CARDIOCORE and ROCHE Join Forces to Contribute Unique Data to the URMC/FDA Holter ECG Warehouse

THEW, Roche and Cardiocore Collaboration Enables Key Cardiac Safety Research Milestone

Washington, DC – 09.December.2009 — The Telemetric and Holter ECG Warehouse (THEW) is a cardiac research initiative developed by the University of Rochester Medical Center (URMC) in partnership with the Food and Drug Administration (FDA). Today, THEW administrators announced that Roche shared data from a recently completed Thorough QT study (TQT), with Cardiocore being the first core lab to successfully format Holter ECG data for upload to the THEW repository.

As part of their continuing collaboration with Roche, Cardiocore acquired and analyzed the data during a 2008 TQT. To prepare the continuous electrocardiographic recordings for THEW submission, Cardiocore administered Roche’s custom specification for data de-identification.

“We are delighted to contribute these data to the THEW program,” said Ignacio Rodriguez, MD, head of Roche’s ECG Working Group. He continued, “We hope that this data will help advance the science of cardiac safety monitoring. In striving for innovation, we are fortunate to work with like-minded and supportive partners at the THEW and Cardiocore.”

In this Roche TQT, Cardiocore analyzed more than 300 recordings of 24-hour Holter data that were acquired from 76 subjects in a crossover design. Cardiocore deployed high-fidelity devices that record continuous electrocardiographic data at 1,000 samples per second, enabling true one-millisecond resolution during analysis. Fully de-identified data from the placebo and positive control periods were shared.

The THEW director, Dr. Jean-Philippe Couderc, PhD commented, “Roche has shared, with the help of Cardiocore, a scientifically relevant set of information. Their successful submission of both clinical and ECG information to our international repository solidifies our legal framework for data sharing. More importantly, this data will enable unique research projects for validating and improving precision of current and future ECG technologies. THEW partners will be able to access these Holter ECGs from which more than 2 million standard 12-lead ECG tracings can be extracted. We are glad to recognize both Roche and Cardiocore as pioneering data contributors to our initiative.”