Tethys and the United States Air Force Collaborate on a Clinical Trial to Assess Motivational Impact of the PreDx® Diabetes Risk Score on Positive Behavioral Change
EMERYVILLE, Calif.-- March 23, 2011 --Tethys Bioscience, Inc., a privately held cardiometabolic diagnostics company, and the United States Air Force have established a collaboration to study the impact of the PreDx® Diabetes Risk Score on behavioral change, the key component in reducing the incidence of type 2 diabetes, among the Air Force’s retirees and dependents. Type 2 diabetes is a serious, costly and growing healthcare risk within the military’s large retiree population. Diabetes can be prevented, however, with improvements in lifestyle, including diet, nutrition and exercise. A common obstacle to lifestyle changes is lack of compliance among at-risk individuals.
To evaluate the impact of a more accurate assessment of type 2 diabetes risk on compliance with a lifestyle modification program, the Air Force is conducting a clinical study utilizing Tethys’ PreDx® Diabetes Risk Score (DRS), a simple-to-use, multimarker blood test designed to determine an individual’s personalized risk of diabetes conversion within five years. The study will assess the correlation between receiving comprehensive and individualized information about disease risk and the motivation to adopt a healthier lifestyle.
Mark W. True, MD, Lieutenant Colonel, US Air Force, Medical Corps, of the Endocrinology Service at Wilford Hall Medical Center, is the principal investigator for the study.
“We hope to determine whether improved knowledge of an individual’s risk for diabetes impacts that patient’s motivation to comply with lifestyle recommendations,” said Dr. True. “We also believe this study could contribute to the medical community’s efforts to target patients at the highest risk of disease. We need to be smart about how to best use limited resources in our attempts to reverse the type 2 diabetes epidemic in the US.”
“Our collaboration with the US Air Force provides an optimal setting in which to prospectively demonstrate the value of PreDx DRS in enabling physicians and patients to determine what behavioral and dietary changes can be most effective in preempting disease in high risk individuals,” said Mickey S. Urdea, PhD, chairman and chief executive officer of Tethys. “With the CDC estimating as many as 79 million prediabetic people in the US, our medical system urgently needs better tools to stratify and identify the small percentage of those at most imminent risk who will benefit from intervention. PreDx DRS is that tool, and we look forward to the results of this important study.”
The two-arm, randomized trial will enroll 600 pre-diabetic subjects at six Air Force bases in the US. All subjects will participate in a 12-week “Group Lifestyle Balance Program.” This program is based on the Diabetes Prevention Program (DPP), a major clinical trial which found that participants who lost a modest amount of weight through dietary changes and increased physical activity significantly reduced their chances of developing diabetes. All subjects will be administered the PreDx DRS test at the beginning and end of the study period. Half the study population (the intervention group) will be given the results of their PreDx DRS test before they start the Group Lifestyle Balance Program and will know their specific risk profile; the other half (the control group) will not see their results. Study participants will be assessed after 12 weeks and at 6 months relative to specific endpoints, including weight loss, waist circumference, frequency of class attendance and completion of class assignments.
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.
About PreDx® Diabetes Risk Score
The PreDx Diabetes Risk Score (DRS) provides enhanced risk stratification through the measurement of multiple biomarkers linked to pathways of diabetes progression. PreDx DRS was developed using a unique approach to quantifying biomarkers suspected of playing roles in diabetes development. Tethys methodology enabled evaluation of many biomarkers utilizing very small amounts of blood from select and well-characterized large study cohorts with known diabetes outcomes. The company then determined the combination of these biomarkers with an algorithm that best identified an individual’s risk of developing type 2 diabetes within five years. PreDx DRS has been validated by the Tethys Clinical Laboratory (TCL) in several large populations. The test uses standard immunoassay and clinical chemistry formats, sample collection and shipment methods. Currently performed exclusively by the CLIA-certified TCL, the test generates a Diabetes Risk Score between 1 and 10 that corresponds to an absolute percentage risk of developing disease within five years.
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 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.