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Coming Soon to a Doctor Near You? A Simple Test Can Tell if You’re Likely to Develop Hypertension in the Future

Critical Diagnostics announced recently that the Journal of Hypertension published a study titled, “Soluble ST2 Predicts Elevated SBP in the Community.” The results showed that a cohort of ostensibly healthy individuals, except for the presence of high levels of the biomarker ST2 in their blood, were almost twice as likely to develop hypertension in the future than those with low ST2 levels.

The implications of this finding are enormous. With this knowledge in hand, one day physicians may be able to offer their patients tailored treatment options as part of a preventative approach to medicine that could delay or even forestall the onset of hypertension entirely.

Hypertension, commonly referred to as high blood pressure, is a serious medical condition, affecting one out of every three adults over the age of 18 years. Hypertension is the leading risk factor for the development of heart failure. Men with high blood pressure are two times as likely to advance to heart failure, and for women with high blood pressure, the risk is three fold.

In 1948, the Framingham Heart Study – under the direction of the National Heart Institute (now known as the National Heart, Lung, and Blood Institute) embarked on an ambitious project to identify causes of heart disease and stroke, about which little was known at the time. The researchers recruited 5,209 men and women between the ages of 30 and 62 from the town of Framingham, Massachusetts, and began the first round of extensive physical examinations and lifestyle interviews that they would later analyze for common patterns related to cardiovascular disease development. In 1971, the Study enrolled a second generation – 5,124 of the original participants’ adult children and their spouses – to participate in similar examinations.

Study investigators evaluated 1,834 individuals from this Framingham Offspring Study Cohort to determine the predictive utility of ST2. The participants were followed over a period of three years. The results illustrated that those subjects whose ST2 level was elevated had a significantly greater chance of becoming hypertensive.

In numerous peer-reviewed publications, elevated concentrations of ST2 have been shown again and again to be associated with a worse prognosis and adverse disease progression in patients with heart failure. Moreover, in a recent publication involving the same Framingham cohort, ST2 identified those otherwise healthy individuals with the highest risk of developing heart failure as much as 10 years before the presence of any symptoms. In fact, ST2 was, by far, the most predictive of any biomarker tested.

“The encouraging data in this recent study highlights the clinical utility of ST2 beyond the management of heart failure,” notes David Geliebter, CEO of Critical Diagnostics. “The findings are profound and again support the potential role of ST2 in primary disease prevention, as it allows for the early identification of risk for cardiovascular disease in apparently healthy individuals which presently goes undetected until they are symptomatic, which is far too late.”

“ST2 is emerging as an important mediator of ventricular remodeling, as well as a valuable prognostic marker in cardiovascular disease,” state the authors. “Our findings support a robust link between sST2 and multiple [blood pressure] measures.”

“Critical Diagnostics’ primary objective is to leverage the scientific and clinical evidence in these types of studies,” adds James Snider, President of Critical Diagnostics, “and ultimately pursue additional clearances for use of ST2 in these varied clinical settings to improve health and the costly management associated with cardiovascular diseases.”

Study: Soluble ST2 Predicts Elevated SBP in the Community

Source: Critical Diagnostics

University of Maryland Medical Center Launches Genetic-testing Program for Cardiac Stent Patients

Patients with coronary artery disease who undergo treatment at the University of Maryland Medical Center now can receive long-term therapy based on information found in their genes. As part of a new personalized medicine initiative, the medical center is offering genetic testing to help doctors determine which medication a patient should take after a stenting procedure in order to prevent blood clots that could lead to serious – and potentially fatal – heart attacks and strokes.

Patients with suspected heart disease undergo coronary catheterization to identify blocked or narrow arteries. Tiny tubes, or stents, are often placed in the arteries to keep them open, and, after surgery, patients typically take antiplatelet drugs, such as clopidogrel (Plavix), to prevent platelets – blood cells produced in bone marrow – from sticking together and forming clots.

Now, patients who undergo coronary catheterization at UMMC and the Baltimore VA Medical Center, both of which are affiliated with the University of Maryland School of Medicine, can elect to be tested for variations in a gene called CYP2C19. Up to one-fourth of the U.S. population carries at least one abnormal copy of the CYP2C19 gene, and research has shown that as a result, these individuals do not metabolize the standard anti-clotting medication clopidogrel effectively.

“There is strong clinical data to support pharmacogenetic testing in regard to antiplatelet therapy,” says Alan R. Shuldiner, M.D., the John L. Whitehurst Endowed Professor of Medicine, associate dean for personalized medicine and director of the Program in Personalized and Genomic Medicine at the University of Maryland School of Medicine. “It’s time to incorporate genetics into the complex medical decisions that we make on behalf of our patients.”

In 2009, Dr. Shuldiner led a University of Maryland study, published in JAMA, which showed that patients with a CYP2C19 gene variation exhibited reduced clinical benefit from taking clopidogrel. Based on growing clinical evidence reported in Dr. Shuldiner’s study and others, the U.S. Food and Drug Administration issued a warning about the reduced efficacy of clopidogrel in people with the genetic variation.

“Pharmacogenetic testing enables us to tailor drug treatments to individual patients based on their unique genetic makeup, or genotype,” says Dr. Shuldiner, an endocrinologist and geneticist. “With genotype-directed therapy, we have the ability to change the ‘one size fits all’ approach to prescribing medication and ultimately improve the quality of care we provide to our patients. Patients want personalized and individualized medicine. They seek it out.”

The test is performed by analyzing the patient’s DNA, isolated from a blood sample, in a new state-of-the-art translational genomics laboratory at the University of Maryland School of Medicine. The tests are being conducted as part of a National Institutes of Health (NIH)-funded study to determine the best way to implement genetic-testing programs. Tests are free, and because of the partnership between UMMC and the University of Maryland School of Medicine, results are available within a few hours.

Dr. Shuldiner explains that the ability to provide test results within hours is crucial because cardiac stent patients are at risk for developing blood clots and other complications soon after they have the procedure. “This rapid turnaround time sets our program apart from other programs and commercial laboratories, where results may not be available for up to two weeks,” he adds.

Pharmacogenomics – how genes affect a person’s response to drugs – is a burgeoning area of research, but only a small number of hospitals in the United States have programs to offer routine genetic testing as part of their clinical practice. This new approach to patient care is part of the University of Maryland School of Medicine’s pursuit of more individualized, or personalized, medical treatment.

E. Albert Reece, M.D., Ph.D., M.B.A., vice president for medical affairs at the University of Maryland and the John Z. and Akiko K. Bowers Distinguished Professor and dean of the University of Maryland School of Medicine, says, “Personalized medicine is the future of health care, and we want to be at the forefront of not only advancing the science of genomics, but also using that knowledge in a clinical setting for the benefit of patients. Our Program in Personalized and Genomic Medicine, under Dr. Shuldiner’s direction, is helping to lead the way with this new genetic-testing initiative, created in partnership with the University of Maryland Medical Center and the Baltimore VA Medical Center.”

The University of Maryland launched its initiative in conjunction with a multi-center implementation study, the Translational Pharmacogenetics Project, funded by the NIH Pharmacogenomics Research Network (U01HL105198). Five other major hospitals across the United States are taking part in the study to evaluate the process for building such pharmacogenetic-testing programs.

“We plan to share lessons learned at our respective sites and to develop best practices for implementation of pharmacogenetics in everyday clinical practice. We are putting together a toolbox that will be useful to other institutions,” says Dr. Shuldiner, who is leading the multi-center study. Cardiologists Mark R.Vesely, M.D., and Shawn W. Robinson, M.D., assistant professors of medicine at the School of Medicine who care for patients at UMMC and the Baltimore VA Medical Center, are co-investigators.

It is expected that the test for the CYP2C19 gene variation will become standard care for all patients who receive stents at both medical centers once the initial research phase is completed.

Cardiologists receive guidelines on how to interpret the test results and recommendations for choosing medications. It is up to them to determine the most appropriate treatment for their patients, who might have other medical conditions that need to be considered. The test results also are entered in the electronic medical record, where they can be accessed by other physicians.

“Knowing a patient’s genotype is helping us to make more informed decisions for our patients,” Dr. Vesely says. “A combination of aspirin and clopidogrel is the routine choice of medications many physicians will prescribe for their stent patients. But patients who are likely to have a poor or moderate response may be better protected by other medications or possibly a higher dose of clopidogrel. It comes down to what is best for each patient.”

According to Dr. Vesely, limitations for the alternative medications include their association with higher bleeding rates. “The cost of the medications could also be a factor if patients cannot afford alternative medications or will not take them as prescribed.” Newer anti-clotting medications, such as prasugrel (Effient) and ticagrelor (Brilinta), are more expensive than Plavix, which has been available as a generic since May 2012.

Dr. Robinson notes that the response from patients to genetic testing has been positive. “Patients have been very receptive to discovering this new information about themselves that can possibly have a positive impact on their future cardiovascular health,” he says.

Dr. Shuldiner anticipates that the initiative will be expanded to include tests for other genes that may affect how patients respond to medications such as warfarin, an anticoagulant; simvastatin, a cholesterol-lowering drug; and codeine, a pain reliever. “Providing tailored therapy will better meet the health needs of patients and reduce the harmful side effects that can occur when a person is taking the wrong medication,” he says.

The University of Maryland School of Medicine’s Personalized and Genomic Medicine Program was established in April 2011 to help facilitate the pace of discovery in personalized and genomic medicine; to accelerate the translation of these new discoveries to improve patient care; and to enhance the training and education of future generations of physicians and scientists. The program is funded jointly by the School of Medicine and University of Maryland Medical Center.

Source: University of Maryland Medical Center

Health Diagnostic Laboratory, Inc.’s New Diabetes Prevention & Management Panel Incorporates Discovery from Metabolon Researchers

Health Diagnostic Laboratory, Inc., a CLIA-certified laboratory specializing in advanced cardiovascular and metabolic disease testing and health management, has launched a new blood test for stratifying prediabetic patients based on the Quantose™ insulin resistance markers discovered by Metabolon, Inc.

Insulin resistance is a primary risk factor for type 2 diabetes and cardiovascular complications, and the Quantose biomarkers have been incorporated into HDL, Inc.’s newly launched Diabetes Prevention & Management Panel, or DPMP. Following a soft-launch period of limited release, development, and test marketing, HDL, Inc. has incorporated the Quantose™ metabolites seamlessly into DPMP, a 21-test panel available to physicians nationwide beginning this month. Terms of the deal were not disclosed.

“The ability to more accurately identify patients likely to progress to full-blown type 2 diabetes is a powerful tool to help manage the onset of a leading cause of heart disease,” said Tonya Mallory, HDL, Inc.’s President, CEO and Co-founder. “The Quantose markers help complete Health Diagnostic Laboratory’s DPMP and provide physicians with a more accurate, deeper look at the root causes of prediabetes and diabetes.”

Diabetes affects 25.8 million people in the U.S., or 8.3 percent of the population, according to the American Diabetes Association. Nearly one in three U.S. adults – almost 80 million people – meet the criteria for prediabetes.

The Quantose™ biomarkers are novel metabolites detected in blood that reflect insulin resistance and detect progression to prediabetes and diabetes earlier than traditional glycemic measures such as HbA1c. By considering insulin resistance, metabolites provide clinicians with a useful tool that goes beyond traditional measures to stratify patients based on their risk for developing diabetes. The Quantose™markers are particularly useful in identifying prediabetic patients at the greatest risk of disease progression where drug or other interventional therapy may be appropriate. Such a clinical value is well-aligned with American Diabetes Association guidelines, which recommend physicians consider pharmaceutical intervention in high-risk prediabetic patients.

”We are delighted to have an ideal partner in Health Diagnostic Laboratory to bring American clinicians a new tool for identifying and managing patients at risk for developing diabetes,” said John Ryals, CEO of Metabolon. “Our expertise in biochemical profiling is reflected in the discovery of the Quantose markers and represents the culmination of many years of research by our scientists. Importantly, if physicians are able to detect high-risk prediabetic patients earlier, it may allow them to initiate therapeutic interventions capable of preventing diabetes and related complications. The launch of Health Diagnostic Laboratory’s DPMP using the Quantose markers also represents a significant milestone in Metabolon’s evolution from providing biomarker analysis services to discovering cutting-edge metabolomic-based diagnostic markers.”

Source: PR Newswire

Biomarker Predicts Organ Rejection and Death in Heart Transplant Patients

Critical Diagnostics announced recently the recently-published results of a Utah Transplantation Affiliated Hospitals Cardiac Transplant Program study involving the use of a novel biomarker, ST2, to monitor heart transplant patients for rejection. Subjects with the highest levels of ST2 had a more than 3-fold increase in the risk for death than those with the lowest ST2 levels. Moreover, this risk was present early and sustained from the time of initial blood draw to many years forward.

Just over 45 years ago, on December 3, 1967, Dr. Christian Barnhard transplanted the first human heart into 53-year old Lewis Washkansky, a South African grocer dying of chronic heart disease. After his surgery, Washkansky was given drugs to suppress his immune system, but they also left him vulnerable to deadly infections. He died 18 days later from double pneumonia.

Medicine has come a long way since then. Worldwide, over 3,500 heart transplants are performed annually, more than half in the U.S. Post-transplant survival rates now average 15 years, yet rejection and death are still all too common.

Currently, biopsy-driven diagnoses are used to predict transplant organ rejection, but this type of procedure is costly, involves risk, and offers little consideration of the underlying biological processes that predict the presence or severity of rejection and/or likelihood of adverse consequences.

In the ST2 study (“Interleukin receptor family member ST2 concentrations in patients following heart transplantation”), a total of 241 transplant patients were followed for a period of just over 7 years, during which time there were 62 deaths, or some 25 percent. The prognostic ability of ST2 was examined for both rejection and death. ST2 concentrations were measured approximately a month after transplantation and found to be highly predictive of short-, intermediate-, and longer-term outcomes.

“A monitoring strategy for the rejection that directly relates to its underlying pathophysiology would be an attractive choice,” notes the study authors. “Biomarkers reflective of rejection are an option . . . a novel biomarker candidate worthy of consideration for this application is ST2.”

Study: Interleukin receptor family member ST2 concentrations in patients following heart transplantation.

Source: Critical Diagnostics

Major Advance Provides Human Embryonic Stem Cells for Personalized Medicine

Somatic cell nuclear transfer (SCNT) is a technique in which the nucleus of a donor cell is transferred to an egg cell whose nucleus has been removed, generating embryos that are almost an identical genetic match to the donor individual. For the first time, a team of scientists has used SCNT to produce human embryonic stem cells (hESCs). This milestone, published by Cell Press May 15th in the journal Cell, opens up new avenues for using stem cells to understand patient-specific causes of disease and for developing personalized therapies.

“Our finding offers new ways of generating stem cells for patients with dysfunctional or damaged tissues and organs,” says senior study author Shoukhrat Mitalipov of Oregon Health & Science University. “Such stem cells can regenerate and replace those damaged cells and tissues and alleviate diseases that affect millions of people.”

Another technique that has been used to generate patient-specific stem cells to model diseases is called induced pluripotent stem cells (iPS) cells, which are generated directly from the patient’s somatic cells by adding a cocktail of cellular factors to stimulate regression to a stem cell state. However, concerns that this technique may generate unexpected mutations in the stem cells means that researchers are still keen to find ways to generate hESCs by other means.

In the past, researchers have used SCNT to generate only mouse and monkey embryonic stem cells—immature cells that can develop into different types of specialized cells, from neurons to heart muscle cells. Most previous attempts failed to produce human SCNT embryos that could progress beyond the 8-cell stage, falling far short of the 150-cell blastocyst stage that could provide hESCs for clinical purposes. Until now, it was not clear which factors and protocols are important for promoting SCNT embryonic development.

To overcome these hurdles, Mitalipov and his team started in familiar territory, refining methods for producing monkey SCNT embryos. Using these optimized protocols, they transferred nuclei from human skin cells into the cytoplasm of human egg cells, generating blastocysts that gave rise to hESC colonies. The resulting hESCs resembled those derived from fertilized embryos, had no chromosomal abnormalities, showed normal gene activity, and were capable of turning into more specialized cell types that could be used for replacing damaged tissues.

Surprisingly, the best outcomes came from donors who produced a low number of high-quality egg cells. “It was thought that, to make human SCNT work, many thousands of human eggs would be needed,” Mitalipov says. “We were able to produce one ESC line using just two human eggs, which would make this approach practical for widespread therapeutic use.”

Study: Human embryonic stem cells derived by somatic cell nuclear transfer

Source: EurekAlert!