SUN-068 Clinical Validation Of A Novel Cardio-metabolic Diagnostic Technology

Hypercholesterolemia is a cardio-metabolic disease caused by a disruption in low density lipoprotein (LDL) cholesterol metabolism. Proprotein convertase subtilisin-kexin 9 (PCSK9) is an indirect regulator of plasma LDL levels by controlling the number of LDL receptor molecules expressed at the plasma membrane. Serum levels of PCSK9, along with associated mutations, dictate the severity of the hypercholesterolemic condition. Although several treatment options are available to treat hypercholesterolemia, a cost-effective and quick test to best qualify patients for appropriate treatment is currently lacking. We have developed and validated a diagnostic tool to be used in a clinical setting which measures PCSK9 levels in a currently unreported manner. The results from this tool will give predictive instructions to physicians as to which hypercholesterolemic treatment will best suite the patient, preventing the development of alternative diseases (such as Type 1 and Type 2 diabetes) currently being observed by the trial-and-error methods of treatment. We have used disease (diabetic) and non-disease (non-diabetic) state human samples to validate the use of our diagnostic test for clinical use. The human samples were used in clinical trials to measure the effectiveness of the diagnostic tools in personalized medicine. The results showed the diagnostic tool has the ability to determine which patients have genetic mutations in PCSK9 that will result in the progression of their diabetic condition under generalized Statin recommendations.