December 26, 2014 10:55 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 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

Phone:

925-399-5035

Fax:

866-715-8009

Key Executives for Critical Care Diagnostics Inc.

President and Member of the Management Board
Senior Vice President of Global Business Development
Senior Vice President of Sales & Business Development
Director of Critical Diagnostics and Member of the Management Board
Compensation as of Fiscal Year 2014.

Critical Care Diagnostics Inc. Key Developments

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.

Critical Diagnostics Elects Richard Dee to its Board of Directors

Critical Diagnostics announced the election of Richard Dee to its Board of Directors. Richard is a Board Director and Senior Vice President at Unilab in Manila, Philippines. He oversees Unilab's regional interests in biotechnology and most recently, diagnostics. Richard's career in Unilab spans over two decades and continues to be focused on ethical medicine business development.

Critical Diagnostics Unveils Aspect-LF ST2 Test

Critical Diagnostics has unveiled its Aspect-LF ST2 test, a point-of-care version of the company's lab-based Presage ST2 assay. Aspect-LF is a disposable cartridge, based on lateral flow technology that uses finger-stick whole blood for qualitatively measuring ST2. Results take approximately twenty minutes, enabling physicians to receive vital information on a patient's heart failure disease status while still in the doctor's office or clinic - which can aid greatly in treatment decisions.

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