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A rapid point-of-care test for therapeutic drug monitoring of tacrolimus

Award Number: R43TR005794
ORGANIZATION: NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 07/01/2025
PERIOD OF PERFORMANCE END DATE: 06/30/2026

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A rapid point-of-care test for therapeutic drug monitoring of tacrolimus - ABSTRACT This proposal seeks to develop and characterize a point-of-care testing platform to enable rapid, bedside, or at- home measurement of tacrolimus (TAC), a critical immunosuppressive drug used in organ transplantation. As TAC accounts for approximately 90% of renal transplant regimens and requires lifelong therapeutic drug monitoring (TDM) due to its narrow therapeutic index, the current reliance on centralized laboratory testing and venous blood draws presents significant challenges. These challenges include delays in dosage adjustments, increased healthcare costs, and substantial logistical burdens for patients and providers. To address these issues, BioStealth will adapt the D4 immunoassay platform, originally developed at Duke University, for the detection of small molecules like TAC. Our project is motivated by the pressing need for a more accessible and timely method for TAC monitoring that could improve both short- and long-term outcomes in transplant patients. By enabling bedside or patient-led monitoring, we aim to replace the current clinical paradigm, which often results in delayed dose titrations, increasing the risk of either organ rejection due to under-suppression or drug-related toxicity due to over-suppression. Furthermore, our technology holds the potential to facilitate the implementation of area-under-the-curve (AUC)-based dosing, a strategy that has been shown to reduce toxicity but is rarely used in clinical practice due to the complexity and demands of current TDM approaches. The career development plan is designed to equip the PD/PI with the entrepreneurial and operational skills necessary to transition into a leadership role in the biotech industry. With a strong background in biomedical engineering and hands-on experience with the D4 immunoassay platform, the PD/PI seeks to fill gaps in startup activities, project management, and commercialization. This will be achieved through structured programs like C3i or I-Corps, regular mentoring from experienced professionals, and active participation in networking and learning opportunities. The mentor, Dr. Ashutosh Chilkoti, will provide ongoing guidance in both scientific and entrepreneurial aspects, ensuring the PD/PI is well-prepared to lead BioStealth toward successful commercialization.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2027 ( Subtotal = -$17 )
2027	2025	SIMPLUSDX, INC.	3644 LAUREL CREEK WAY	DURHAM	NC	27712	DURHAM	USA	National Center for Advancing Translational Sciences	000	1	10/21/2026	NEW	-$17
														Subtotal = -$17

Issue Date FY: 2025 ( Subtotal = $306,299 )
2025	2025	SIMPLUSDX, INC.	3644 LAUREL CREEK WAY	DURHAM	NC	27712	DURHAM	USA	National Center for Advancing Translational Sciences	000	1	6/20/2025	NEW	$306,299
														Subtotal = $306,299

Grand Total All Awards = $306,282

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A rapid point-of-care test for therapeutic drug monitoring of tacrolimus

Award Number: R43TR005794

ORGANIZATION: NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 07/01/2025

PERIOD OF PERFORMANCE END DATE: 06/30/2026

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