SAN DIEGO--(BUSINESS WIRE)--Apr 2, 2013--As recently reported in the Journal of the American College of Cardiology, a Cleveland Clinic pilot study of 41 patients indicated that an experimental breath analysis device may be able to help diagnose patients with heart failure.

In much the same way as a breath test may one day detect heart failure, there is a FDA cleared test on the market now that is changing the way physicians care for the 23 million diagnosed heart failure patients around the world. It’s the ST2 test from Critical Diagnostics.

Numerous published studies have demonstrated that the level of ST2 in blood can best predict heart failure patient outcomes. Measuring ST2 via a simple, non-invasive test allows for the early identification of high-risk chronic heart failure patients for re-hospitalization and mortality versus those at lower risk.

In spite of all the advancements in medicine, over one million Americans end up in hospital for heart failure each year. Worldwide, that number is several fold greater. More alarming is that one in four of these patients will be re-admitted within 30 days of discharge and approximately half will be readmitted within six months. In fact, heart failure is the leading cause of hospital admissions among the elderly, and is responsible for more hospitalizations than all forms of cancer combined.

As studies have proven, chronic heart failure patients with ST2 levels above the standard cutpoint have a three times greater risk of 30-day rehospitalization or mortality 1. Knowing this information, allows physicians to select those patients who require focused, personalized care.

As a white paper report has shown, using ST2 as part of a patient management program can reduce 30-day rehospitalization rates by 17.3% and also reduce 30-day mortality rates by 17.6%. The report is available on the company’s website at

“The ability to diagnosis heart failure patients earlier and more accurately offers promise,” notes James Snider, President of Critical Diagnostics. “The question, then, becomes how do we identify high-risk patients, how do we best treat them, how do we improve the quality of their lives, and at the same time, not overburden the healthcare system? The answer is through better prognosis. This is where ST2 is making a difference.” “Better care for the millions of people that suffer from heart failure is no longer a dream,” says David Geliebter, CEO of Critical Diagnostics. “It’s here today. ST2 is a valuable prognostic tool in assessing patients across all four stages of heart failure, and we’re proud to be in the forefront of the advancements being made in medicine.” About Critical Diagnostics Critical Diagnostics ( ) develops novel biomarkers to help physicians optimize patient care in cardiovascular diseases, while containing healthcare costs. The company’s Presage ST2 Assay is CE Marked and is cleared by the FDA for use in risk stratification of chronic heart failure patients.

1. Ky, F., et al. High Sensitivity ST2 for Prediction of Adverse Outcomes in CHF. (PHFS)