Diagnostic company LipoScience has begun the clinical development phase of a diagnostic test based on the gut flora metabolite, trimethylamine-N-oxide (TMAO).
The nuclear magnetic resonance (NMR)-based TMAO assay is expected to detect future cardiovascular risks.
Clinical study, Intestinal Microbial Metabolism of Phosphatidylcholine and Cardiovascular Risk, has shown that plasma levels of TMAO can predict future cardiovascular events.
Cleveland Clinic Miller Family Heart and Vascular Institute Preventive Cardiology & Rehabilitation section head and principal investigator Stanley Hazen said 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," Hazen added.
In August 2011 LipoScience had signed an exclusive licensing agreement with Cleveland Clinic to develop and commercialize a diagnostic test for cardiovascular disease.
LipoScience chief executive officer Richard Brajer said the 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.
"We are closely collaborating with Cleveland Clinic to develop a TMAO assay based on NMR technology to help accelerate this needed and important area of research, and we expect to offer a clinical version of the TMAO test to practicing physicians in the future," Brajer added.