Phase II year
2020
(last award dollars: 2023)
Phase II Amount
$2,299,209
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.
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The overall goal of this proposed project (through Phase III) is to develop the Tacrolimus At-home Saliva Test (TAST) to measure tacrolimus at ng/mL levels in oral fluid (saliva) at-home in 15-20 minutes. The TAST will replace the painful blood tests currently performed at hospital and clinics that military patients, who have limb, facial and organ transplants, must undergo to avoid transplant rejection. During the SBIR Phase I project, feasibility was demonstrated by developing a lateral-flow assay (LFA) that allowed detecting tacrolimus artificially spiked in de-identified, oral fluid (saliva) at 1 ng/mL in 15 minutes. During the SBIR Phase II project, a prototype TAST was produced consisting of a finalized LFA and a smartphone. An App on the smartphone was written to measure the intensity of the LFA Test Line using the smartphone camera. Measurements of tacrolimus in saliva samples collected at Mass General Brigham (MGB) hospital under the direction of Dr. Curtis Cetrulo, Director of the Vascularized Composite Tissue Allotransplantation Lab, showed an excellent correlation to standard blood samples. The proposed SBIR Phase II Sequential project shall produce and employ 10 TASTs to measure ~75 patients at MGB and ~75 patients at the Arizona VA Health Care System (SAVAHCS), under the direction of Dr. Bekir Tanriover Chief of Nephrology at SAVAHCS. The data will be submitted as a Class 1 510(k) device to the FDA for clearance.The overall goal of this proposed project (through Phase III) is to develop the Tacrolimus At-home Saliva Test (TAST) to measure tacrolimus at ng/mL levels in oral fluid (saliva) at-home in 15-20 minutes. The TAST will replace the painful blood tests currently performed at hospital and clinics that military patients, who have limb, facial and organ transplants, must undergo to avoid transplant rejection. During the SBIR Phase I project, feasibility was demonstrated by developing a lateral-flow assay (LFA) that allowed detecting tacrolimus artificially spiked in de-identified, oral fluid (saliva) at 1 ng/mL in 15 minutes. During the SBIR Phase II project, a prototype TAST was produced consisting of a finalized LFA and a smartphone. An App on the smartphone was written to measure the intensity of the LFA Test Line using the smartphone camera. Measurements of tacrolimus in saliva samples collected at Mass General Brigham (MGB) hospital under the direction of Dr. Curtis Cetrulo, Director of the Vascularized Composite Tissue Allotransplantation Lab, showed an excellent correlation to standard blood samples. The proposed SBIR Phase II Sequential project shall produce and employ 10 TASTs to measure ~75 patients at MGB and ~75 patients at the Arizona VA Health Care System (SAVAHCS), under the direction of Dr. Bekir Tanriover Chief of Nephrology at SAVAHCS. The data will be submitted as a Class 1 510(k) device to the FDA for clearance.
