Medical Devices

Novel heart disease diagnostic would measure risk by testing the gut

healthy heart

The saying that the way to a man’s heart is through the stomach might be true in more ways than one. Diagnostics company LipoScience is developing a new cardiovascular disease test that would use gut flora as a biomarker for cardiovascular risks.

The novel approach is based on research licensed from the Cleveland Clinic. Researchers there discovered a link between the microbes found in people’s intestines and cardiovascular disease risk. Raleigh, North Carolina-based LipoScience will develop its new test using Cleveland Clinic’s discoveries regarding a gut flora compound known as trimethylamine N-oxide (TMAO).

Though the license agreement was reached last August, LipoScience did not disclose it until now. LipoScience gave no details on any financial terms but said it is a worldwide licensing agreement. It’s likely that Cleveland Clinic stands to gain royalties on future sales of a new LipoScience cardiovascular diagnostic.


LipoScience, which has yet to pull the trigger on its $86 million initial public stock offering plans, has developed technology based on nuclear magnetic resonance, or NMR. The company’s NMR detectors, or spectrometers, work by exposing a blood sample to a short pulse of radio frequency energy within a strong magnetic field. LipoScience has proprietary software that collects and analyzes the signals from the particles in a sample. The company has commercialized one NMR diagnostic — a blood test that counts lipoproteins in a sample to gauge the risk of cardiovascular disease. Cleveland Clinic is already familiar with LipoScience’s NMR technology. The clinic was one of LipoScience’s research collaborators in developing and testing the technology.

The company believes that the NMR approach will also work on gut flora. TMAO research to date has been conducted with mass spectrometry for detection, which LipoScience CEO Richard Brajer described in a statement as “a tedious and time-consuming method.” Brajer said that the properties of TMAO make it suited for detection by magnetic resonance.

Cleveland Clinic’s TMAO research was led by Dr. Stanley Hazen, professor of molecular medicine at Cleveland Clinic Lerner College of Medicine at Case Western Reserve University and vice chair of translational research at Cleveland Clinic’s Lerner Research Institute. The research was originally published in an April 2011 article in Nature that showed that gut flora demonstrated an impact on heart disease in both animals and humans.

“The discovery that gut flora can be a biomarker for cardiovascular disease could lead to incredible advances in testing,” Hazen said in a statement. “Using this discovery to help patients diagnose heart disease is very promising and can help improve clinical outcomes.”

[Photo Credit: freedigitalphotos user digital art]

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