Rapid Low-Cost System for Measuring Percent Hemoglobin A1c

DESCRIPTION (provided by applicant): Scripps has developed a proprietary technology for measuring percent hemoglobin A1c (A1c) that is uniquely suited for the development of simple, low cost test systems. Scripps? goal, through low cost systems, is to make testing more widespread in developed countries, and to make testing for diagnosis and monitoring widely available for the first time in developing countries. Diabetes is epidemic worldwide and places an increasingly heavy cost burden on health care systems. Though professional organizations in developed countries have long called for aggressive treatment of the disease using A1c as a measure of efficacy of treatment, it is still underutilized in part because current systems for decentralized testing of A1c are expensive and/or the cost per test is relatively high. Diabetes is largely undiagnosed and under treated in developing countries, and an A1c test, if inexpensive, could be used to diagnose and monitor diabetes. In Phase I Scripps Laboratories has shown the feasibility of an inexpensive, simple to use strip based "glucometer" type system that will lower testing costs and thus make measurement of A1c more widely available at the point of care in developed countries, and widely available in developing countries. In Phase II buffer and blood addition will be made convenient and technique independent, and the hand-held system brought to market readiness for sale in developing countries. The prototype meter used in Phase I is a mature OEM platform that can be customized for Scripps for a modest investment. The hand-held system, however, will not be competitive with systems currently marketed in developed countries which have more costly, more sophisticated meters. During Phase II Scripps will attempt to find a partner with the financial resources to develop a more sophisticated system that will be competitive, yet less expensive, than these current systems. The strip design and most areas of development for Scripps' hand-held system will apply to the more sophisticated system. Project Narrative: Aggressive treatment of the epidemic of diabetes, monitored by measurement of A1c, is vital to avoid widespread incidence of complications and soaring healthcare costs. In developed countries, Scripps' inexpensive system will make measurement of A1c more widely available at the point of care. In developing countries its low cost would make it the most effective tool for diagnosing and monitoring diabetes.