SAN DIEGO--(BUSINESS WIRE)--Critical Diagnostics announced today that the United States Patent and Trademark Office issued a patent in connection with its ST2 assay covering “Methods for Treatment of Cardiovascular Disease.”
“We are very pleased that the USPTO recognized the novelty and utility of our biomarker, ST2,” states James Snider, President of Critical Diagnostics. “Broadly speaking, this patent expands upon our existing patent portfolio to include utility in primary disease prevention around a method for treating patients to reduce their risk of developing a cardiovascular condition.”
In May of this year the company revealed publication of a research study that, for three years, followed a cohort of 1,834 otherwise healthy individuals, where those with high levels of the biomarker ST2 present in their blood were almost twice as likely to develop hypertension than those with low ST2 levels. Hypertension (high blood pressure) affects some 67 million people in the U.S. and is the leading cause of heart failure.
This study came out of the far-reaching Framingham Heart Study, under the direction of the National Heart Institute (now known as the National Heart, Lung, and Blood Institute) which, in 1948, embarked on an ambitious effort to identify causes of heart disease and stroke, about which little was known at the time. In 1971, the Study enrolled a second generation – just over 5,000 of the original participants' adult children and their spouses - to participate in similar examinations.
Data from this second generation Framingham cohort showed that otherwise healthy individuals with the highest levels of ST2 in their blood had the greatest risk of developing heart failure years before the presence of any symptoms. In fact, ST2 was, by far, the most predictive of any biomarker tested, including such established biomarkers as the natriuretic peptides and troponin.
It was late last year that another study, this one conducted through the Mayo Clinic and Foundation, once again proved the remarkable accuracy of ST2 in predicting the risk of heart failure and mortality in the general population. The study of 1,831 healthy individuals from Olmsted County, Minnesota, who were followed for approximately a decade, showed that those with the highest ST2 concentrations were at the most risk of heart failure or death over this same period of time.
“The implications of these research findings from both Framingham and Olmsted are enormous,” notes David Geliebter, CEO of Critical Diagnostics. “They indicate that the onset of hypertension or heart failure are not a certainty, that risk can be attenuated, and with this knowledge in hand, physicians may be able to offer their patients tailored treatment options as part of a preventative approach to medicine that can postpone or even prevent such life-threatening disorders.”
ST2 is a soluble protein expressed by the heart in response to disease or injury. It is reflective ventricular remodeling and cardiac fibrosis. ST2 is not adversely affected by confounding factors such as age, body mass index and impaired renal function. Unlike many other cardiac biomarkers, ST2 levels change quickly in response to changes in the patient’s condition—thus helping physicians make informed decisions on an appropriate course of action to take and, if needed, to quickly adjust treatment. All this makes ST2 an ideal serial biomarker for monitoring and treating heart failure patients.
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 in the risk stratification of chronic heart failure patients.
ST2 is included in the 2013 ACC/AHA Guideline For The Management of Heart Failure, which calls ST2 “not only predictive of hospitalization and death in patients with HF [heart failure] but also additive to natriuretic peptide levels in [its] prognostic value.”
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.