Cardiocore Leads Core Lab Industry with Advanced Holter Bin Methodology

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Modern Approach Reduces Sponsors' Potential for False-Positive QT Results

Cardiocore, a premier centralized cardiac testing lab, announced today that it has accomplished significant advancements in the Holter Bin Methodology for ECG data analysis. Cardiocore's technology and processes isolate heart rate-related QT effects, thereby reducing the potential for false positive outcomes in Thorough QT studies. Cardiocore Chief Medical Officer, Lawrence Satin, MD, FACC has been invited to discuss these developments at the FDA's Cardiovascular Safety, QT, and Arrhythmia in Drug Development conference, on April 29-30, in Bethesda, Maryland.

Dr. Satin's presentation will demonstrate how the Holter Bin method highlights distinctions between various causes of QT prolongation. This enhanced level of QT analysis may be extraordinarily valuable to many Thorough QT study sponsors.

"We are very proud to provide our clients this advanced scientific service in their cardiac safety trials," said Cardiocore Chief Medical Officer, Lawrence Satin, MD, FACC. He continued, "Particularly for drug developers who's compound may affect heart rate, this methodology provides a clearer and more complete foundation to establish their drug's safety profile."

Cardiocore Vice President of Medical Operations, Polina Voloshko, MD added, "To properly apply the Holter Bin technique, important intricacies such as time-matching and hysteresis management must be addressed. Cardiocore has resolved these issues by deploying sophisticated technologies and by applying a full understanding of the test drug's pharmacokinetic profile into the protocol design." In support of Cardiocore's Holter Bin service, well-known cardiac testing technology provider, AMPS, has customized its newly upgraded WinAtrec application for seamless integration into Cardiocore's advanced cardiac data management platform.

As a secondary endpoint in a Thorough QT study, this Holter Bin solution complements the mathematical formulas traditionally used to mitigate the affect of heart rate variability on QT analysis. Heart beats are organized into "bins" of similar heart rate. Measurements from one beat are compared to those from other beats within the same bin. The resulting data distinguishes potentially fatal forms of QT prolongation--those caused by ion channel blockade--from less-troubling types of QT prolongation caused by heart rate fluctuation.

More information about Cardiocore's scientific expertise, data management system, and sponsor-benefiting Holter solutions are available at the company's web site, http://www.cardiocore.com.

About Cardiocore: Cardiocore has provided superior centralized cardiac testing services to the pharmaceutical industry for 17 years. Services include centralized electrocardiography (ECG), Holter monitoring, echocardiography (ECHO), multigated acquisition scans (MUGA), protocol development and statistical analysis. The company is experienced in cardiac safety and efficacy testing in Phase I-IV and Thorough QT clinical trials. These services are supported by the company's advanced data management system featuring the proprietary HolterGatewayâ„¢ and CardioPortalâ„¢. Cardiocore's U.S. headquarters is located in Bethesda, Maryland, its West Coast office is located in San Francisco, California, and its European subsidiary, Cardiocore Limited, is located in London, England. http://www.cardiocore.com.

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