Backed by promising academic research results, LipoScience ($LPDX) says it will begin clinical development of a new cardiovascular disease diagnostic test that gets the job done by screening for levels of a unique gut flora.
The North Carolina company said it would proceed after a Cleveland Clinic-led test that confirmed in part that higher fasting plasma levels of trimethylamine-N-oxide (TMAO) are connected to cardiovascular problems including strokes, heart attack and death. Also, their trial reaffirmed the link between the ingestion of phosphatidylcholine and dietary choline (found in meat, eggs, liver and wheat germ) and TMAO generation in the body. Details are published in the New England Journal of Medicine.
The test will be a personalized nuclear magnetic resonance diagnostic. LipoScience has previously developed its NMR LipoProfile test, a diagnostic that uses NMR detection to screen a patient's low-density lipoprotein particle number from a blood sample to help personalize how physicians treat patients at risk for heart disease. It centers on the company's FDA-cleared Vantera clinical analyzer.
The researchers didn't act on their own, of course. LipoScience licensed the technology behind its hoped-for TMAO diagnostic from the Cleveland Clinic. Lead researcher Stanley Hazen, a Cleveland Clinic physician and scientist, is, also, a paid consultant for LipoScience and has developed other cardiovascular diagnostics tech patents at Cleveland Clinic, the company notes. But LipoScience and the researchers said that the results are promising and warrant an advance in the company's clinical development plans.
"This presents opportunities to advance the diagnosis and treatment of cardiovascular disease risks," Hazen said in a statement. "To enable the expansion of research on TMAO and eventual market access, a widely available and efficient diagnostic assay for the metabolite is needed. We are working closely with LipoScience to develop an NMR-based assay to detect TMAO that will provide the research community and eventually practicing clinicians, with this tool."
The decision to launch a diagnostic clinical trial comes after LipoScience went public in January, raising $40 million in an IPO.
- read the release
- here's the NEJM abstract