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Development of a minimally invasive biomarker assay to detect delayed radiation injury

Award Number: U01AI148308
ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 02/01/2020
PERIOD OF PERFORMANCE END DATE: 01/31/2025

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Development of a minimally invasive biomarker assay to detect delayed radiation injury - PROJECT SUMMARY/ABSTRACT The general population continues to be at risk of exposure to ionizing radiation because of nuclear warfare, terrorism, or radiological accidents. Such exposures are known to cause both short- and long-term injuries in multiple organ systems. Hence, there is an urgent need for FDA-approved biomarkers, with the ability to accurately determine radiation exposure and predict injuries that may follow, based on easily accessible biofluids (e.g., blood) from exposed individuals. The reconstruction of absorbed dose alone does not necessarily identify the type and degree of radiation injury, information that is required for triage and treatment decisions. Thus, effective medical management of a suspected high-dose (i.e., life threatening) exposure necessitates a multiple- parameter-based approach to combine biodosimetry and injury biomarker endpoints. This proposed supplement brings together three inter-disciplinary research teams with expertise in radiation biology, animal models of tissue injury, biomarker development, biostatistics, and bioinformatics to develop the first concept of an analytically validated rapid and minimally invasive assay that constructs both absorbed radiation dose and predicts radiation injury. For this purpose, we will for the first time perform studies to integrate our previously developed FAST- DOSE tool that makes use of leukocyte protein biomarkers, designed for rapid retrospective dose classification/reconstruction within a week after exposure with our CardioWatch panel, a plasma multi-omics panel that predicts the development of late injury in the heart before clinical manifestations are apparent. We will make use of use a highly translational rat model of leg-out X-ray partial body irradiation, which will allow us to collect data on a wide range of early and late organ injuries. Peripheral blood samples collected up to 3 months after irradiation will be used to validate both the FAST-DOSE tool and CardioWatch panel. Echocardiography will provide data on cardiac function at time points up to 9 months after irradiation. Performing these studies in one set of animals will allow us to integrate both assays, using state of the art machine learning approaches. Innovation lies in the different strengths and capabilities of these two biomarker systems which can be used in tandem to correlate in vivo dose reconstruction with radiation injury. The goal of our collaborative supplement is to build on an existing infrastructure and share samples for maximum output. Moreover, the work proposed herein, falls well within the original scope of both approved projects, and speaks to the common goal of building biomarker panels for radiation-specific molecular alterations.


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: 2024 ( Subtotal = $495,650 )
2024	2024	UNIVERSITY OF ARKANSAS FOR MEDICAL SCIENCES	4301 W MARKHAM ST	LITTLE ROCK	AR	72205	PULASKI	USA	Allergy and Infectious Diseases Research	001	5	4/17/2024	SUPPLEMENT FOR EXPANSION	$100,000
2024	2024	UNIVERSITY OF ARKANSAS FOR MEDICAL SCIENCES	4301 W MARKHAM ST	LITTLE ROCK	AR	72205	PULASKI	USA	Allergy and Infectious Diseases Research	002	5	5/23/2024	NON-COMPETING CONTINUATION	$39,565
2024	2024	UNIVERSITY OF ARKANSAS FOR MEDICAL SCIENCES	4301 W MARKHAM ST	LITTLE ROCK	AR	72205	PULASKI	USA	Allergy and Infectious Diseases Research	000	5	2/5/2024	NON-COMPETING CONTINUATION	$356,085
														Subtotal = $495,650

Issue Date FY: 2023 ( Subtotal = $553,162 )
2023	2023	UNIVERSITY OF ARKANSAS FOR MEDICAL SCIENCES	4301 W MARKHAM ST	LITTLE ROCK	AR	72205	PULASKI	USA	Allergy and Infectious Diseases Research	000	4	1/20/2023	NON-COMPETING CONTINUATION	$453,506
2023	2023	UNIVERSITY OF ARKANSAS FOR MEDICAL SCIENCES	4301 W MARKHAM ST	LITTLE ROCK	AR	72205	PULASKI	USA	Allergy and Infectious Diseases Research	001	4	4/4/2023	SUPPLEMENT FOR EXPANSION	$99,656
														Subtotal = $553,162

Issue Date FY: 2022 ( Subtotal = $657,553 )
2022	2022	UNIVERSITY OF ARKANSAS SYSTEM	4301 W MARKHAM ST SLOT 812 BIO-MED BLDG 1 STE 102	LITTLE ROCK	AR	72205	PULASKI	USA	Allergy and Infectious Diseases Research	002	3	1/5/2022	NON-COMPETING CONTINUATION	$457,553
2022	2022	UNIVERSITY OF ARKANSAS SYSTEM	4301 W MARKHAM ST SLOT 812 BIO-MED BLDG 1 STE 102	LITTLE ROCK	AR	72205	PULASKI	USA	Allergy and Infectious Diseases Research	004	3	7/27/2022	NON-COMPETING CONTINUATION	$100,000
2022	2022	UNIVERSITY OF ARKANSAS SYSTEM	4301 W MARKHAM ST SLOT 812 BIO-MED BLDG 1 STE 102	LITTLE ROCK	AR	72205	PULASKI	USA	Allergy and Infectious Diseases Research	003	3	4/8/2022	SUPPLEMENT FOR EXPANSION	$100,000
2022	2021	UNIVERSITY OF ARKANSAS SYSTEM	4301 W MARKHAM ST SLOT 812 BIO-MED BLDG 1 STE 102	LITTLE ROCK	AR	72205	PULASKI	USA	Allergy and Infectious Diseases Research	001	2	12/29/2021	SUPPLEMENT FOR EXPANSION	$0
2022	2021	UNIVERSITY OF ARKANSAS SYSTEM	4301 W MARKHAM ST SLOT 812 BIO-MED BLDG 1 STE 102	LITTLE ROCK	AR	72205	PULASKI	USA	Allergy and Infectious Diseases Research	000	2	11/16/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $657,553

Issue Date FY: 2021 ( Subtotal = $659,044 )
2021	2021	UNIVERSITY OF ARKANSAS SYSTEM	4301 W MARKHAM ST SLOT 812 BIO-MED BLDG 1 STE 102	LITTLE ROCK	AR	72205	PULASKI	USA	Allergy and Infectious Diseases Research	001	2	3/2/2021	SUPPLEMENT FOR EXPANSION	$199,883
2021	2021	UNIVERSITY OF ARKANSAS SYSTEM	4301 W MARKHAM ST SLOT 812 BIO-MED BLDG 1 STE 102	LITTLE ROCK	AR	72205	PULASKI	USA	Allergy and Infectious Diseases Research	000	2	2/3/2021	NON-COMPETING CONTINUATION	$459,161
														Subtotal = $659,044

Issue Date FY: 2020 ( Subtotal = $481,616 )
2020	2020	UNIVERSITY OF ARKANSAS SYSTEM	4301 W MARKHAM ST SLOT 812 BIO-MED BLDG 1 STE 102	LITTLE ROCK	AR	72205	PULASKI	USA	Allergy and Infectious Diseases Research	000	1	1/28/2020	NEW	$481,616
														Subtotal = $481,616

Grand Total All Awards = $2,847,025

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Development of a minimally invasive biomarker assay to detect delayed radiation injury

Award Number: U01AI148308

ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 02/01/2020

PERIOD OF PERFORMANCE END DATE: 01/31/2025

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