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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.

Biomarker Assessment in Suspected ACS Could be Practice-changing: BIC-8 Results

An emergency department strategy that uses two biomarkers to triage patients with suspected acute coronary syndrome (ACS) can increase the rate of early, safe hospital discharge, according to results of the Biomarkers in Cardiology 8 (BIC-8) trial.

“This biomarker strategy using a state-of-the-art quantitative troponin assay in combination with an ultrasensitive copeptin assay has the potential to change clinical practice with high patient safety,” said lead investigator Martin Möckel, MD, PhD, from Charité – Universitätsmedizin Berlin, in Berlin, Germany.

“This is the first interventional trial to study whether it is safe to discharge suspected ACS patients who test troponin and copeptin negative at admission. Using this strategy, a high proportion of patients could be discharged early, thus unnecessary treatments and resources could be saved, causing a substantial benefit for patients and health care providers.”

Emergency departments worldwide face increasing overcrowding and patients with signs and symptoms which might be caused by an acute coronary syndrome are very common, even though only around 15% of these patients are ultimately diagnosed with an acute myocardial infarction as the underlying disease, explained Dr. Möckel.

“Rapid rule-out of acute myocardial infarction (MI) is therefore a major clinical need, saving the health care system time and resources and patients unnecessary stress, anxiety and other risks associated with hospitalization.”

Current guidelines recommend that patients receive serial troponin testing to confirm that hospital discharge is appropriate, but this testing delays definitive action, he said.

“The new biomarker copeptin has been shown to be elevated in patients first presenting with acute MI, and when combined with the cardiac troponin biomarker has an excellent negative predictive value for acute MI. However, an early discharge strategy based on combining these two tests has never been assessed prospectively.”

BIC-8, a multicentre, open, randomized, controlled clinical trial included 902 patients with an initial negative troponin test to assess this strategy.

In the experimental arm (n=451), patients with a negative copeptin test (less than 10 pmol/L) were discharged into ambulant care, with a scheduled outpatient visit within 72 hours, while those with a positive copeptin test received standard treatment according to current guidelines.

Among patients in the standard arm (n=451), copeptin results were not available to treating staff and patients were treated according to current guidelines.

At 30 days of follow-up the rate of major adverse cardiovascular events (MACE) was similar in both groups (5.46% in the experimental arm vs 5.5% in the standard arm), but emergency room discharge rates were significantly higher in the experimental arm (66% vs 12%; P < 0.001).

The results support the consideration of a new treatment algorithm in low-to-intermediate risk patients with suspected ACS, said Dr. Möckel.

“Patients with a negative troponin and a negative copeptin result at admission can safely be discharged if the final clinical assessment is consistent with this decision, as long as a timely diagnostic work-up is done in the outpatient setting,” he said.

However, the clinical judgment of the treating physician is of utmost importance, he stressed.

“If his or her final clinical assessment excludes discharge due to high suspicion of ACS, perhaps due to recurrent symptoms or an updated history, the patient should not be discharged despite negative biomarker results.”

Source: EurekAlert!

Sony DADC Develops Smart Consumables for Quanterix Simoa HD-1 Analyzer

Quanterix Corporation, delivering the world’s most sensitive single molecule immunoassay measurement for the benefit of human health, recently announced that the Simoa HD-1 Analyzer recently launched by Quanterix uses a “Smart Consumable” designed and manufactured by Sony DADC BioSciences called the Simoa Disc. For use in life science research today and in vitro diagnostics (IVD) markets in the future, the Simoa disc is used to achieve higher levels of sensitivity and precision and is the first diagnostic consumable whose assay technology is based on optical disc formats by Sony DADC.

Biomarker Predicts Heart Attack Risk Based on Response to Aspirin Therapy

Aspirin has been widely used for more than 50 years as a common, inexpensive blood thinner for patients with heart disease and stroke, but doctors have little understanding of how it works and why some people benefit and others don’t.

Now researchers at Duke Medicine have solved some of the mysteries related to the use of this century-old drug, and developed a blood-based test of gene activity that has been shown to accurately identify who will respond to the therapy.

The new gene expression profile not only measures the effectiveness of aspirin, but also serves as a strong predictor of patients who are at risk for heart attack, according to a study appearing July 3, 2013, in the online edition of the Journal of the American College of Cardiology.

“We recognized the concept of aspirin resistance among a population of patients who have cardiac events or stroke,” said senior author Geoffrey S. Ginsburg, M.D., PhD, director of genomic medicine at Duke’s Institute for Genome Sciences & Policy and executive director of the Center for Personalized Medicine. “We give the same dose to all patients, but maybe some patients need a larger dose of aspirin, or maybe they need to try a different therapy entirely. We need better tools to monitor patients and adjust their care accordingly, and the findings from our study move us in that direction.”

The Duke researchers enlisted three groups of participants – two of healthy volunteers and one comprised of patients with heart disease seen in outpatient cardiology practices.

The healthy volunteers were given a dosage of 325 mg of aspirin daily for up to a month; the heart disease patients had been prescribed a low dose of aspirin as part of their treatment. Blood was then analyzed for the impact of aspirin on RNA expression and the function of platelets, which are the blood cells involved in clotting.

The RNA microarray profiling after aspirin administration revealed a set of 60 co-expressed genes that the researchers call the “aspirin response signature,” which consistently correlated with an insufficient platelet response to aspirin therapy among the healthy subjects as well as the heart disease patients.

The researchers also examined the aspirin response signature in another group of patients who had undergone cardiac catheterizations. They found the signature was also effective in identifying those patients who eventually suffered a heart attack or died.

“The aspirin response signature can determine who is at risk for heart attack and death,” said Deepak Voora, M.D., assistant professor of medicine at Duke and lead author of the study. “There is something about the biology of platelets that determines how well we respond to aspirin and we can now capture that with a genomic signature in blood.”

Ginsburg said the research is progressing to recreate the findings in other populations, and to develop a standardized testing system that could one day move the analysis into daily practice.

“Nearly 60 million people take aspirin regularly to reduce their chances of heart attack and death, but it doesn’t work for everyone,” said Rochelle Long, Ph.D., of the National Institutes of Health’s National Institute of General Medical Sciences, which partly supported the study. “By monitoring gene activity patterns these investigators uncovered a ‘signature’ linked to inadequate responsiveness. This work may eventually lead to a simple blood test to identify those who do not benefit from aspirin, enabling them to seek other therapeutic options.”

In addition to Ginsburg and Voora, study authors include Derek Cyr; Joseph Lucas; Jen-Tsan Chi; Jennifer Dungan; Timothy A. McCaffrey; Richard Katz; L. Kristin Newby; William E. Kraus; Richard C. Becker; and Thomas L. Ortel.

The study received funding from the Duke Institute for Genome Sciences & Policy; the National Institutes of Health (T32HL007101 to DV); the National Center for Research Resources (UL1RR024128); the National Institutes of General Medical Sciences (RC1GM091083); the Centers for Disease Control and Prevention (5U01DD000014); and the David H. Murdock Research Institute.

Study: Aspirin Exposure Reveals Novel Genes Associated with Platelet Function and Cardiovascular Events

Source: Duke Medicine

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