CORONARY HEART DISEASE RISK PROFILING SYSTEM

OVER 540,000 PEOPLE DIE IN THE UNITED STATES EVERY YEAR FROM CORONARY HEART DISEASE (CHD), AND AN ADDITIONAL 6 MILLION PERSONS HAVE DIAGNOSED CHD. TWO OF THE MORE IMPORTANT CHD RISK FACTORS ARE THE SERUM LEVEL OF LOW-DENSITY LIPOPROTEIN CHOLESTEROL (LDL-CHOL) AND HIGH-DENSITY LIPOPROTEIN CHOLESTEROL (HDL-CHOL). THIS INSTRUMENT SYSTEM WILL AUTOMATICALLY PERFORM A COMPLETE SERUM CHD RISK PROFILE CONSISTING OF TOTAL-CHOL, LDL-CHOL, HDL-CHOL, AND TRIGLYCERIDES IN A SINGLE, UNIQUE, DISPOSABLE DEVICE. THE SYSTEM WILL BE TARGETED AT THE PHYSICIAN'S OFFICE MARKET. THE GOALS OF THE PHASE I PROJECT ARE TO: (1) DEVELOP A FINAL DISPOSABLE DEVICE PROTOTYPE, (2) DEVELOP AN INSTRUMENTBREADBOARD, AND (3) DEMONSTRATE THE VALIDITY OF THE INTEGRATED DEVICE AND INSTRUMENT SYSTEM. THE INSTRUMENT BREADBOARD WILL BE DEVELOPED USING HARDWARE AND SOFTWARE MODULES ALREADY DESIGNED BY PEGASUS TECHNOLOGIES FOR A DIFFERENT SYSTEM. THE VALIDITY OF THE DEVICE AND SYSTEM WILL BE DEMONSTRATED BY GENERATING ACCURACY AND PRECISION DATA USING A SERIES OF HUMAN SERUM SAMPLES THAT HAVE CDC-CALIBRATED LIPID-CHOLESTEROL VALUES. THIS SYSTEM WILL PROVIDE A COMPLETE LIPID PROFILE FASTER, MORE RELIABLY, AND LESS EXPENSIVELY THAN THE EXISTING METHODS.