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Critical Diagnostics Launches Rapid Test for Managing Heart Failure Patients

SAN DIEGO, CA March 10, 2015 - Critical Diagnostics announced today it has expanded its cardiac biomarker testing product portfolio by CE marking the Aspect-PLUS™ ST2 test, the world’s first and only rapid quantitative ST2 test. Results are reported in under 30 minutes.

The Aspect-PLUS™ ST2 test can aid clinicians in assessing risk, making treatment decisions, evaluating therapy effectiveness, and monitoring patient care.

The Aspect-PLUS test is not currently available for sale in the United States.

The Aspect-PLUS ST2 test is ideal for hospital and independent laboratories. The test is performed by depositing a plasma sample and reagent on a small, single-use Aspect-PLUS cartridge, which is then placed in the shoebox-sized Aspect READER. There’s nothing else for the operator to do. The entire analytical phase of the process is automated.

“As highlighted by the growing health and economic burden of heart failure globally, it is clear that the widespread availability of novel clinical tools that immediately and effectively impact outcomes is needed,” remarks David Geliebter, CEO of Critical Diagnostics. “We’re committed to this pursuit and the Aspect-PLUS ST2 test is proof of that.”

A recently published European-based study[1] demonstrated ST2 values accurately predict heart failure event risk. Levels of ST2 were measured at presentation to the emergency department and after 48 hours in 207 patients with acute heart failure. In univariate analysis the percentage change of ST2 over the first 48 hours significantly predicted long-term mortality.

In multivariable analysis, the predictive potential of early ST2 changes persisted after the adjustment for ADHERE risk factors (blood urea nitrogen, systolic blood-pressure and serum creatinine), traditional markers of inflammation (total white cell count and high- sensitive C-reactive protein), BNP, troponin T, percentage BNP changes during the first 48 hours as well as the cumulative diuretic dose administered during the first 48 hours.

“This study clearly showed that the change in ST2 values over the first 48 hours of acute heart failure hospitalization reflect the patients’ prognosis and response to therapy,” noted James Snider, Ph.D., President of Critical Diagnostics. “One of the most interesting findings was that higher risk patients—those whose ST2 didn’t drop by 20% or more over this 48-hour window—but who received more intensive outpatient care did as well as patients whose ST2 levels did decrease by more than 20%, demonstrating that risk can be attenuated.”

In a recently-published review article,[2] authors Dr. Antoni Bayes-Genis of Hospital Universitari Germans Trias i Pujol, Barcelona and Dr. Lori Daniels of University of California, noted, “ST2 is an assay that has come of age and is now a clinically useful tool for risk stratification of patients with acute and chronic HF (heart failure), as well as patients at risk for HF. The information gleaned from ST2 levels is complementary to that obtained from NPs (natriuretic peptides).

“Because elevated ST2 levels are so closely related to risk of adverse outcomes including short-term hospital readmission, they have immediate clinical implications for providers. Identifying at-risk patients, either prior to hospital discharge or in an ambulatory clinic setting, can help providers preferentially focus attention and resources there, where they are most needed.”

In another recently published paper (“Biomarker-assist score for reverse remodeling prediction in heart failure: The ST2-R2 score,” Josep Lupon et al, International Journal of Cardiology 184 [2015] 337–343), ST2, in conjunction with five clinical variables[3], was able to predict reverse remodeling. Remodeling refers to the changes in size, shape, structure and physiology of the heart after injury to the myocardium. Understanding the components of this process with the goal of stopping or reversing its progression is often termed 'reverse remodeling.'

In this just over 300-person, multicenter study several biomarkers including Critical Diagnostics’s ST2, NT-proBNP, high-sensitive troponin, both from Roche (OTC:RHHBY), and Galectin-3 (NASDAQ: BGMD), were evaluated to determine if any added to the ability to predict reverse remodeling over clinical variables alone. In a rigorous multivariate analysis, only ST2 survived and was statistically independently associated with reverse remodeling, reclassifying some 15% of patients over the clinical model alone. Patients in the study with reverse remodeling had a 3-fold lower incidence of clinical events, defined as cardiovascular death of heart failure hospitalization over the one year follow up.

The Aspect-PLUS ST2 test is available through Critical Diagnostics’ extensive network of exclusive European distribution partners, including (in alphabetical order) Assut-Europe (Italy/Belarus), Bestbion (Germany/Austria), Cruinn (Ireland), Eurobio (France), Genloxa (Poland), INyDIA (Spain/Portugal), IVD Bulgaria (Bulgaria), Life Biomedical (UK), Maritim (Croatia/Slovenia), Nordic Diagnostica (Sweden), Ruwag Diagnostics (Switzerland), and Sopachem (Benelux).

The Aspect-PLUS ST2 test will be on display at the upcoming European Society of Cardiology (ESC) Heart Failure 2015 Congress in Seville, Spain in late May.

About Heart Failure
Heart failure is a condition in which the heart can't pump enough blood to meet the body's needs. As noted by Professor Eugene Braunwald in “The War Against Heart Failure,” in The Lancet,[4] Heart failure is a global problem with an estimated prevalence of 38 million patients worldwide, and a number that is increasing with the aging of the population. Heart failure is the most common diagnosis in patients aged 65 years or older admitted to hospital. Despite some progress, the prognosis of heart failure is worse than that of most cancers.

About ST2
ST2 is a soluble protein expressed by the heart in response to disease or injury. It is reflective of ventricular remodeling and cardiac fibrosis associated with heart failure. 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. Since 2013 there have been over 400 scientific papers and abstracts published on ST2[5].

About Critical Diagnostics
Critical Diagnostics (www.criticaldiagnostics.com) develops novel biomarkers to help physicians optimize patient care in cardiovascular diseases, while containing healthcare costs. The Aspect-PLUS ST2 test and the Presage® ST2 Assay from Critical Diagnostics are the only commercially available ST2 biomarker tests 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. The Aspect-PLUS ST2 test is CE Marked.

For More Information, Contact:
Dennis Dalangin, VP Marketing
Telephone: +1 (877) 700-1250
Email: ddalangin@criticaldiagnostics.com

[1] “Heart Failure Therapy Induced Early ST2 Changes May Offer Long-term Therapy Guidance,” Journal of Cardiac Failure, 2013.
[2] “Using ST2 in cardiovascular patients: a review,” Future Cardiology, 2014.
[3] Age, non-ischemic etiology of HF, NYHA functional class, baseline LVEF, absence of left bundle branch block.
[4] Published online November 16, 2014
[5] Based on PubMed.com listings.