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Procter & Gamble (PG), Cleveland Clinic to Partner on Heart Disease Biomarker Development, Commercialization

August 20, 2015 10:36 AM EDT

Cleveland Clinic is collaborating with Cleveland HeartLab and Procter & Gamble (NYSE: PG) to develop and commercialize a diagnostic and management solution for a heart disease biomarker recently discovered by researchers in Cleveland Clinic's Lerner Research and Heart & Vascular Institutes.

As part of the collaboration, Cleveland HeartLab will develop a diagnostic test to measure blood levels of TMAO, or Trimethylamine-N-oxide, a substance produced by gut bacteria and that is linked to heart disease. Meanwhile, Cleveland Clinic researchers will work with Cincinnati-based P&G to develop an over-the-counter product that can help people manage their TMAO levels.

In 2011, a research team led by Dr. Stanley Hazen, vice chair of translational research at the Lerner Research Institute, discovered that elevated blood levels of TMAO are linked to enhanced risk of heart attack, stroke and death. Their studies also showed that TMAO directly contributes to the narrowing of artery walls through atherosclerotic plaque build-up. TMAO gets formed when a dietary nutrient called lecithin, which is most abundant in animal products rich in fat and cholesterol, gets metabolized by the natural bacterial flora in the gastrointestinal tract.

The initial findings were published in 2011 in Nature. Follow-up clinical studies were published in 2013 in the New England Journal of Medicine and Nature Medicine, leading to new insight into the connection between diet, gut bacteria and health. Findings help explain why, for some people, diets rich in foods like red meat, egg yolks and high-fat dairy products are more associated with increased cardiovascular risk. Numerous clinical studies now indicate that measuring TMAO levels can reveal heightened cardiovascular risks that standard tests, such as cholesterol and inflammation testing, tend to miss.

"The notion that the natural bacteria of the gut would make a substance that becomes a circulating factor related to the risk of heart disease was not on anyone's radar when Dr. Hazen's pioneering study was published," said Dr. Edward A. Fisher, director of the Center for the Prevention of Cardiovascular Disease at NYU School of Medicine. "This research is truly remarkable and has revealed a whole new level for researchers and industry to explore."

Since the discovery, Cleveland Clinic Innovations – the commercialization arm of Cleveland Clinic – has been working to license the biomarker as a clinical diagnostic test and to develop a solution for managing elevated TMAO levels.

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

Partnering with P&G is a logical strategy, Graham added, because the company has developed and distributed a number of health and wellness brands, including a new "Meta" line of wellness products that offer consumers an array of simple wellness solutions that can be easily incorporated into their lives.

Cleveland Clinic and P&G have entered into a Joint Development Agreement to develop an over-the-counter product that will help manage TMAO levels.

Meanwhile, Cleveland HeartLab has licensed the biomarker in order to offer TMAO testing. The company, a Cleveland Clinic spinoff, will validate the test in its CLIA-certified and CAP-accredited clinical laboratory. It intends to add the new test to its menu of advanced cardiovascular disease tests by the end of the year.

"This collaborative effort between nationally recognized leaders further illustrates Cleveland HeartLab's commitment to bring cutting-edge discoveries to clinicians who are eagerly looking for better tools to manage heart disease, the number one killer of men and women in the US," said Jake Orville, President and CEO of Cleveland HeartLab. "We have a strong history of innovation and are very pleased to collaborate with two global giants in healthcare—the Cleveland Clinic and Procter & Gamble—on this promising project."

TMAO has received widespread scientific and public attention since its discovery. In 2013, the American Heart Association and the American Stroke Association selected the discovery of the connection between gut flora, TMAO and cardiovascular disease risk as "a Top 10 advance in heart disease and stroke science."



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