Data Showing Use of Tethys Bioscience, Inc.’s PreDx(R) Diabetes Risk Score Improves Medical Management and Outcomes in Patients at High Risk for Type 2 Diabetes Presented at International Meeting
EMERYVILLE, Calif.--April 7, 2011--Data were presented today showing that utilization of the PreDx® Diabetes Risk Score (DRS) to accurately assess a patient’s risk of developing type 2 diabetes within five years results in more aggressive treatment and follow-up for diabetes prevention among patients whose test scores indicate high risk levels, as well as statistically significant improvements in their cardiometabolic risk factors, compared to patients with lower test scores and those not tested with PreDx DRS. The strong correlation among accurate risk assessment, risk reduction and improved medical outcomes suggests that utilization of PreDx DRS contributes to more careful diabetes risk monitoring and more effective preventive and therapeutic intervention than reliance upon traditional risk assessments.
The data were presented at the Fourth International Congress on Prediabetes and the Metabolic Syndrome, held in Madrid, Spain, in a presentation titled, “A Comparative Study of the Use of the Diabetes Risk Score (DRS) in Primary Care: How Are Medical Management and Patient Outcomes Affected?” authored by S. E. Conard, et al.
PreDx Diabetes Risk Score (DRS) is a multi-marker fasting blood test that assesses markers of inflammation, fat cell function, and glucose metabolism. The DRS categorizes individuals as low, moderate, or high risk for diabetes conversion within 5 years, and has been shown to be significantly more accurate than HbA1c or fasting glucose. Medical Edge Healthcare Group in Dallas, Texas, conducted the retrospective observational study using electronic medical records in order to evaluate the impact of PreDx DRS on clinical practice and patient care in a natural primary care practice setting.
“Today we face several challenges in diabetes prevention. Use of evidence-based interventions before disease diagnosis has been traditionally low, and with 79 million Americans already considered pre-diabetic, we have too many patients to treat effectively. This study provides strong evidence that PreDx DRS is not only a powerful risk assessment tool, but also an important prevention tool, enabling physicians to more effectively direct resources to patients with the greatest need for intervention, and motivating physicians and patients to employ preventive measures,” said Mickey S. Urdea, PhD, chairman and chief executive officer of Tethys.
“Careful monitoring of risk factors is essential to patient behavioral change and effective medical management,” said Scott Conard, MD, chief medical officer of Medical Edge. “PreDx DRS captures essential information about the physiology of our patients, and provides an easy-to-understand diabetes risk score which can contribute to enhanced monitoring of diabetes risk and the use of more appropriate preventive therapy for higher-risk individuals. The evidence showing that patients with high diabetes risk scores were more aggressively treated for risk factor control strongly suggests that these patients and physicians were more engaged in reducing risk factors when this test was applied.”
About the Observational Study and Results
The Tethys sponsored study included data on 696 patients age 30 or older who received the PreDx DRS test between June and December 2010 with valid test results and no prior diagnosis of diabetes. A total of 35 physicians ordered the PreDx test for at least one patient during this period. A control un-tested group was randomly selected in a 3:1 ratio to DRS-tested patients to match gender and age distributions from those who had at least one measurement of LDL, blood pressure, and weight in the 18 months prior to the reference date, and had no record of visiting a physician known to be ordering PreDx DRS tests. Biometric, diagnosis, and prescription records of all selected patients were extracted for the 18 months prior to the reference date of October 1, 2010 and all dates afterwards (mean follow-up 4 months).
Biometric measures included blood pressure, LDL, HDL, weight, HbA1c, triglycerides, fasting glucose, and HbA1c. Per-patient means were computed for the periods before and after the reference date. Diagnoses examined were hypercholesterolemia and hypertension. Prescriptions for anti-hypertensives, lipid-lowering agents, anti-diabetic agents, and aspirin written after the reference date were compiled. Differences in intensity of care between controls, and low, moderate, and high scoring DRS patients were evaluated by subsequent risk factor monitoring rates, use of pharmacological agents, and improvement in risk-factor control. P-values were computed using a two-tailed chi-square test.
- Patients who received the PreDx DRS test were more likely to have follow-up monitoring of biometric risk factors by a physician relative to similar patients who did not receive the test, including measurements of lipid and glucose control (p<0.001).
- Patients with high PreDx DRS diabetes risk scores were more aggressively treated for risk factor control than those with lower PreDx scores or no test, including use of aspirin, antihypertensive agents, lipid lowering therapies and other agents (p<0.01)
- There was significant improvement of risk-factors in patients who received the PreDx test, including weight, blood pressure, and cholesterol measures (p<0.001).
A copy of the poster presented today is available from Tethys upon request.
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, nontraumatic 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. For more information about PreDx DRS, please visit www.predxdiabetes.com.
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.