Tethys and Duke Clinical Research Institute Establish PREVAIL Initiative to Improve Care and Reduce Incidence of Type 2 Diabetes
EMERYVILLE, Calif.--March 30, 2011--Tethys Bioscience, Inc. and Duke Clinical Research Institute (DCRI) have established the PREVAIL patient registry, a multi-center, national initiative that will analyze primary care ambulatory practices for risk factor management of patients at high risk of conversion to type 2 diabetes in the US. Data from PREVAIL (PRovision of EVidence-based Therapies Among IndividuaLs at High Risk for Type 2 Diabetes) will provide insight into the challenges faced in diabetes prevention, and may be used by physicians, quality improvement personnel, healthcare administrators and others to optimize practice algorithms and create targeted educational interventions for high-risk patients with the goal of improving therapeutic outcomes and reducing the incidence of type 2 diabetes and associated cardiovascular disease. The objective of PREVAIL is to improve physician use of evidence-based intervention practices that can be effective in preventing type 2 diabetes and associated cardiovascular events.
The Duke Clinical Research Institute is the world’s largest academic clinical research organization (ARO), combining the clinical expertise and academic leadership of a premier teaching hospital with the full-service operational capabilities of a major contract research organization. Tethys is a privately held cardiometabolic diagnostics company that has pioneered development of a simple-to-use, multimarker blood test, PreDx® DRS, designed to determine an individual’s absolute risk of diabetes conversion within five years.
“PREVAIL is a timely initiative designed to assess and improve type 2 diabetes prevention practices. The data will help us understand where we are performing well, and where we need improvements relating to control of risk factors specifically related to diabetes and cardiovascular disease progression,” said Dr. Bimal Shah, Principal Investigator for PREVAIL. “We appreciate physicians who are participating in the PREVAIL initiative, as well as the support of Tethys, as we work together to provide meaningful, evidence-based insights into how to reduce the incidence and prevalence of this disease.”
“Tethys is pleased to collaborate with Duke Clinical Research Institute and medical professionals on the PREVAIL initiative,” said Mickey S. Urdea, PhD, chairman and chief executive officer of Tethys. “We believe that PREVAIL presents an opportunity to demonstrate the need for more specific identification of individuals who are at the highest risk of developing type 2 diabetes so that we can better focus resources on interventions to preempt the growing epidemic of diabetes and other cardiometabolic conditions.”
PREVAIL is being implemented in two phases. Phase 1, currently underway, is collecting retrospective data from a select number of sites for three months. Phase 2 will utilize these data to evaluate education and quality improvement interventions and for expanded data collection that will become the basis for additional clinical programs and publications.
About Type 2 Diabetes
Type 2 diabetes mellitus is a major public health epidemic. According to the United States Centers for Disease Control and Prevention, diabetes affects nearly 26 million people in the United States or 8.3% of the population. Diabetes is the seventh leading cause of mortality in the US, a major cause of heart disease and stroke, and the leading cause of kidney failure, non-traumatic lower-limb amputations and new cases of blindness among adults in the US. The direct and indirect costs of diabetes in the U.S. exceeded $174 billion in 2007, including $58 billion in indirect costs (disability, work loss, premature mortality). Medical expenditures for people with diabetes are more than two times higher than for people without diabetes. Worldwide, in 2000, diabetes affected an estimated 171 million people and this figure is projected to rise to 366 million by 2030, propelled by increases in age, obesity, and urbanization of the world’s population.
In 2005–2008, based on fasting glucose or A1c levels, 35% of US adults aged 20 years or older had prediabetes (50% of those aged 65 years or older). In 2010, it is estimated that 79 million Americans aged 20 years or older had prediabetes. The Diabetes Prevention Program (DPP), a large prevention study of people at high risk for diabetes, showed that lifestyle intervention to lose weight and increase physical activity reduced the development of type 2 diabetes by 58% during a 3-year period. The reduction was even greater, 71%, among adults aged 60 years or older.
Tethys is a cardiometabolic diagnostics company that creates and commercializes breakthrough biomarker-based blood tests that predict imminent disease risk and enable targeted intervention to preempt the onset of chronic conditions such as type 2 diabetes. Tethys introduced its first product -- PreDx® Diabetes Risk Score -- to the market in 2008, and initiated sales in 2009. The test is performed exclusively by the CLIA-certified Tethys Bioscience Clinical Laboratory. The Tethys PreDx DRS platform includes products in development to determine risk for first-time heart attack, osteoporotic fracture and other cardiometabolic diseases with the goal of improving health outcomes and reducing the devastating economic impact that debilitating, preventable diseases have on individuals and society. For more information about Tethys and PreDx DRS, please visit www.tethysbio.com.