Promising preliminary data show Abbott’s innovative testing platform may identify life-threatening infections faster than current methods

Abbott (NYSE: ABT) today announced initial results that suggest its innovative testing platform, known as IRIDICA (currently in development), produces results consistent with the current standard of care in just hours. Currently, the diagnosis of serious infections, such as sepsis or pneumonia, can often take several days. The data from the RApid Diagnosis of Infections in the CriticAlly IlL (RADICAL) study promises to provide new hope for critically ill patients with infections – and potentially change the way infections are diagnosed around the world.

Principal Investigators for RADICAL retrospectively analyzed samples from more than 180 critically ill patients with suspected severe infections from the United Kingdom, France, Belgium, Poland, Switzerland and Germany, to compare the results of Abbott’s technology to culture, the current standard of care. After reviewing the interim data set, independent physicians on an adjudication panel reported they would have prescribed a different course of treatment in more than 50 percent of the cases evaluated.

“Every minute can count when diagnosing and treating serious infections,” study author Jean-Louis Vincent, M.D., Ph.D., Professor of Intensive Care, Université Libre de Bruxelles and the Head of the Department of Intensive Care, Erasme University Hospital, said. “The interim RADICAL results provide increasing evidence that Abbott’s platform may be used for critically ill patients with infections to quickly identify microorganisms before lab cultures can detect similar results.”

The preliminary study data analysis found the sensitivity of the Abbott technology for blood stream infection and pneumonia assays, which were the primary focus of the study, were 88 percent and 91 percent, respectively, when compared to culture. Just as important, the Abbott technology was able to detect other pathogens that the initial culture missed in many patients. Additionally, the negative predictive values (the probability patients with a negative result do not have an infection) were 98 percent and 97 percent, respectively. This information could enable physicians to more confidently and quickly rule out the source of infection. Although time was not a focus of the study, IRIDICA is being designed to produce results in approximately eight hours versus days.

“Doctors need better tools to diagnose their patients when facing unknown infections, and unfortunately, more than 50 percent of culture tests come back negative, even when infections are believed to exist,” said David J. Ecker, Ph.D., divisional vice president, R&D, and general manager for Abbott’s Ibis Biosciences business. “The RADICAL results suggest IRIDICA will provide rapid results with the sensitivity of culture, but much earlier, allowing physicians to act quickly and effectively to make life-saving decisions.”

The Abbott technology is being designed to identify hundreds of bacteria and candida (fungus) from a direct patient specimen in approximately eight hours. The RADICAL study is expected to be completed in late 2014, and IRIDICA is expected to be available as a CE-marked in vitro diagnostic device in European countries within the next 12 months.