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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

Evidence Grows For The Use of Critical Diagnostics’ Biomarker, ST2, In Primary Disease Prevention

SAN DIEGO, CA May 14, 2013 – Critical Diagnostics announced today 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.”


About ST2
ST2 is a member of the interleukin (IL)-1 receptor family, whose expression in cardiomyocytes is upregulated in response to stress. The membrane-bound form of ST2 interacts with IL-33 (released from fibroblasts), leading to anti-hypertrophic and anti-fibrotic effects in the myocardium. Soluble ST2 (sST2) consists of the extracellular domain of the ST2 molecule, and may act as a decoy receptor for IL-33, blocking myocardial and vascular benefits, experimentally leading to progressive myocardial remodeling and atherosclerosis, respectively. In in vivo studies, infusion of large amounts of soluble sST2 results in adverse cardiac remodeling, heart failure, and premature death. Clinical studies have further shown that the prognostic information from sST2 is independent of, and provides added information and value to, that of cardiac biomarkers commonly used today.

sST2 has been published in more than 100 peer-reviewed articles and scientific posters studying more than 40,000 patients. Critical Diagnostics holds numerous issued and pending international patents on ST2. The Presage® ST2 Assay from Critical Diagnostics is the only commercially available ST2 biomarker in the world. The Presage ST2 Assay has been CE Marked and cleared by the U.S. FDA for use as in the risk stratification of chronic heart failure patients.

About the Framingham Heart Study
For over 65 years, the Framingham Heart Study has helped scientists to unlock answers to many of medicine's most important questions and has led to the identification of the major cardiovascular risk factors including high blood pressure, high blood cholesterol, smoking, obesity, diabetes, and physical inactivity, as well as a great deal of valuable information on the effects of related factors such as blood triglyceride and HDL cholesterol levels, age, gender, and psychosocial issues.

About Critical Diagnostics
Founded in 2004, Critical Diagnostics (www.criticaldiagnostics.com) develops novel biomarkers to help physicians optimize patient care in cardiovascular diseases, while containing healthcare costs. Critical Diagnostics has distribution partners for its Presage ST2 Assay in 45 countries, covering two-thirds of the world’s population.

For More Information, Contact:
Dennis Dalangin, VP Marketing
Telephone: (877) 700-1250
Email: ddalangin@criticaldiagnostics.com