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December 01, 2015 11:22 PM ET

Healthcare Providers and Services

Company Overview of Critical Care Diagnostics Inc.

Company Overview

Critical Care Diagnostics, Inc. develops laboratory assays for the cardiovascular diseases. It offers Presage, a laboratory assay employing ST2 for the diagnosis and prognosis of cardiovascular disease. The company also offers Aspect-PLUS ST2 test, a cardiac biomarker testing product that aids clinicians in assessing risk, making treatment decisions, evaluating therapy effectiveness, and monitoring patient care. Critical Diagnostics was incorporated in 2004 and is based in New York, New York.

802 6th Avenue

Suite 63

New York, NY 10001

United States

Founded in 2004





Key Executives for Critical Care Diagnostics Inc.

Founder, Chairman, Chairman of the Management Board and Chief Executive Officer
President and Member of the Management Board
Vice President of Operations & Global Marketing
Senior Vice President of International Sales and Business
Senior Vice President of Sales & Business Development
Compensation as of Fiscal Year 2015.

Critical Care Diagnostics Inc. Key Developments

China Food and Drug Administration Clears Critical Diagnostics's Presage ST2 Assay for Clinical Use

Critical Diagnostics announced that the China Food and Drug Administration (CFDA) has cleared the Presage ST2 Assay for clinical use. This follows news that ST2 has been included in the coveted Chinese Heart Failure Guidelines. In a rigorous multivariate analysis involving over 1,500 Chinese heart failure patients, those with the high levels of ST2 were at over 5 times the risk for all-cause death or cardiac transplantation within 30 days, in comparison to patients with the lowest ST2 levels. Moreover, ST2 levels were significantly elevated among patients with adverse events across all time periods examined over a 3-year follow up period. ST2 is a soluble protein expressed by the heart in response to disease or injury. It is reflective of ventricular remodeling and cardiac fibrosis associated with heart failure. ST2 is not adversely affected by confounding factors such as age, body mass index and impaired renal function. Unlike many other cardiac biomarkers, ST2 levels change quickly in response to changes in the patient’s condition—thus helping physicians make informed decisions on an appropriate course of action to take and, if needed, to quickly adjust care.

Critical Diagnostics Launches Aspect-PLUS ST2 test

Critical Diagnostics announced it has expanded its cardiac biomarker testing product portfolio by CE marking the Aspect-PLUS ST2 test. Results are reported in under 30 minutes. The Aspect-PLUS ST2 test can aid clinicians in assessing risk, making treatment decisions, evaluating therapy effectiveness, and monitoring patient care. The Aspect-PLUS ST2 test is ideal for hospital and independent laboratories. The test is performed by depositing a plasma sample and reagent on a small, single-use Aspect-PLUS cartridge, which is then placed in the shoebox-sized Aspect READER. There’s nothing else for the operator to do. The entire analytical phase of the process is automated.

Critical Diagnostics Announces Results of Massachusetts General Hospital Biomarker-Guided Therapy Study of Chronic Heart Failure Patients

Critical Diagnostics announced that results of a Massachusetts General Hospital biomarker-guided therapy study of chronic heart failure patients with left ventricular systolic dysfunction followed over a 10-month period just published in the Journal of the American College of Cardiology's JACC: Heart Failure, demonstrated that of all biomarkers evaluated, only serial testing of ST2 enhanced prognostic information over baseline concentrations and predicted change in left ventricular function. As a baseline value added to traditional clinical and biochemical characteristics including NT-proBNP, ST2 added independent information in predicting total cardiovascular events, but, more importantly, as a serial biomarker measured every three months during the treatment period of the study, only ST2 provided incremental prognostic information. Specifically, patients with persistently elevated ST2 levels were at more than three-and-a-half times the risk of experiencing a cardiovascular event, such as an unplanned hospitalization, than patients who had low ST2 levels. Furthermore, this study also shows there was a direct relationship between the percent of time spent with ST2 below its FDA-cleared threshold of 35 ng/mL and cardiovascular event rates. The time that patients spent with ST2 levels below 35 ng/mL was directly related to improving cardiac function as measured by decreasing left ventricular end diastolic volume index, even after adjusting for relevant baseline characteristics. These findings strongly suggest that managing patients to a ST2 level below 35 ng/mL may be an appropriate patient management strategy, versus managing patients to a specific dosing regimen. Moreover, study further shows change in beta blocker dose in heart failure patients was directly associated with a change in subsequent levels of ST2. The findings reiterate those of another paper from this study just published that show that patients above 35 ng/mL who were taking low doses of beta blocker were almost seven times as likely to experience a cardiovascular event, such as an unplanned hospitalization, than patients who had low ST2 levels and were on high-doses of beta blocker.

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