Official websites use .gov

A .gov website belongs to an official government organization in the United States.

Secure .gov websites use HTTPS

A lock ( 🔒 ) or https:// means you've safely connected to the .gov website. Share sensitive information only on official, secure websites.

Need Help

Precision Diagnostics in T-cell Mediated Rejection: Predicting Treatment Resistance at Time of Diagnosis

Award Number: R43AI197708
ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/12/2026
PERIOD OF PERFORMANCE END DATE: 07/31/2027

Group Awards By:

View Award Description

Precision Diagnostics in T-cell Mediated Rejection: Predicting Treatment Resistance at Time of Diagnosis - Title: Precision Diagnostics in T-cell Mediated Rejection: Predicting Treatment Resistance at Time of Diagnosis PROJECT SUMMARY The goal of this Phase I SBIR is to build a predictive test for treatment responsiveness of acute T-cell mediated rejection (TCMR) of kidney transplants. The test will be based on gene expression profiles of diagnostic biopsies identified via whole transcriptome sequencing as well as a novel clinical definition of treatment resistance. Kidney transplantation is the best alternative patient survival, patient-reported outcomes and health economics perspectives for the treatment of chronic kidney disease (CKD). However, immunologic rejection poses a threat to long-term survival of the graft, with TCMR well-documented as the primary mechanism for graft failure. The occurrence of TCMR shortens graft survival, and it has been known for many years that the currently available therapies for treatment of TCMR fail 30-50% of the time, leading to further shortening of graft survival. Current therapies for treatment of TCMR can cause profound immunosuppression, leading to mortality by opportunistic infections or malignancies. If successful, this project will yield the first rapid, clinically actionable test to predict treatment resistance in acute T-cell mediated rejection (TCMR), empowering clinicians to tailor immunosuppression strategies and avoid unnecessary harm from ineffective therapies. Eventually the assay could also identify patients and samples for future research into the mechanisms of resistance to current rejection therapies. The Principal Investigator, Shana Coley, MD, PhD, led previous translational research (funded by NIAID), showing that treatment resistant TCMR can be detected by intra-graft gene expression within the diagnostic biopsy material, using a whole transcriptome sequencing approach on archived formalin-fixed paraffin-embedded biopsy tissue. Furthermore, we identified a 27 gene signature predictive of treatment resistance within the diagnostic biopsy of TCMR. However, whole transcriptome sequencing is not a practical approach for real-world timely diagnostics in kidney transplantation where treatment must be initiated immediately. Therefore, we propose to develop an orthogonal approach using a rapid qPCR-based method to detect gene transcripts predictive of treatment resistance, so that results can be delivered in a clinically meaningful time frame for effective patient care. The results from this test would provide material benefit to patients immediately in the form of avoidance of the significant risks from over-immunosuppression when a rejection episode is determined unlikely to respond to current standard treatment. In Phase II, the results from Phase I will be translated into a clinically validated assay offered through Arkana Laboratories molecular diagnostic laboratory, establishing the first precision diagnostic test to guide immunosuppressive treatment decisions in kidney transplant patients.


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: 2026 ( Subtotal = $266,613 )
2026	2026	NEPHROPATHOLOGY ASSOCIATES, PLC	10810 EXECUTIVE CENTER DR STE 100	LITTLE ROCK	AR	72211	PULASKI	USA	Allergy and Infectious Diseases Research	000	1	8/12/2026	NEW	$266,613
														Subtotal = $266,613

Grand Total All Awards = $266,613

Top

All Categories

About

Search

Reports

Data Submission

Award Information

Precision Diagnostics in T-cell Mediated Rejection: Predicting Treatment Resistance at Time of Diagnosis

Award Number: R43AI197708

ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 08/12/2026

PERIOD OF PERFORMANCE END DATE: 07/31/2027

Federal Websites

Department of Health & Human Services

HHS Operating Divisions

HHS Staff Divisions

Download A Document Viewer