Cleveland Clinic Teams With Cleveland HeartLab, Procter & Gamble to Develop Heart Disease Biomarker Test

Sensing a big diagnostic business possibility, the Cleveland Clinic wants to learn the tao of TMAO.

That's short for trimethylamine-n-oxide. It is a metabolite that originates in the human digestive system. However, levels of TMAO in the blood are a strong indicator of heart disease in a patient—and therefore could make for a useful diagnostic tool.

As a result, the Cleveland Clinic is teaming up with the Cleveland HeartLab and consumer products giant Procter & Gamble to create not only a test for detecting TMAO in patients, but develop a therapeutic product that would be sold directly to consumers.

"The objective of the collaboration with (Procter) is the development of a consumer over-the-counter product that would help manage TMAO levels," said Mary Kander, who is coordinating the project on behalf of Cleveland Clinic's innovations arm.

According to Kander, both the Cleveland Clinic and Procter & Gamble are investing in the initiative. Any therapeutic that is developed would be distributed by Procter under a license from the Cleveland Clinic. Cleveland HeartLab, which is a Cleveland Clinic spinoff, will develop the diagnostic and offer it to patients as an advanced cardiovascular test. It is expected to be available before the end of the year, according to Kander.

The linkage between TMAO and heart disease and the risk of heart attacks was discovered by a Cleveland Clinic research arm four years ago. Its presence can determine whether the consumption of eggs, red meat and other foods high in cholesterol makes it more likely a patient will develop heart disease and its associated problems, or not.

"We knew early on that this discovery was of profound importance and could impact the lives of patients everywhere for the better," said Thomas Graham, the Cleveland Clinic's chief innovation officer, in a statement. "All stakeholders sought to find the right partnership to help realize the potential advancements in health and wellness promised by this discovery."

Graham noted in a statement issued by the Cleveland Clinic that Procter was chosen as a product development partner because of its experience marketing and selling over-the-counter health devices. The company recently retooled the Metamucil fiber beverage to include an entire line of food and probiotic products intended to increase the intake of fiber, which can be used to stave off heart disease.

Any therapeutic medication or device intended to manage TMAO levels could take longer to develop than the TMAO assay, as it would require approval by the U.S. Food and Drug Administration. Kander noted that there was a likelihood that the diagnostic could be available to consumers before any therapeutic.

Takeaway: The Cleveland Clinic is working to make available a consumerfriendly diagnostic and therapy to better manage heart disease.