Whole Blood Point of Care Metabolic Measurement

Project Summary This SBIR Phase II project will translate Phase I technical innovations in sensor materials and a prototype device into a fully functional point of care technology for whole blood biomarker monitoring. It will culminate in a complete draft of a 510(k) clearance application to the U.S. Food and Drug Administration (FDA). Currently, no commercial FDA cleared point of care device is available for direct measurement of this biomarker in whole blood. All large clinical instruments require separation of plasma from whole blood via centrifugation prior to measurement. Further, current clinically used measurements, which rely on plasma separated from whole blood, suffer from inaccurate results from pre-analytical variability in sample handling. Phase I completed technical innovations supported by the National Science Foundation yielded 1) increased sensor specificity, by eliminating signals from interferents, 2) increased sensor sensitivity through sensing material improvements, and 3) direct point of care measurement from whole blood, instead of plasma separated ex-situ from the measurement device which eliminated pre-analytical variability in sample handling. This novel point of care whole blood measurement device will be used to improve at-home management of the ~10,000 people living with these rare metabolic disorders and as a newborn screening to improve identification of the ~1/3500 newborns with rare metabolic disorders out of the 3.9 million annual births in the United States. Ultimately, manufacturing of consumable, single use sensors and sensor readers will create new jobs in the United States. In this Direct Phase II project, Sequitur Health Corp. will partner with Arizona State University and Mayo Clinic to innovate a process for mass production of the laboratory-scale sensors developed from the Phase I project and subsequently analytically and clinically validate the mass-produced sensors and reader technology for FDA 510(k) clearance.