< back to press releases

Critical Diagnostics’ Presage® ST2 Assay Cardiac Biomarker Test Receives China Food and Drug Administration Clearance

SAN DIEGO, CA March 24, 2015 – Critical Diagnostics announced today that the China Food and Drug Administration (CFDA) has cleared the Presage ST2 Assay for clinical use. This follows news that ST2 has been included in the coveted Chinese Heart Failure Guidelines.

In March 2012 Critical Diagnostics appointed Everbest International as its exclusive distributor for the Presage ST2 Assay in the People's Republic of China, Taiwan, Hong Kong and Macau. Since then Critical Diagnostics and Everbest International have been working closely on CFDA clearance and inclusion in the guidelines.

"We are delighted the CFDA has cleared the Presage ST2 Assay for clinical use,” comments David Geliebter, CEO of Critical Diagnostics. “This approval is a key milestone in allowing access the large and fast-growing Chinese diagnostic market.”

“The introduction of ST2 in China will benefit the millions of patients diagnosed with heart failure,” remarked Albert Chen, CEO, Everbest International. “We’ve been looking forward to this day for some time. ST2 is going to change the way heart failure patients are care for and we are proud to be a part of that.”

An estimated 12.5 million people in China are living with heart failure.[1] As a recently published study[2] demonstrated, “ST2 is strong independent risk predictor in Chinese patients hospitalized with HF (heart failure) and provided improved discrimination and reclassification over NT-proBNP[3] in risk prediction.”

In a rigorous multivariate analysis involving over 1,500 Chinese heart failure patients, those with the highest levels of ST2 were at over 5 times the risk for all-cause death or cardiac transplantation within 30 days, in comparison to patients with the lowest ST2 levels. Moreover, ST2 levels were significantly elevated among patients with adverse events across all time periods examined over a 3-year follow up period.

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 care. Since 2013 there have been over 400 scientific papers and abstracts published on ST2[4].

About Critical Diagnostics
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.

For More Information, Contact:
Dennis Dalangin, VP Marketing

Telephone: +1 (877) 700-1250
Email: ddalangin@criticaldiagnostics.com

[1] “Chronic Heart Failure Opportunities for a Bridge Between China and the United States,” Yingnan Bai, Piero Anversa, and Junbo Ge, Circ Res. 2013, which states the prevalence rate to be 0.9% (based on a 2000 study). With a population of 1,398,503, that amounts to over 12.5 million people.
[2] “The Prognostic Value of Plasma ST2 in Hospitalized Chinese Patients with Heart Failure,” PLOS One, October 2014.
[3] NT-proBNP is a product of Roche Diagnostics, a division of Hoffman-La Roche (OTCQX:RHHBY)
[4] Based on PubMed.com listings.