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Cardiac Biomarker ST2 Proves Far Superior To Galectin-3 In A Head-to-Head Study

Critical Diagnostics recently announced that the study, “Head-to-head comparison of two myocardial fibrosis biomarkers for long-term heart failure risk stratification: ST2 vs. Galectin-3”, recently published online in JACC (the Journal of the American College of Cardiology) comparing the company’s novel cardiac biomarker ST2 to Galectin-3 (Gal-3), a biomarker from BG Medicine (NASDAQ: BGMD), found ST2 to be superior.

Critical Diagnostics’ Biomarker ST2 Included in the 2013 ACC/AHA Guidelines for the Management of Heart Failure

Critical Diagnostics announced today that the American College of Cardiology Foundation/American Heart Association Task Force jointly released its expanded clinical practice guideline for the management of patients with heart failure and has identified 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.”

The American College of Cardiology Foundation (ACCF) and the American Heart Association (AHA) have jointly produced guidelines in the area of cardiovascular disease since 1980. The guidelines are designed to assist clinicians in selecting the best management strategy for heart failure patients, and have been adopted by most U.S. cardiologists and followed by many other countries in developing their practice guidelines.

“Having ST2 included in the 2013 ACC/AHA Guidelines is unprecedented,” notes David Geliebter, CEO of Critical Diagnostics. “We only received FDA clearance in December of 2011. No cardiac biomarker that we know of has ever achieved this acceptance so quickly.”

Source: Critical Diagnostics

Cardiac Biomarker ST2 Identifies Chronic Heart Failure Patients to Benefit from High-dose Beta Blocker Therapy

Critical Diagnostics, makers of the Presage® ST2 Assay, announced today that during a presentation this week at the American College of Cardiology Scientific Sessions in San Francisco, the results of a study conducted through the Massachusetts General Hospital, Circulating Concentrations of Soluble ST2 Identify Benefit of High Dose Beta Blocker in Chronic Heart Failure: Results from the ProBNP Outpatient Tailored Chronic Heart Failure Therapy (PROTECT) Study, highlighted the cardiac biomarker ST2’s ability to identify those patients most likely to benefit from high-dose beta blockers and reduce risk from cardiovascular complications.

The 151 study participants were followed for 10 months and ST2 levels were measured using the Presage® ST2 Assay. Individuals with high ST2 concentrations and low beta blocker dose were more than four times as likely to result in a cardiovascular event and the least likely to survive, than those with low ST2 concentrations and high beta blocker dosage. Furthermore, ST2 levels “predicted time-to-first cardiovascular event above and beyond NT-proBNP and baseline clinical characteristics.”

“The findings of this study provide the foundation of ST2 in guiding personalized therapy for chronic heart failure patients,” notes Dr. James Snider, President of Critical Diagnostics. “ST2 is unlike any biomarker in heart failure because of its enduring prognostic strength, but now, as evidenced by the encouraging results from this study, ST2 holds the final link in potentially improving outcomes for heart failure patients through its unique ability to identify those who can benefit most from high-dose beta blocker treatment.”

“This is where the rubber meets the road in heart failure management,” exclaimed David Geliebter, Chairman and CEO of Critical Diagnostics. “While one aspect in heart failure management is to identify those patients at highest risk, it is just as important, however, if not crucial, to have the ability to measure progress in the selected treatment. ST2 continues to build evidence as the most versatile, prognostic cardiac biomarker in heart failure.”

Source: Critical Diagnostics

Cardiac Biomarker ST2 Identifies Chronic Heart Failure Patients To Benefit from High-Dose Beta Blocker Therapy

Critical Diagnostics, makers of the Presage® ST2 Assay, announced recently that during a presentation this week at the American College of Cardiology Scientific Sessions in San Francisco, the results of a study conducted through the Massachusetts General Hospital, Circulating Concentrations of Soluble ST2 Identify Benefit of High Dose Beta Blocker in Chronic Heart Failure: Results from the ProBNP Outpatient Tailored Chronic Heart Failure Therapy (PROTECT) Study, highlighted the cardiac biomarker ST2’s ability to identify those patients most likely to benefit from high-dose beta blockers and reduce risk from cardiovascular complications.

Clinical Advantages of Critical Diagnostics’ Cardiac Biomarker ST2 Featured In YouTube Video

Critical Diagnostics, makers of the Presage® ST2 Assay, recently announced that a six-minute videotape by Antoni Bayes-Genis, MD PhD., head of Cardiology Service at Hospital Germans Trias i Pujol, in Barcelona Spain discussing results of a study just completed on the use of biomarkers over conventional clinical assessments for risk stratification of heart failure patients has been posted on YouTube for immediate viewing.

The study followed 876 heart failure patients with a mean age of 70.3 years for a period of 40 months. During this follow up period, 311 patients died. Researchers compared 11 clinical variables, including age, sex, ischemic etiology of heart failure, left ventricular ejection fraction, New York Heart Association functional class, diabetes, renal function, beta blocker treatment, ace inhibitor treatment, sodium and hemoglobin biomarkers, which are routinely used to stratify heart failure risk against three biomarkers: NT-proBNP from Roche (OTC: RHHBY), high-sensitivity troponin T and Critical Diagnostics’ ST2.

The results from this recent study highlights the enduring clinical utility of ST2 despite being combined with the established and widely accepted cardiac biomarkers, like NTpro BNP, in medical practice. “The best results were obtained for ST2 and high-sensitivity troponin T,” notes Dr. Bayes-Genis, the primary investigator of the study. “Whenever we added NT-proBNP to these other two biomarkers, net reclassification improvement was reduced.”

Check out the video below.

“We are seeing strong adoption of ST2 by leading cardiologists who understand many of the limitations of utilizing natriuretic peptide markers like BNP and NT-proBNP in their practice,” states David Geliebter, CEO of Critical Diagnostics. “Natriuretic peptide markers certainly have their role in diagnosing heart failure, but fall short in guiding treatment of diseased patients. In study after study, ST2 has consistently demonstrated improved accuracy of patient prognosis over natriuretic peptide markers alone.

“Two of the biggest criticisms we hear about natriuretic peptide markers are that their levels don’t change or change too slowly, so their value as a serial marker for guiding treatment is questionable and, furthermore, that results are often skewed by other influencers such as age, gender, body mass index, atrial fibrillation, history of heart failure, anemia and impaired renal failure. By comparison, ST2 levels change rapidly in response to changes in the patient’s condition—sometimes within hours—thus helping physicians make informed decisions on an appropriate course of action to take and, if needed, to quickly adjust care, such as titrating medication. Moreover, unlike natriuretic peptide markers, ST2 levels are not adversely affected by the above-mentioned confounding factors.”

“Heart failure has become a growing public epidemic, with increasing incidence and prevalence,” Dr. Bayes-Genis stresses. “As a result, there is a need to understand risk factors and risk stratifiers, to better identify the patients that are going to have a better or a worse outcome. We now have a new generation of biomarkers, high-sensitivity troponin T and ST2, which are easily measurable in our routine practice, which provide additional information to stratify the prognosis of patients with heart failure.”

Source: Critical Diagnostics