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SAN DIEGO, CA January 12, 2015 – Critical Diagnostics reported today that the U.S. Center for Medicare and Medicaid Services (CMS) has confirmed that the 2015 Medicare reimbursement for performing a ST2 test will be $29.93[1]. This took effect January 1, 2015. At the same time, a new Current Procedural Terminology (CPT) code[2] (83006) was issued by the American Medical Association through the CPT Editorial Panel, to allow for the communication of uniform information about ST2 testing.

These favorable decisions follow notice of acceptance by The American Journal of Cardiology of a comprehensive consensus paper on ST2 that will appear as a print supplement. The paper grew out of a meeting of prominent leaders in the field of cardiology gathered earlier in 2014 to discuss the evidence base behind the evolving role of the cardiac biomarker ST2 in the management of patients with heart failure and related cardiac diseases.

Authors on the paper include (in alphabetical order) Ednan Bajwa, MD, Massachusetts General Hospital, Boston, MA; Antoni Bayes-Genis, MD, PhD, Hospital Universitari Germans Trias I Pujol, Barcelona, Spain; Lori Daniels, MD, MPH, University of California, San Diego, CA; Christopher deFilippi, MD, University of Maryland, Baltimore, MD;  Salvatore Di Somma, MD, PhD, Sant’Andrea Hospital, Rome, Italy; Jennifer Ho, MD, Boston Medical Center, Boston, MA; Allan Jaffe, MD, PhD Mayo, Rochester, MN; James L. Januzzi, Jr, MD, Massachusetts General Hospital, Boston, MA; Bonnie Ky, MD, MSCE, Assistant Professor of Medicine at the Hospital of the University of Pennsylvania; Alan S. Maisel, MD, University of California, San Diego, CA; Alexandre Mebazaa, MD, PhD, Hospital Lariboisiere, Paris, France; Thomas Mueller, MD, Konventhospital Bamherzige Bruder Linz, Linz, Austria; Prof. Christian Müller, Department of Cardiology Head of Outcome Research, University Hospital Basel; Domingo Pascual-Figal, MD, PhD, University Hospital Virgen de la Arrixaca, Murcia, Spain; A. Mark Richards, MD, PhD, Christchurch School of Medicine, Christchurch, New Zealand; Piyamitr Sritara, MD, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Thomas Wang, MD, MPH; Vanderbilt University, Nashville, TN; and Yuhui Zhang, MD, Fuwai Hospital, Beijing, China.

“The recent decisions by CMS, the AMA and the soon-to-be-published ST2 consensus paper are all testament to the ever-expanded body of evidence supporting ST2’s clinical utility in helping physicians better manage heart failure patients,” comments David Geliebter, CEO, Critical Diagnostics.

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[3]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.

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 care.

The Presage® ST2 Assay from Critical Diagnostics is the only commercially available ST2 biomarker test 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.

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 some 50 countries, covering two-thirds of the world’s population.

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

[1] This reflects reductions in the Clinical Laboratory Fee Schedule of -0.25%, as required by law. This rate is the National Limitation Amount. Local rates may vary.
[2] CPT Code is a copyright of the AMA.
[3] Published online November 16, 2014