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痴 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 expanded in numerous patent filings, and issued patents in the US and abroad (US patent numbers 7,432,060, 7,760,769, 7,655,415 and 7,998,683).

Critical Diagnostics has produced the Presage® ST2 Assay, providing a highly sensitive assay to quantitatively measure ST2. The Presage ST2 Assay has been extensively validated in clinical studies. Critical Diagnostics has attained the CE Mark for the Presage ST2 Assay and plans to commercialize the product in the United States upon receiving FDA clearance.