PreDx® Diabetes Risk Score (DRS)
Diabetes Overview
Diabetes mellitus is a group of cardiometabolic diseases characterized by excessive levels of blood glucose resulting from impaired insulin production, insulin action, or both. There are two major types of diabetes:1
Type 1 diabetes, previously known as juvenile diabetes, typically appears in early childhood or adolescence. It is believed to result from autoimmune destruction of the beta cells of the pancreas, which renders the body incapable of producing insulin, the hormone needed to regulate blood glucose. Type 1 diabetes is incurable, and requires daily insulin injections.1
Type 2 diabetes is the more common form of the disease, accounting for 90% to 95% of all cases.2 It typically begins as insulin resistance, a disorder in which the body’s cells do not use insulin properly. As the need for insulin rises, the pancreas gradually loses its ability to produce enough of it. Type 2 diabetes can be managed by maintaining a healthy lifestyle and/or with drug therapy. 1 However, despite advances in treatment, type 2 diabetes remains a chronic and incurable disease.
Without ongoing treatment to control abnormally high glucose levels, both type 1 and type 2 diabetes will cause progressive damage to multiple organ systems, leading to debilitating health complications and premature death.1
Type 2 diabetes represents one of the largest pandemics in history.
Over 285 million people worldwide have been diagnosed with type 2 diabetes, with hundreds of millions more at risk of developing the disease.3
Global incidence is projected to reach 438 million by the year 2030.3
As of 2007, in the U.S. alone, a new case of diabetes was diagnosed every 30 seconds (1.6 million new cases per year).4
Diabetes is the 7th leading cause of death in the U.S.1
A staggering 26 million American adults are affected by diabetes, with 79 million more categorized as being at high risk for the disease based on conventional testing.1
Despite the fact that type 2 diabetes is preventable, implementing effective prevention strategies in an at-risk population of 79 million has been impractical and cost-prohibitive
Understanding the economic impact of diabetes.
Diabetes and its life-threatening complications necessitate ongoing and costly treatment, resulting in a disproportionate consumption of healthcare resources. New data drawn from 10 million UnitedHealthcare members indicate that the annual healthcare costs in 2009 for a person with diagnosed diabetes averaged $11,700, over 260% higher than the average of $4,400 for the remainder of the population5. Costs for individuals with diabetes-related complications averaged $20,700 – 470% higher!5
It’s not just the patients and families who must share the financial burden; the costs trickle down to the rest of the population in the form of higher health insurance premiums and reduced disposable income.6 As the prevalence of diabetes continues to rise exponentially, the urgency to better understand the cost-mitigation potential of early and aggressive intervention strategies has never been more vital.
Diabetes is a “silent killer.”
Type 2 diabetes can progress undetected for many years, impacting multiple organ systems and resulting in a variety of serious and life-threatening complications. By the time they are diagnosed, up to 50% of diabetes patients have one or more of these complications:1
Heart disease and stroke
Diabetic retinopathy that can lead to blindness
Kidney disease
Peripheral vascular disease that can lead lower limb amputations
Current diabetes risk assessment tools fall short.
Type 2 diabetes is a multifactorial disease process with a number of well-known risk factors, including higher-than-normal fasting plasma glucose levels, metabolic syndrome, and obesity.7 However, no single risk factor alone reliably discriminates between those who will develop the disease and those who will not.
A fundamental weakness of most traditional risk assessment tools is that they measure only one of the multiple factors that contribute to diabetes development, and therefore can’t provide a comprehensive profile of true diabetes risk. This shortcoming has forced the “broad brush” interpretation of diabetes risk that has resulted in 79 million American adults being designated as at risk for diabetes – a population too vast to be proactively managed with an eye towards prevention.
Primary care physicians are extremely frustrated by this dilemma because clinical data show that only a small percentage of pre-diabetic patients go on to develop the disease.5 How do they find those patients?
PreDx DRS reveals those at highest risk for diabetes conversion.
The PreDx Diabetes Risk Score (DRS) is a fasting blood test that enables physicians to accurately identify those patients at highest, near-term risk of developing diabetes. It is not a genetic test; genetic markers do not change with a person’s health status. Rather, PreDx DRS is a multi-marker risk assessment tool that reveals the underlying pathophysiology of diabetes – pathophysiology that is treatable and often reversible. The blood markers used in PreDx DRS are dynamic: their levels change with health status. Access to this actionable data enables more-informed patient management decisions that can mitigate the development of disease:
Measures multiple serum markers associated with biological pathways implicated in the development of type 2 diabetes
Employs a complex algorithm based on the quantification of these markers to produce a personalized risk score on a scale of 1 (lower risk) to 10 (highest risk) that correlates with an individual’s absolute risk of developing diabetes within 5 years.
Utilizes standard sample collection and shipment methods
Currently performed exclusively by the CLIA-certified Tethys Clinical Laboratory
Validated in several large independent population studies8,9,10
PreDx DRS is a “wake-up call.”
In 2008, the American College of Endocrinologists and the American Association of Clinical Endocrinologists issued a consensus statement regarding the diagnosis and management of prediabetes. One of their key recommendations for changing the tide of type 2 diabetes stated: 11
“Diagnostic tests should be developed to better distinguish patients who will progress to diabetes from those who will not.”
Tethys’ first product, the PreDx® Diabetes Risk Score (DRS) not only enables physicians to identify their highest risk patients, it also provides them with a powerful motivational tool. Patients for whom the test is ordered receive a score from one (lower) to ten (highest) that tells them their absolute risk of developing diabetes within the next five years.
In testimonials, physicians who have incorporated PreDx DRS into their practices have described dramatic behavioral changes in many patients whose high scores indicate imminent disease risk. For the first time, these patients were motivated to seize control of their health by engaging in weight loss, exercise, dietary and other life-style programs designed to reduce their risk of developing type 2 diabetes.
