Diagnostic firm LipoScience, in partnership with Cleveland Clinic, has commenced the clinical development phase of a diagnostic test for cardiovascular disease based upon the gut flora metabolite trimethylamine-N-oxide (TMAO).
LipoScience said the test is based on research that demonstrated that TMAO, a unique gut flora metabolite, is a predictor of cardiovascular risk.
Development and commercialisation of the proposed test was originally finalised under an exclusive licensing agreement signed by Cleveland Clinic with LipoScience in August 2011.
As part of the deal, LipoScience plans to utilise its Global Research Services (GRS) division to provide an NMR-based TMAO assay for research applications in the near term.
According to a study, published by Cleveland Clinic in the New England Journal of Medicine (NEJM), TMAO is generated in humans from dietary choline and phosphatidylcholine that are rich in foods such as meat, eggs, liver and wheat germ.
Led by Stanley Hazen, vice chair of Translational Research for the Lerner Research Institute and section head of Preventive Cardiology and Rehabilitation in the Miller Family Heart and Vascular Institute at Cleveland Clinic, the researchers concluded that plasma levels of TMAO can predict future cardiovascular events.
Commenting on the test, Dr Hazen said the development and progression of atherosclerosis has only recently been suggested, presenting opportunities to advance the diagnosis and treatment of cardiovascular disease risk.
"To enable the expansion of research on TMAO and eventual market access, a widely available and efficient diagnostic assay for the metabolite is needed," Hazen said.
"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."
In addition to identifying the relationship between the oral intake of phosphatidylcholine and the involvement of intestinal bacterial pathway of TMAO, the study also draws relationship between fasting plasma levels of TMAO and incident major cardiovascular events.
LipoScience chief executive officer Richard Brajer said; "This study identifies TMAO levels, which are a by-product of our diet, as an independent contributor to cardiovascular events with potentially important clinical implications for advancing patient care".