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Tethys Bioscience Presents Clinical Data Of PreDx Diabetes Risk Score At ADA Scientific Sessions

Tethys Bioscience, Inc. announced the presentation of new data supporting the cost-effectiveness and clinical utility of its flagship product, the PreDx Diabetes Risk Score, at the American Diabetes Association's 69th Annual Scientific Sessions.

The PreDx Diabetes Risk Score (DRS) is a first-of-its-kind risk-assessment tool that delivers an assessment of an individual’s risk of developing type 2 diabetes within five years, This PreDx DRS, along with other clinical information, may assist physicians to target prevention efforts to patients at greatest risk. Data from two separate presentations help to demonstrate the clinical and economic utility of the test, confirming its ability to assess diabetes risk in a new, previously unstudied population and demonstrating that a model of a diabetes prevention program using the test represents a cost-effective means of assessing diabetes risk according to standard measures.

The data presented at ADA add to the mounting body of evidence in support of the utility of the PreDx Diabetes Risk Score, said Mickey Urdea, Tethys’ chairman and chief executive officer. By arming physicians and patients with tools to accurately gauge risk of diabetes and take action to prevent or delay it, we may be able to reduce the enormous health and economic toll of this growing epidemic.

Data presented were as follows: Health Economic Rationale for PreDx Diabetes Risk Score: Sean D. Sullivan, PhD, a professor in the departments of Pharmacy and Health Services at the University of Washington and director of the university’s Pharmaceutical Outcomes Research and Policy Program, delivered an oral presentation on the long-term cost-effectiveness of a diabetes prevention program employing the PreDx Diabetes Risk Score. Sullivan and colleagues modeled three scenarios for stratifying a cohort of patients (mean age 55, BMI >25) according to their risk of developing type 2 diabetes: use of the PreDx DRS, usage of fasting plasma glucose testing, and average clinical practice (fasting plasma glucose testing, 20% compliance). In each scenario in the model, patients identified as high-risk received metformin therapy. The model indicated that the risk-stratification strategy employing PreDx with intervention in high-risk patients reduced mortality, improved quality of life, and reduced the overall cost of preventing diabetes. The strategy was found to be cost effective (cost per quality adjusted life year of less than $50,000) over a 10-year time horizon, and with potential for cost-savings at a 15+ year time horizon. Additionally, the model indicated that the PreDx DRS strategy prevented, over ten years, almost 120 cases of diabetes per 1000 high-risk patients, versus less than 60 cases for fasting plasma glucose and less than 20 for average clinical practice.

Long-term diabetes disease management is a costly proposition, both in terms of its effects on the patient and the healthcare system at large, said Dr. Sullivan. As diabetes’ prevalence grows, it will be critically important to develop new, cost-effective methods of anticipating the disease. Our research indicates that using the PreDx Diabetes Risk Score to help stratify patients according to their risk is cost-effective in a ten-year horizon, and perhaps even cost-saving over a lifetime, making it an important consideration as we collectively work to stave off what is rapidly becoming a global epidemic of chronic disease.

Exciting Development Data on a Diabetes Risk Assessment Tool: Tethys researchers, along with those of leading Danish and Swedish universities, presented data on the continued development of a Diabetes risk assessment tool. The data supports a risk assessment approach in a new population. In a poster at the meeting, researchers detailed their work in the Botnia cohort, a Finnish family-based study of 1,968 subjects, demonstrating that a risk assessment score could be generalized beyond the population in which it was developed (the Inter99 study, a Danish longitudinal population-based study). Furthermore, the performance of the risk tool in the Botnia cohort was superior to other tests typically used for type 2 diabetes risk assessment, including fasting plasma glucose, oral glucose tolerance, and other diabetes screening methods.