Cardiac diagnostics firm Critical Care Diagnostics Inc. has landed some new capital as it works with clinical laboratories to make its cardiac biomarker assay, ST2, available to physicians.
The company announced a private placement last month that it said would be used to expand commercialization efforts in the U.S., Europe and Asia Pacific, but did not disclose how much. This week, a regulatory filing revealed that the company has raised $2.6 million from 22 investors. A company executive did not respond to an email for comment.
Critical Care’s product is the Presage ST2 Assay, a lab test that measures the level of a protein called soluble ST2 in the blood to help physicians assess risk in heart failure patients. ST2 is expressed by the heart in response to disease or injury, and unlike other cardiac biomarkers, its concentration in the blood changes quickly in response to a patient’s condition.
In its research, Critical Care has demonstrated that ST2 provides unique information to the cardiac biomarkers commonly used today and that it is useful predictor of adverse patient outcomes in cardiovascular disease. The company positions its test as a way to identify high-risk heart failure patients to help doctors adjust care accordingly and reduce re-hospitalization.
The San Diego company was formed in 2004 with intellectual property licensed from Brigham and Women’s Hospital. Its test is commercially available in kit form and as an immunoassay in reference labs, including Quest Diagnostics and LabCorp, two of the biggest clinical laboratories in the U.S.
But Critical Care received FDA 510(k) clearance in 2011 for and says it has other formats of the test in the pipeline, including a point-of-care test and an automated platform.
The CDC estimates that around 5.7 million people in the U.S. have heart failure. As that number continues to grow, the market for better diagnostic test and therapies is expanding, too. Global Industry Analysts predicts the global market for cardiac biomarkers like ST2, B-type natriuretic peptide and cardiac troponin will reach a value of $3.4 billion by 2017.
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A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
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