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IMDEA Food and Metabolon, Inc. Announce Strategic Collaboration to Advance Nutrition-based Personalized Medicine

IMDEA Food, a Translational Research Institute from the Community of Madrid, dedicated to investigating the relationships among nutrition, food and health, and the US-based company Metabolon Inc., the pioneering leader in the field of metabolomics and molecular diagnostics serving the pharmaceutical and food industries, recently announced an ambitious collaboration program. The agreement, signed in Madrid by Dr. John Ryals, President and CEO of Metabolon, and Dr. Guillermo Reglero, Director of IMDEA Food, establishes the framework for future strategic projects aimed to develop functional foods and diagnostic tools.

Of particular interest are the prevention of prevalent chronic diseases with high societal impact, such as cardiovascular disease, cancer, obesity and neurological diseases, which are highly dependent on understanding food science and nutritional impact. To achieve this goal, individual in-depth studies to characterize the molecular mechanisms underlying the health benefits of foods and food components are needed.

“These studies promise to lead toward an efficient decrease of morbimortality due to chronic degenerative diseases and a better quality of life. IMDEA Food and Metabolon will combine their knowledge to advance towards this objective. A combined functional genomics and metabolomics approach involving complementary technologies and multidisciplinary expertise is paramount to achieve the scientific rigor and level of evidence required to bring nutrition-based personalized medicine to the public with the final objective of living longer and healthier”, commented Prof. Jose Ordovas of Tufts University, a world-renowned pioneer in nutrigenomics. Prof. Ordovas serves as the Senior Scientist and Director for the Nutrition and Genomics Laboratory and as the Chair of the Functional Genomics Core of the Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University. Since its inception in 2007 Prof. Ordovas has been Chairman of the Board and Scientific Director of IMDEA Food.

The IMDEA Food Institute carries out human nutrigenomic studies, which are reviewed by a Research Ethical Committee, on its platform comprised of common services for genomics, biostatistics, bioinformatics and nutritional counseling. Metabolon is the world leader in metabolomic analysis of complex biological samples and has made major contributions to the discovery of biomarkers and biochemical pathways associated with nutrients and drugs, and which have led to the development of unique diagnostic tools. Scientists from IMDEA Food and Metabolon have met in IMDEA Food’s new headquarters located in Madrid to define the lines of common interest and greatest priority and to launch the first of a series of studies aimed at defining the molecular basis of action of key food ingredients.

Dr. Steve Watkins, Chief Technology Officer, Metabolon commented, “Collaborative studies with IMDEA will employ the combined resources and expertise of our organizations to identify appropriate biomarkers of disease risk and prevention and to monitor biological impact of nutritional components in foods. This strategic collaboration is pivotal to advancing our understanding of nutrition’s influence on health and disease.”

Source: Business Wire

Decades of Improving Cholesterol Levels Abruptly Ended in 2008, PLOS ONE Study Finds

Decades of declines in LDL cholesterol blood levels, a key marker of death risk from heart disease, abruptly ended in 2008, and may have stalled since, according to a multi-year, national study published recently in PLOS ONE.

The study, by researchers at Quest Diagnostics (NYSE: DGX), examined low-density lipoprotein, or LDL, blood-serum cholesterol test results of nearly 105 million individual adult Americans of both genders in all 50 states and the District of Columbia from 2001-2011. The study is the largest of LDL cholesterol levels in an American population, and the first large-scale analysis to include data from recent years 2009-2011.

“Our study suggests that significant improvements in heart disease risk through declines in LDL cholesterol blood levels over the past several decades came to an unexpected and sudden end in 2008,” said investigator Robert Superko, M.D., medical director, cardiovascular disease, Quest Diagnostics. “The unprecedented scale of our data set should spur additional research to identify the cause or causes in order to prevent a possible reversal in years of gains in cardiovascular health in the U.S. population.”

The study found a net 13% decline in the annual mean LDL cholesterol level of the study population over the 11-year period. Between 2001 and 2008, the average age-adjusted mean LDL levels declined from about 120 mg/dL to 104.7 mg/dL, but plateaued at that level for the remainder of the study period. LDL levels of 100 mg/dL or lower are considered optimal by the American Heart Association. By 2011, about 46% of patients had achieved LDL levels lower than 100 mg/dL, while 6% of patients had LDL levels in the high-risk category of 160 mg/dL or higher.

Blood cholesterol levels are the primary biomarker for cardiovascular disease, which accounts for one in every three deaths in America. High levels of LDL (“bad”) cholesterol can cause arterial clogging, increasing the risk of stroke and heart disease. Treatments typically include lifestyle modification and therapy with lipid-lowering medications such as statins. Every 10 mg/dL decline in LDL is associated with an approximately 5-13% decline in major vascular disease events, such as strokes and mortality.

Prior research, including results of three National Health and Nutrition Examination Surveys (NHANES) of nearly 40,000 patients for the years 1988 to 2010, demonstrated that LDL levels have declined in the United States while the use of lipid-lowering medications has increased.

The Quest Diagnostics Health Trends study, “Blood Cholesterol Trends 2001-2011 in the United States: Analysis of 105 Million Patient Records,” was published online May 10, 2013 in the peer-reviewed, open-access journal PLOS ONE.

Theories for the LDL Plateau

The observational study in PLOS ONE did not identify a cause for the trends in LDL cholesterol blood levels, although investigators suggested several hypotheses.

“It is possible that the economic recession that began at about the same time LDL values plateaued in our study played a role. Patients dealing with financial constraints may have been less inclined to visit their physician or use their medications at full dose, limiting access to and effectiveness of treatment. Individuals may also have experienced changes in stress levels, diet, sleep and other behaviors, due to the poor economy, which in turn may have adversely impacted lipids,” said Harvey W. Kaufman, M.D., senior medical director, Quest Diagnostics.

The investigators also theorized that statins users in the study may have reached the maximum therapeutic-threshold level or that increases in obesity prevalence or other co-morbid factors during the 11 years of the study period contributed to the LDL plateau.

“These speculative, but plausible theories deserve additional research so the cause of the trend seen in our data can be addressed and hopefully reversed,” said Dr. Kaufman.

Gender Differences

The investigators also found differences in LDL cholesterol declines by gender. The decline in annual age-adjusted mean LDL cholesterol blood levels was slightly greater among men than women, with an average 13.4% decline for men compared to a decline of 12.5% for women.

“Though the differences are not statistically significant, they may reflect meaningful differences in the prescription rate and effectiveness of lipid-lowering interventions, including statins and lifestyles, between genders,” wrote investigators in the study. They also theorize that the differences may be due in part to “under-appreciation of heart disease risk in women,” given female-specific AHA guidelines and risk-classification algorithms for women were introduced only in 1999 and 2007, respectively.

Greater Vigilance Required

“Like other Quest Diagnostics Health Trends reports, our goal is to provide insights, based on diagnostic data, to enhance public health and patient management and, fundamentally, create a healthier world,” said Dr. Kaufman.

“We believe this new study will encourage additional population research to inform public health efforts. But we also believe the study should prompt individual patients to be vigilant about practicing healthy behaviors and lipid-lowering treatment plans. Our hope is physicians and patients will have more productive conversations about the importance of LDL control to cardiovascular health as a result of this study,” said Dr. Kaufman.

The study’s strengths include its size, national representation, longitudinal analysis and incorporation of data up through 2011. It also includes its separation of data into distinct years, as opposed to other large-scale studies, such as NHANES, which group findings into multiple years. The study represents patients under medical care and not the general American population and did not include results of clinical records, such as medical history and medications, to assess contributing factors to the results. The study examined test results of patients tested by Quest Diagnostics. Data was de-identified prior to analysis and the Western Institutional Review Board exempted the study from review.

Study: Blood Cholesterol Trends 2001–2011 in the United States: Analysis of 105 Million Patient Records

Source: Quest Diagnostics

Atherotech Diagnostics Lab Expands Heart Disease Atherotech Diagnostics Lab Expands Heart Disease Risk Assessment with AspirinWorks® Test

Atherotech Diagnostics Lab, a leading clinical reference laboratory specializing in cardiometabolic testing and disease management solutions, recently launched the AspirinWorks® Test to complement its menu of cardiovascular disease risk assessment tests.

More than 1 million Americans experience new or recurrent heart attacks each year. These at-risk individuals are candidates for aspirin therapy and should be tested for the presence or absence of the therapy’s effect. The AspirinWorks Test is used to determine levels of 11‑Dehydro Thromboxane B2 (11dhTxB2) in human urine, which aids a physician in the determination of aspirin effect.

“The AspirinWorks Test maximizes the value of our VAP Lipid Panel and accompanying line of cardiometabolic disease diagnostics and management tests,” Atherotech CEO Michael Mullen said. “This offering is strategically aligned with our company’s mission to proactively manage risk and guide therapy to help improve patient outcomes.”

Aspirin therapy works on blood platelets to decrease levels of thromboxane A2 (TxA2), a powerful stimulator of platelet aggregation. Lower thromboxane levels and decreased platelet aggregation means less chance of developing a blood clot, and therefore, less chance of a heart attack or stroke. However, studies have shown that for several reasons, up to 25 percent of individuals do not get the expected beneficial effect of aspirin.

The AspirinWorks Test identifies those individuals who have elevated thromboxane levels despite taking a daily aspirin dose.

“The added information from the AspirinWorks Test will help provide a more accurate and complete evaluation of a patient’s cardiovascular health,” Atherotech Chief Medical Officer Michael Cobble, M.D., said. “Assessment of the chemical marker for platelet aggregation facilitates a strategic, scientifically validated approach to maximizing the value of aspirin therapy and minimizing the risk of heart attack and stroke.”

The AspirinWorks Test has been clinically validated through extensive research and numerous well-designed and well-powered clinical trials. The AspirinWorks Test is FDA cleared and used to test and guide treatment for hundreds of thousands of patients each year worldwide.

Atherotech provides a full complement of more than 60 routine and specialty diagnostic tests, including its patented VAP® Lipid Panel to help physicians establish the most effective course of treatment from a single source.

Source: Atherotech Diagnostics

Genophen Taps NextBio Clinical to Incorporate Genomic Data into Disease Risk Software

NextBio recently announced that it has formed a partnership with Genophen, a Stanford University spinout, which will focus on generating personalized disease prevention and wellness plans for patients based on a combination of genomic, clinical, environmental, and behavioral data.

Specifically, Genophen is partnering with NextBio so that it can use the NextBio Clinical platform to analyze genetic variants from whole genome sequence data and combine these with information on things like diet, family history, and exercise to create bespoke disease prevention plans for patients.

Genophen’s President and CEO Hossein Fakhrai-Rad told BioInform that the company tapped NextBio’s platform because it offered access to a curated database of genomic variants that are associated with various disease conditions, and because it expands Genophen’s own internally built repository. The arrangement also lets Genophen focus its efforts on disease risk assessment rather than spend time going through the literature and linking variants and diseases, he said.

Founded in 2008 at the Stanford Genome Technology Center, Genophen has developed a software system dubbed ‘the Genophen platform’ that uses a series of proprietary algorithms to assess patients’ risk of developing complex or multi-factorial diseases such as type II diabetes based on genetic, clinical, environmental, and behavioral information. The platform then provides personalized recommendations to help patients minimize their risk. The platform also prioritizes factors that increase patients’ risk based on their health profiles, and calculates how lifestyle changes could help reduce risk.

Genophen plans to launch its platform publicly in a few weeks, and it will include new features such as a new user interface, Fakhrai-Rad said. He added that in the last year his company has been putting the platform through its paces with a select group of physicians and patients via a pilot project and a currently ongoing beta test program.

The company has also partnered with Illumina’s CLIA laboratory to handle the whole-genome sequencing aspect of its business, Fakhrai-Rad said. Also, it is finalizing arrangements with a second CLIA lab that will offer genotyping services, which are less comprehensive than NGS but much cheaper, Fakhrai-Rad said.

In addition, Fakhrai-Rad stressed that the company will not offer a direct-to-consumer service, but will work in concert with physicians and genetic counselors who will be responsible for discussing a recommended course of action with patients and helping them make decisions about next steps.

For NextBio, the partnership with Genophen reflects a growing demand for its tools from healthcare providers who are looking to make it easier to use whole-genome and targeted sequencing data, NextBio CEO Saeid Akhtari told BioInform.

Historically, the company’s products have been patronized by customers in the pharmaceutical and biotechnology industries involved in drug research and development. However, since the launch of NextBio Clinical last April (BI 4/27/2012), it has begun to receive business from clients in the clinical market including cancer centers, hospitals, and diagnostic companies, Akhtari said.

For instance, last June the company announced that the Cancer Care Institute had licensed its product portfolio — which also includes the NextBio Research software — to analyze oncology patient data for research studies and to select appropriate treatments for patients based on their molecular profiles (BI 6/29/2012).

Earlier this year, Emory University’s Winship Cancer Institute and the Aflac Cancer Center of Children’s Healthcare of Atlanta tapped NextBio Clinical to support their partnership, which is focused on identifying biomarkers that can predict brain cancer metastasis in children in order to help clinicians determine which patients should receive radiation therapy (BI 1/25/2013).

And NextBio expects that the demand for its clinical software to continue to grow and even surpass demand from the pharma/biotech market over the next few years as more clinicians and patients continue to avail themselves of sequencing and molecular profiling technologies, Akhtari said.

The software is also holding its own, Akhtari said, against competing products such as KnomeClinic, a software suite launched by Knome for interpreting and annotating human genomes(BI 6/15/2012).

NextBio believes customers prefer its offering, according to Akhtari, because it provides access to analytic capabilities on private cloud infrastructure so that customers don’t have to purchase their own hardware; offers comprehensive curated content; and comes with an adaptive learning knowledgebase that uses newly incorporated information from patients to improve correlations between variants and disease. The company also updates its software and database content regularly in response to customers’ requests, he said.

Akhtari said that NextBio has potential deals currently going through an “approval process” with other companies besides Genophen, but declined to disclose who those new clients are.

Source: Genophen

New Evidence for Link Between Depression and Heart Disease

A Loyola University Medical Center psychiatrist is proposing a new subspecialty to diagnose and treat patients who suffer both depression and heart disease. He’s calling it “Psychocardiology.”

In his most recent study, Angelos Halaris, MD, PhD, and colleagues found that an inflammatory biomarker, interleukin-6, was significantly higher in the blood of 48 patients diagnosed with major depression than it was in 20 healthy controls. Interleukin-6 has been associated with cardiovascular disease. Halaris presented findings at a joint congress of the World Psychiatric Association and International Neuropsychiatric Association in Athens, Greece. At the congress, Halaris formally proposed creation of a new Psychocardiology subspecialty.

Forty to 60 percent of heart disease patients suffer clinical depression and 30 to 50 percent of patients who suffer clinical depression are at risk of developing cardiovascular disease, Halaris said.

Stress is the key to understanding the association between depression and heart disease. Stress can lead to depression, and depression, in turn, can become stressful.

The body’s immune system fights stress as it would fight a disease or infection. In response to stress, the immune system produces proteins called cytokines, including interleukin-6. Initially, this inflammatory response protects against stress. But over time, a chronic inflammatory response can lead to arteriosclerosis (hardening of the arteries) and cardiovascular disease.

It’s a vicious cycle: depression triggers a chronic inflammation, which leads to heart disease, which causes depression, which leads to more heart disease.

Clinical depression typically begins in young adults. “Treating depression expertly and vigorously in young age can help prevent cardiovascular disease later on,” Halaris said.

Physicians often work in isolation, with psychiatrists treating depression, and cardiologists treating cardiovascular disease. Halaris is proposing that psychiatrists and cardiologists work together in a multidisciplinary Psychocardiology subspecialty.

A Psychocardiology subspecialty would raise awareness among physicians and the public. It would forge closer working relationships between psychiatrists and cardiologists. It would formalize multidisciplinary teams with the requisite training and expertise to enable early detection of cardiovascular disease risk in psychiatric patients and psychiatric problems in heart disease patients. And it would provide continuing education to physicians in the safe and correct use of medications in cardiac patients who have psychiatric disorders.

“It is only through the cohesive interaction of such multidisciplinary teams that we can succeed in unravelling the complex relationships among mental stress, inflammation, immune responses and depression, cardiovascular disease and stroke,” Halaris said.

Source: EurekAlert!