Critical Diagnostics' high sensitivity Presage ST2 Assay receives CE Mark approval

Critical Diagnostics announced today that it has received CE (Conformité Européenne) Mark for its high sensitivity Presage ST2 Assay and is commencing commercialization in Europe. The product is indicated for use as an aid in risk stratification of patients with heart failure or acute coronary syndrome. This regulatory milestone marks the first time that an assay has become commercially available for the clinical measurement of the biomarker soluble ST2.

“Finally having a commercial assay for ST2 means this important prognostic tool can now be made widely available to medical professionals.”

"Presage ST2 allows me to predict which heart failure and dyspneic patients are at highest risk of hospital readmission and serious adverse events, including death. By helping me risk-stratify my patients, I can better allocate time and resources to the patients who need them most and provide a higher overall level of care for all of my patients," said Dr. Christian Mueller, cardiologist at the University Hospital Basel, Switzerland. "Finally having a commercial assay for ST2 means this important prognostic tool can now be made widely available to medical professionals."

"CE Mark is a further validation of our unique Presage ST2 Assay, and comes after extensive clinical studies. The high sensitivity measurements of ST2 enabled by our assay have been consistently proven to provide new prognostic information to clinicians on the future health status of their cardiovascular patients, providing insight into novel biology regarding fibrotic and cardioprotective disease processes not available from other cardiovascular biomarkers" said Pat Arensdorf, Chief Executive Officer of Critical Diagnostics. "We are pleased that the Presage ST2 Assay will now help European physicians optimize their care for this large and growing group of high-risk patients. Furthermore, it is our hope that with better risk stratification tools, physicians can more efficiently manage medical resources required by these important patients and reduce overall health care system costs."

The use of ST2 as a risk stratification tool has been studied to date in more than 20,000 patients and presented in over thirty peer-reviewed papers and publications. Leading research groups have demonstrated that ST2 has prognostic value that adds new information over and above that provided by other biomarkers, such as BNP or NT-proBNP, for Heart Failure and Acute Coronary Syndrome patients, with promising implications for improvements in patient care.

CE Mark is Latest in Series of Key Milestones for Critical Diagnostics

Critical Diagnostics was founded in 2004 to develop and commercialize innovative new diagnostic tools for life-threatening diseases. The Company licensed intellectual property discovered in 2002 at Brigham and Women's Hospital relating to ST2, a protein biomarker that helps a physician risk stratify patients with heart failure and other diseases. This intellectual property has since been described in numerous patent filings, and two US patents have already issued (US patent numbers 7,655,415 and 7,432,060). Critical Diagnostics has produced the Presage ST2 Assay, providing a highly sensitive assay to quantitatively measure ST2.