Non-instrumented Device for Diabetic/Vascular Risk S

Period of Performance: 05/01/2006 - 04/30/2007


Phase 1 SBIR

Recipient Firm

Micronix, Inc.
Carmel, IN 46032
Principal Investigator


DESCRIPTION (provided by applicant): More than half of the world's diabetics and individuals at risk for atherosclerosis due to high blood glucose and lipids (cholesterol, triglyceride) are undiagnosed. A fast growing component of this huge patient population are people with metabolic syndrome. Most of these subjects are generally unaware and thus deprived of the proven benefits of tight glucose control, lifestyle modification, or glucose or lipid lowering medication, because they often do not utilize or have limited access to care facilities and testing. For this reason, and because of the enormous associated socioeconomic implications, National and world professional groups increasingly advocate prevention through case identification and intervention. To this end, National consensus-based cut-point levels for glucose, cholesterol and triglyceride have been proposed for screening, risk stratification and intervention. Motivated by these trends, we propose to develop a compact, non-instrumented, and minimally invasive test wand method designed to visually recognize the proposed cut-points on one (1) individual test strip. Using a patented capillary microfluidic technology, the device doses and transports a miniature blood sample to six (6) polymeric detection sites (test fields), representing two (2) levels for each of the three (3) analytes. After removal of blood cells by capillary force, the 6 levels can be simultaneously evaluated by the user. Visual recognition of the cut-points is enabled by a novel enzymatic threshold assay principle wherein only those test fields show color on which blood levels are higher than the consensus cut-points. Depending on which test fields show color, treatment (lifestyle changes, glucose or lipid lowering medication) can be instituted, preventing or delaying disease development. Another novel feature of the device is that it consolidates all testing components and steps into a single plastic disposable, making test performance extremely easy and safe. The device is expected to have an important and needed analytical, as well as educational role in a very large market. Sale of the product in an over-the-counter mode is seen as the primary market application. Research design and methods for achieving stated development goals are detailed in the proposal. The key scientific disciplines to be applied are clinical chemistry, dry test strip technology, enzymology, mechanical engineering and flow injection molding. The key Phase I objective is to develop the enzymic triglyceride assay and demonstrate its analytical performance. This will be pursued applying the guidelines for sensitivity, specificity, method comparison and precision set forth by the Clinical and Laboratory Standards Institute (CLSI), formerly NCCLS.