CLEVELAND, Aug. 20, 2015 /PRNewswire/ -- 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."
About Cleveland Clinic Innovations
Cleveland Clinic Innovations is responsible for company
creation, business development and commercialization of all medical
technology throughout Cleveland Clinic and its Global Healthcare
Innovations Alliance partners. Since it was founded in 2000,
Cleveland Clinic Innovations has executed over 450 licenses and
created 75 spin-off companies that have raised over $1 billion in equity investment and
commercialization grants. These efforts have resulted in the
creation of over 1,200 jobs. Visit us at
www.clevelandclinic.org/innovations.
About Procter & Gamble
P&G serves nearly five billion people around the world with
its brands. The Company has one of the strongest portfolios of
trusted, quality, leadership brands, including Always®, Ambi Pur®,
Ariel®, Bounty®, Charmin®, Crest®, Dawn®, Downy®, Fairy®, Febreze®,
Gain®, Gillette®, Head & Shoulders®, Lenor®, Olay®, Oral-B®,
Pampers®, Pantene®, SK-II®, Tide®, Vicks® and Whisper®. The P&G
community includes operations in approximately 70 countries
worldwide. Please visit http://www.pg.com for the latest news
and in-depth information about P&G and its brands.
About Cleveland HeartLab
Cleveland HeartLab Inc. is the premier cardiovascular disease
(CVD) Management Company with a comprehensive array of propriety
tests focused on improving the early identification of those with
CVD risk. In addition to its industry leading approach to
inflammation testing, CHL manages a robust R&D program to
accelerate the clinical use of scientifically proven and medically
relevant biomarkers. CHL's biomarkers have been validated in
more than 100 peer-review studies published in leading medical and
scientific journals. Formed in 2009 as a spin-off from the
Cleveland Clinic, CHL offers its testing to thousands of leading
clinicians focused on health and wellness as well as corporate
wellness plans through its CAP-accredited and CLIA-certified
clinical lab. Half of all patients who suffer from heart
attack have normal cholesterol. With the goal of improving CVD risk
assessment, CHL's unique testing provides a more complete picture
of CVD risk allowing clinicians to deploy personalized medical
programs and interventions to reduce the overall risk of CVD, with
a specific focus on reducing the risks of inflammation. In a 2015
Journal of Medical Economics study on the economic impact of
CHL's core inflammation tests, CHL's CVD management protocol
demonstrated the potential to avoid nearly 10% of heart attacks and
strokes for patients of average health. The cost of care averted
was estimated to exceed $187 million.
CHL holds over 20 issued and 30 pending global patents and has been
recognized for its innovation with the prestigious Nortech
Innovation Award, The Ohio Venture of the Year Award and the
Edison Crystal Award for Excellence.
CHL was also named an "Inc. 5,000" company in recognition of its
innovation and growth. For more information about CHL
visit us at www.clevelandheartlab.com. For more information
on CVD visit www.knowyourrisk.com.
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SOURCE Cleveland HeartLab