Critical diagnosis receives CE Mark for Presage (R) Assay ST2
Critical diagnosis has announced that it has received CE (CONFORMITY enemies Europ) Mark for its high sensitivity Presage ST2 analysis and effective marketing in Europe. The product is indicated for use as an aid to risk stratification of patients with acute coronary syndrome e. This regulatory step is the first time that a test has become commercially available for clinical measurement of biomarkers soluble ST2.“Presage ST2 allows me to predict which patients with heart failure and dyspnea are most at risk of hospital readmission and serious adverse events, including death. In helping me to risk stratify my patients, I can better allocate time and resources for patients need it most and offer a higher level of general attention to all my patients, “said Dr. Christian Mueller, a cardiologist at the University Hospital of Basel, Switzerland. “Finally having a commercial test for ST2 means this important prognostic tool can now be widely distributed to medical professionals.”
CE marking is the latest in a series of milestones for the diagnosis
“EC is further validation of our unique Presage ST2 Assay, and comes after extensive clinical trials. The high sensitivity measurements of ST2 enabled for our tests have always shown to provide new prognostic information to physicians on the future health of their patients’ cardiovascular providing an overview of the biology of disease processes and fibrotic novel cardioprotective there are no other cardiovascular biomarkers, “said Pat Arensdorf, CEO of critical diagnosis.” We are pleased that doctors hope the European ST2 essay hours to optimize their care for this important group and increasing high-risk patients. Furthermore, it is our hope that better risk stratification tools, physicians can more effectively manage medical resources for these patients and significantly reduce the overall costs of health care. ”
The Omen ST2 test is not available for sale in the U.S., pending FDA approval. The Omen ST2 test is CE marked.
The company has sold the intellectual property, discovered in 2002 at Brigham and Women Hospital for ST2, a biomarker protein that helps a medical risk stratify patients with heart failure and other diseases. This intellectual property has since been described in documents filed several patents and two U.S. patents have already issued (U.S. Patent Numbers 7,655,415 and 7,432,060). Diagnosis has produced a critical essay hope ST2, providing a highly sensitive assay to quantitatively measure ST2.
The use of ST2 as a tool for risk stratification has been studied to date in over 20,000 patients and presented more than thirty peer-reviewed papers and publications.
Research groups have demonstrated that ST2 has prognostic value that adds new information beyond that provided by other biomarkers such as BNP or NT-proBNP for heart failure and patients with acute coronary syndrome, with implications promise for improving the care of patients.
