory filing that it would keep working with the agency and come back with more clinical results later. The company couldn't specify a timeline.

As the Triangle Business Journal notes, this isn't LipoScience's first spot of trouble with the test. The company yanked a similar application for FDA clearance last year after the agency took issue with two supporting studies, questioning whether the specimens and trial criteria were outdated, according to the Journal.

LipoScience jumped on the Nasdaq through a $40 million IPO back in January, riding strong results from its NMR LipoProfile test, a nuclear magnetic resonance detection test that can determine a patient's low-density lipoprotein particle (LDL-P) number from a blood sample. The test works on LipoScience's FDA-cleared Vantera analyzer, a device the company is working to expand around the world.

The company has had to weather some management upheaval since then, this month watching CEO Richard Brajer step down after 10 years and CMO Robert Honigberg depart for "family-related reasons," the Journal points out. LipoScience's shares have dropped nearly 52% to $5.08 since opening at $10.45 in January.

- read the filing
- check out the Journal story

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