Short-term lowering of PreDx DRS may reduce risk of developing diabetes

Data presented today from an analysis of samples from the European Diabetes Prevention Study (EDIPS) showed that the PreDx® Diabetes Risk Score (DRS) is lowered by lifestyle intervention, which correlates to a reduction in the risk that patients will develop diabetes over time. The data further showed that patients with the highest DRS, who face the highest risk of diabetes, experienced the greatest benefit from intensive lifestyle intervention. The PreDx DRS is a multi-marker fasting blood test that assesses markers of inflammation, fat cell function, and glucose metabolism, and categorizes individuals as low, moderate, or high risk for diabetes conversion within 5 years. Developed by Tethys, the PreDx DRS has been shown to be more accurate than HbA1c or fasting glucose in predicting incident diabetes. The PreDx DRS test can be used to identify patients at risk for diabetes who are most likely to benefit from intensive lifestyle intervention, to reduce their risk of progressing to diabetes over the long term, and to monitor and potentially improve treatment outcomes.

The study also showed that a subset of individuals with the largest decrease in PreDx DRS at 1 year had the largest decrease in risk over 5 years relative to the control group. This observation provides the opportunity to change the intervention in the near term to increase long-term prevention and is the focus of future studies by the company and its collaborators.

The data were presented by Professor Jaakko Tuomilehto, MD, PhD, University of Helsinki, in a poster titled, "Changes in a Diabetes Risk Score Due to Intensive Lifestyle Intervention in the European Diabetes Prevention Study (EDIPS)," at the 2011 American Diabetes Association 71^st Scientific Sessions, being held in San Diego.

Commented Dr. Tuomilehto: "PreDx DRS can be used to:

• identify those who are most likely to develop diabetes;
• monitor the efficacy of therapeutic interventions through follow-up DRS testing; and
• enable physicians to modify the intervention if a change in the DRS indicates the intervention has not been successful.

For instance, a focus on increased supervised compliance with an intervention program could be warranted. Used in this way, DRS can become a novel and valuable component of a diabetes prevention program."

"These data are one of the first clinical demonstrations that the short-term lowering of PreDx DRS reflects an actual change in the risk of developing diabetes many years later, indicating a meaningful link between a decrease in a patient's risk score and reduced diabetes risk," said Mickey S. Urdea, PhD, chairman and chief scientific officer of Tethys. "Additional studies to elucidate the potential to improve outcomes and offer health economic advantages when PreDx DRS is used broadly in medical practice are clearly needed. Such studies could enhance our ability to stratify patients based on their level of risk to focus precious resources, determine their response to intervention and develop better methods to engage patients in behaviors that can delay or prevent progression to diabetes."