Critical Diagnostics is a healthcare company dedicated to the development of what we believe will be an important new category of diagnostic tools  -- under the Presage^™ brand -- that we hope will greatly advance the field of cardiovascular medicine. With the aid of the Presage assay, we intend to provide doctors with tools to be able to better diagnose patients, aid in on-going treatment, lessen suffering, and even save lives¹.

A Leading Cause of Hospitalization and Death
Despite advances in healthcare, cardiovascular disease is still one of the leading causes of hospitalization and death.

According to the American Heart Association² (AHA), each year:

• Five million Americans present to the emergency department with chest pain
• Of those five million patients, 1.2 million will have a heart attack
• Over five million Americans (two percent of the U.S.) are living with heart failure
• More than 500,000 additional cases of heart failure are diagnosed
• Greater than 700,000 people die from cardiovascular disease

More effectively diagnosing and treating these diseases would not only save lives and improve patient quality of life, but would potentially result in an overall reduction of healthcare costs incurred to treat these conditions.  The AHA estimates that direct medical costs for heart failure will be $33.2 billion for 2007, including over $14.7 billion for hospitalization alone. Indirect costs for lost productivity and death associated with the disease increase this total by nearly $2 billion.

Challenges in Diagnosing and Treating This Killer Disease
Many times it’s difficult for clinicians to determine an exact diagnosis if a patient presents to the emergency department with suspected heart failure, because patients with other diseases, like pulmonary disease, show similar symptoms. Routine clinical evaluation tools, such as ECG and X-rays, are not accurate enough to make such distinction. Over the past few years, though, several laboratory tests for serum biomarkers have been developed. Biomarkers such as BNP and NT-proBNP provide some assistance to practitioners³. However, as useful as they are, there are still large patient groups where results from these tests are ambiguous or marginally informative, at best⁴.

Moreover, determining the severity of disease in a patient diagnosed with heart failure is critical for the physician to determine the most effective course of therapy. The currently available solutions do not adequately provide this information⁴.

The Emerging Solution Brings Hope To Millions
Now a new and novel biomarker – ST2 – is being investigated to provide additional diagnostic and prognostic value to assist in the management of patients with cardiovascular disease, and the Presage toolkit is being developed to bring rapid and accurate measurement of ST2 to the clinic. Critical Diagnostics is the exclusive developer of the Presage laboratory assays employing ST2 for the diagnosis and prognosis of cardiovascular disease⁵.

¹Presage and assays employing ST2 are not currently approved by the FDA for clinical use and are not available for sale in the US for clinical use.
²American Heart Association. 2007 Heart Disease and Stroke Statistics - 2007 Update.  Available at http://www.americanheart.org.
³BNP and NT-proBNP are FDA approved products available from various vendors.
⁴ACC/AHA 2005 Guideline Update for the Diagnosis and Management of Chronic Heart Failure in the Adult. J. Am.Coll.Cardiol. 2005;46;1116-1143.
⁵Under license from The Brigham and Women’s Hospital in Boston.

* Presage and Advancing Medicine, Saving Lives are trademarks of Critical Diagnostics and are registered with the U.S. Patent and Trademark office.