Tethys PreDx® Diabetes Risk Score (DRS) Shown to Improve the Cost-effectiveness of Diabetes Prevention

July 10, 2011

Study Shows Using PreDx DRS to Identify Patients at Highest Risk for Diabetes Can Result in Long-Term Healthcare System Cost Savings

EMERYVILLE, Calif.--Tethys Bioscience announced the publication of study results showing that the cost-effectiveness of type 2 diabetes prevention can be significantly improved when the PreDx Diabetes Risk Score (DRS) is used to identify patients at highest risk for diabetes. Most notably, utilization of the PreDx DRS for diabetes risk stratification can produce long-term cost savings for the healthcare system.

The publication reported results from a study comparing the costs and benefits of using the PreDx DRS to identify individuals at high risk of developing type 2 diabetes within a patient population that has impaired fasting glucose (IFG), a well-known risk factor for diabetes. Data showed that combining the use of IFG plus the PreDx DRS improved identification among those at highest risk of developing type 2 diabetes compared to using IFG alone, and that over time, use of the PreDx DRS could produce significant health economic benefits by reducing healthcare expenditures for the prevention and treatment of type 2 diabetes.

The study results were published in the July issue of the Journal of Medical Economics, in a paper titled, “Cost-Effectiveness of Risk Stratification for Preventing Type 2 Diabetes Using A Multi-Marker Diabetes Risk Score,” by Sean D. Sullivan, PhD, et al. Dr. Sullivan is Professor and Director, Pharmaceutical Outcomes Research and Policy Program, University of Washington.

“Our data show that the cost-effectiveness of diabetes prevention programs can be improved by using the PreDx DRS to identify those patients at highest risk for diabetes,” said Dr. Sullivan. “As compared to treating all patients with IFG – an approach that is unlikely to result in net cost savings in this population – risk stratification using the DRS may ultimately result in cost reductions for the health care system. These findings are especially important given the fact that current risk assessment tools identify large segments of the population as ‘at risk’ for diabetes, making it difficult to implement cost-effective diabetes prevention programs. Clearly, more accurate tools for identifying those at highest risk for diabetes, such as the PreDx DRS, are needed to advance diabetes prevention, improve health outcomes and lower healthcare costs.”

“These compelling data are especially meaningful to employers, payers and policy makers who are urgently seeking prevention solutions to stem the tide of the type 2 diabetes epidemic,” said Mickey S. Urdea, PhD, Tethys chairman and chief scientific officer. “Today, the at-risk diabetes population identified by current methodologies is simply too large for focused, cost-effective intervention, and few of these individuals are at real, near-term risk. These study results demonstrate the health economic advantages of using the PreDx DRS to identify those who can benefit most from preventive intervention thereby enabling health care professionals to allocate resources to patients at imminent risk while there is still time to prevent disease progression, thus reducing the economic and public health burden of this devastating disease.”

About the Study and Results
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 diabetes conversion 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 PreDx DRS test 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 aim of this study was to compare the potential costs and health benefits of two approaches for identifying those at high risk of developing type 2 diabetes for entry into a diabetes prevention program:

--The first approach identified patients with IFG as high-risk.
--The second approach used the DRS to further stratify patients with IFG into high-risk and moderate-risk groups.

The potential cost-effectiveness of each of these two approaches was estimated using models that simulated the incidence and disease progression of diabetes and the consequent costs and quality-adjusted life expectancy (QALY) comparing alternative approaches for identifying patients to be in a diabetes prevention and surveillance program. The perspective of a United States (US) healthcare system was used, i.e., including only direct medical costs. The cost-effectiveness of alternative scenarios was examined over 5 to 10-year time horizons, with 5 years as the base-case horizon.

Results showed that:
--Stratification of IFG patients by the PreDx DRS method leads to improved identification of those at highest risk for development of diabetes.
--At 5 years, the number needed to treat (NNT) in the IFG only approach was 39 patients to prevent 1 case of diabetes compared to an NNT of 15 in the IFG+DRS approach.
--When compared to IFG alone, the IFG+DRS approach results in an incremental cost-effectiveness ratio (ICER) of $17,100/quality-adjusted life year (QALY) gained at 5 years and would become cost-saving in 10 years.
--In contrast, and as compared to no stratification, the IFG-only approach would produce an ICER of $235,500/QALY gained at 5 years and $94,600/QALY gained at 10 years.

A copy of the paper is available from Tethys upon request.

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. For more information about PreDx DRS, please visit www.predxdiabetes.com.

About Tethys
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 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. The PreDx DRS is performed solely at the Tethys Clinical Laboratory in Emeryville, CA. For more information about Tethys and PreDx DRS, please visit www.tethysbio.com.