Critical Diagnostics


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about us

The world is changing all around us. Healthcare is constantly changing and evolving, as new and better ways of providing patient care are helping to save lives and improve the quality of life for those in need. Critical Diagnostics is a company on the cutting edge of this change, focused on the discovery, development, and commercialization of novel biomarkers in cardiovascular diseases.

Our lead product, the Presage® ST2 Assay, has received FDA clearance and is CE Marked in Europe. This simple, non-invasive test measures for soluble ST2 in the blood, which can aid physicians in risk assessment of heart failure patients.

Soluble ST2 has now been published in more than 100 peer-reviewed articles and scientific posters studying more than 36,000 patients. These clinical studies have demonstrated that high levels of soluble ST2 are predictive of adverse patient outcomes and death in a broad spectrum of cardiovascular disease. They have further shown that the prognostic information from soluble ST2 is independent and provides added information to the cardiac biomarkers commonly used today, including the natriuretic peptides, BNP and NT-proBNP.

Critical Diagnostics was founded in 2004. The Company licensed intellectual property discovered in 2002 at Brigham and Women's Hospital relating to ST2, for which it now holds the exclusive worldwide rights. The company has since expanded its intellectual property portfolio and holds several issued patents in the US and abroad as well as numerous patents pending.

Critical Diagnostics is a privately-held company.

our mission statement

To build shareholder value by delivering healthcare solutions that save and improve patients’ lives, and to do that in cost effective ways. We will realize this mission by focusing on quality: setting the highest standards in the products we produce, the service we provide, and the care we put into everything we do.