REAL-TIME ANALYZERS INC — Department of Defense SBIR Phase II: A18-145

Description

The overall goal of this proposed project (through Phase III) is to develop the Immunosuppressant Drug Monitor to measure tacrolimus at ng/mL levels in oral fluid (saliva) at-home in 10-15 minutes. The monitor will replace the painful blood and plasma tests, currently performed at hospital and clinics, that military patients, who have limb and facial transplants, must undergo to avoid transplant rejection. During the Phase I project, feasibility was demonstrated by developing a lateral-flow assay that allowed detecting tacrolimus artificially spiked in de-identified, oral fluid (saliva) at 1 ng/mL in 15 minutes. The overall goal of the Phase II project is to develop a prototype Immunosuppressant Drug Monitor to measure tacrolimus levels in patient oral fluid. The performance of the prototype device will be validated by comparing tacrolimus concentrations determined for transplant patient plasma by lab methods to concentrations determined from their oral fluid by the Immunosuppressant Drug Monitor. Samples will be obtained under the direction of Dr. Curtis Cetrulo, Director of the Vascularized Composite Tissue Allotransplantation Lab at Massachusetts General Hospital. A regulatory strategy for FDA clearance will be developed.