MAGNETOMETER FOR HUMAN IRON STORES ASSESSMENT

MEASUREMENT OF HUMAN IRON STORES CAN ACT AS A CLINICALLY SIGNIFICANT INDICATOR OF DISEASE OR POTENTIAL DISEASE. BOTHSTORAGE IRON OVERLOAD AND DEFICIENCY SUGGEST FURTHER EXAMINATION AND POSSIBLE THERAPEUTIC ACTION. FOR EXAMPLE, BLOOD LOSS DUE TO COLORECTAL CANCER WOULD RESULT IN SUBNORMAL STORAGE IRON CONTENT, AND EARLY DETECTION COULD ALLOW CORRECTIVE ACTIONS. INDIRECT MEANS OF MEASURING IRON STORES LACK SENSITIVITY OR SPECIFICITY OR BOTH. PREVIOUSLY AVAILABLE DIRECT MEASURES INVASIVE, DISCOMFORTING AND IN THECASE OF LIVER BIOPSY, RISKY. PIONEERING WORK AT CASE WESTERN RESERVE UNIVERSITY (CWRU) USING CUSTOM-DESIGNED ULTRA-SENSITIVE MAGNETOMETERS SUPPLIED BY S.H.E. CORPORATIONLED TO A NON-INVASIVE MEASUREMENT TECHNIQUE KNOWN A BIOMAGNETIC SUSCEPTOMETRY. PRELIMINARY MEASUREMENTS HAVE DEMONSTRATED THE TECHNICAL MERIT OF THIS TECHNIQUE. THE PHS SBIR SOLICITATION SPECIFICALLY IDENTIFIES THIS SUBJECT AS ONE SUPPORTED BY THE NIADDK (PAGE 17, ITEM 9). SHE PROPOSES IN PHASE I (1) TO RESOLVE THOSE REMAINING INSTRUMENT PROBLEMS IDENTIFIED BY THE CWRU GROUP AS CRITICAL TO CLINICAL APPLICATION OF BIOMAGNETIC SUSCEPTOMETRY AND (2) TO PREPARE A PRELIMINARY DESIGN FOR A COMPLETE PROTOTYPE SYSTEM SUITABLE FOR BOTH CLINICAL STUDIESAND EVENTUAL COMMERCIALIZATION. THESE OBJECTIVES WILL BE ACHIEVED USING BOTH ANALYTICAL AND EMPIRICAL TECHNIQUES. THERE ARE CURRENTLY THREE CRITICAL PROBLEM AREAS -- IMPROVEDRESOLUTION, ENHANCED NOISE REJECTION, AND AUTOMATION OF THE MEASUREMENT PROCEDURE. THE ANALYTICAL WORK WILL BEGIN WITH A CRITICAL REVIEW OF EXISTING EQUIPMENT BUILT BY SHE FOR CWRU AND WITH AN ON-SITE STUDY OF THAT SYSEM IN USE. THIS WILL BE FOLLOWED BY ENGINEERING ANALYSIS OF SUCH ELEMENTS AS PICKUP COIL RESPONSE AND FALSE SIGNALS FROM NEARBY BODY TISSUE. THE EMPIRICAL WORK WILL UTILIZE AN EARLY MODEL CWRUUNIT TO STUDY SPECIFIC HARDWARE PROBLEMS AND TEST POSSIBLE SOLUTIONS. CONSULTATION WITH THE CWRU GROUP WILL BE AN INTEGRAL AND CONTINUING PART OF THE PROGRAM. DETAILED ENGINEERING AND CONSTRUCTION OF THE PROTOTYPE DESIGNED IN PHASE I WILL CONSTITUTE PHASE II. SUCCESSFUL COMPLETION OF PHASE II AND SUBSEQUENT CLINICAL VERIFICATION OF MEDICAL EFFICACY WILL TRIGGER OUR DEVELOPMENT OF A COMMERCIAL VERSION USING PRIVATELY-RAISED FUNDS.