The diabetes epidemic, and the devastating complications that accompany it, have created an unprecedented worldwide medical crisis. It is primarily the complications of diabetes, including kidney failure, blindness, cardiovascular disease and neuropathy that accounts for the $245 billion spent in 2012 in the US. A significant problem for doctors who treat diabetic patients is the 5-15 year "silent phase" after onset of the disease, when approximately 1/3 of the diabetic population progresses rapidly toward complications but with no overt clinical symptoms. Until now, physicians have been unable to predict which patients are most likely to develop these complications, and hence are unable to tailor medical treatment to their specific individual needs. By the time symptoms are apparent, it is often too late to change the outcome, even with more aggressive treatment. Patients who are unaware of their risks are often complacent and unresponsive when knowledge of this risk would prompt more attentive behavior that could dramatically change their outcome. PreventAGE's overreaching objective is change the current paradigm, fundamentally improving the care of patients with diabetes by providing diagnostic tests that will predict individual propensity to diabetic complications well before clinical evidence is apparent. This product fills an essential, unmet market need, providing doctors and patients with the predictive information necessary to make proactive, individualized decisions about diabetes care. Early, aggressive treatment for patients at greatest risk of complications will significantly reduce these complications and their associated suffering, mortality and exorbitant expense. Recent groundbreaking research has identified 3 biomarkers, which proved to be predictive of diabetic kidney disease well before clinical evidence was apparent. There is strong scientific evidence that these and/or other identified Advanced Glycation Endproducts (AGEs) or Oxidative Products (OPs) biomarkers will predict risk for progression to retinopathy, neuropathy and cardiovascular disease as well. The DCCT, the most important diabetes outcome study ever done, has agreed to collaborate with PreventAGE and will provide plasma and urine samples collected from patients over a 25 year period, with the degree of progression to the various complications carefully documented. In Phase 1 we will enhance current LC-MS/MS methodology to meet large-scale volume and quality goals, assure the chemical stability of the plasma samples, and determine that satisfactory with in, and between-subject variability of the levels of AGEs and OPs exist. In Phase 2, we will test samples to assess the extent to which information provided by new biomarker assays are predictive for risks of kidney disease, retinopathy and cardio-vascular disease. Confirmation of current and new predictive biomarkers for these additional complications will enhance the value of PreventAGE's current testing service to researchers, provide a clinical testing service for doctors and lead to the development of a cost-effective, readily available, assay using monoclonal antibodies.

Public Health Relevance

PreventAGE Health Care provides a precision, prognostic evaluation, based on a panel of biomarkers, which identifies those patients with diabetes who are most likely to develop specific complications associated with their disease. This new blood test will inform patients of their own risks and lead to more appropriate treatment programs, tailored to address that person's unique profile. The company's mission is to improve the lives of the 26 million people in the US with diabetes, and significantly reduce the $245 billion dollars spent annually on the disease.

National Institute of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
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Special Emphasis Panel (ZRG1-EMNR-S (10))
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Arreaza-Rubin, Guillermo
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Preventage Healthcare, LLC
United States
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