8/1/2011 Tethys PreDx® DRS Shows Superior Accuracy in Assessing Type 2 Diabetes Risk vs. Metabolic Syndrome
PreDx DRS Can Be More Effective Clinical Tool to Focus Prevention Efforts on High-Risk Patients
EMERYVILLE, CA – August 1, 2011 – Tethys Bioscience announced the publication of study results showing that the PreDx® Diabetes Risk Score (DRS) is significantly more accurate than metabolic syndrome in assessing individuals’ risk of developing type 2 diabetes. The results underscore that by enabling more accurate risk stratification, PreDx DRS may be a more valuable clinical tool than metabolic syndrome, and allow physicians to more effectively focus preventive strategies on those patients at the highest risk of disease and who are most in need of urgent intervention.
Metabolic syndrome is a cluster of risk factors associated with increased risk for diabetes and/or cardiovascular disease, including central obesity/large waist circumference, elevated blood pressure, elevated fasting serum triglycerides, reduced fasting HDL and elevated fasting plasma glucose. An individual with three of these five criteria is considered to have metabolic syndrome. Studies have shown that metabolic syndrome is a highly imprecise and variable measure of diabetes risk, and solely counting the number of abnormal metabolic syndrome components may provide limited utility in assessing risk for type 2 diabetes in clinical practice.
In contrast, 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 conversion to diabetes 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 improved risk assessment provided by DRS is a function of changes in the 7 markers that are representative of the multiple pathways that are dysregulated in the development of diabetes. In separate studies it has been shown that PreDx DRS can be used to identify patients at risk for diabetes who are most likely to benefit from appropriate medical or lifestyle intervention, to reduce their risk of progressing to diabetes over the long term, and to monitor and potentially improve treatment outcomes.
“The most compelling conclusion from this important study is the confirmation that conventional type 2 diabetes tools, such as metabolic syndrome, are too non-specific and inaccurate to provide the critical information clinicians need to reliably assess and mitigate imminent disease risk among their patients,” said Mickey S. Urdea, PhD, Tethys chairman and chief scientific officer. “Multiple published studies have confirmed that prevention through lifestyle and other interventions can decrease the incidence and prevalence of type 2 diabetes. With PreDx DRS, a laboratory blood test, clinicians have a significantly more valuable stratification tool to help them focus preventive measures on those high-risk patients whose need is greatest and who will benefit the most.”
The study results were published online on July 29th in Public Library of Science (PLoS) ONE, in a paper titled, “Comparison of Accuracy of Diabetes Risk Score and Components of the Metabolic Syndrome in Assessing Risk of Incident Type 2 Diabetes in Inter99 Cohort.” The study was a collaboration among Tethys, Steno Diabetes Center and Glostrup Hospital, Copenhagen.
About the Study and Results
The goal of this study was to compare the accuracy of using PreDx DRS and metabolic syndrome in assessing the risk of developing type 2 diabetes based on their use in clinical practice. The study was conducted utilizing baseline samples from the Inter99 cohort, a randomly selected population of adult Danish subjects who were followed for 5 years and whose diabetes outcomes were known. The accuracy of these two prediction metrics for incident type 2 diabetes was assessed in an unselected population as well as a sub-population of the cohort which was considered to be at increased risk for diabetes based on the presence of impaired fasting glucose (IFG) and/or elevated HbA1c (eHbA1c). Samples from 4,128 subjects were available for analysis after applying exclusion criteria.
Major findings from the study were as follows.
- The sensitivity of metabolic syndrome to predict incident diabetes was 71.4% with a false positive rate of 27.7%. When DRS was matched on false positive rate to metabolic syndrome, DRS had a significantly higher sensitivity (79.9%, p value = 0.023).
- Similarly, when DRS was matched on sensitivity (71.4%) to metabolic syndrome, DRS has a significantly lower false positive rate (20.0%, p value =0.011).
- When metabolic syndrome was used in combination with DRS, there was no significant change in either sensitivity or false positive rate.
- When subjects were reclassified by the number of risk factors they had at baseline (0-2, 3 or 4-5 risk factors), DRS significantly improved the reclassification of subjects at risk for diabetes compared to risk assessment by the number of metabolic syndrome factors (p=0.0008).
- In this study, two of the three American Diabetes Association-defined risk factors for type 2 diabetes, IFG and HbA1c, were used to identify a sub-population at increased risk. The results showed that DRS more accurately stratified the risk of type 2 diabetes in subjects in this increased risk sub-population. This finding highlights the improved performance provided by the combination of biomarkers in DRS compared to metabolic syndrome factors in accurately identifying subjects at increased risk for type 2 diabetes even within the population already identified to be at increased risk.
A copy of the publication by Shafizadeh et al. can be found at www.plosone.org.
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.
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.