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AcetaSTAT Validation and Commercialization

Award Number: SB1DK079387
ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 04/01/2008
PERIOD OF PERFORMANCE END DATE: 03/31/2026

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AcetaSTAT Validation and Commercialization - James, Laura P Project Summary/Abstract Acetaminophen (APAP) is the most common drug used for the treatment of pain and fever around the world. It is also the most common cause of life threatening drug-induced liver damage. Unfortunately, physicians have no specific test available to them to confirm the diagnosis of APAP liver injury. Currently, physicians rely on patient history and non-specific tests of liver injury when evaluating patients with liver injury due to APAP. Acetaminophen Toxicity Diagnostics, LLC has developed a rapid lateral flow immunoassay that can detect APAP liver injury. Our test, known as AcetaSTAT, is fast, easy and specific to APAP liver injury. Our plans for this commercialization readiness program proposal include optimizing AcetaSTAT in a collaboration with DCN Diagnostics. Secondly, we will produce AcetaSTAT according to current Good Manufacturing Practice (cGMP). Finally, we will complete in vitro validation studies and perform a multi-site clinical trial to examine the clinical performance of AcetaSTAT. These efforts will support the submission of a de novo application to the Food and Drug Administration for clearance for sales of AcetaSTAT in the US. Ultimately, AcetaSTAT will expedite and simplify the diagnosis of APAP liver injury, prompting more rapid treatment, and saving lives. OMB No. 0925-0001/0002 (Rev. 03/2020 Approved Through 02/28/2023) Page 1


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 = $0 )
2024	2023	ACETAMINOPHEN TOXICITY DIAGNOSTICS, LLC	1 CHILDRENS WAY	LITTLE ROCK	AR	72202	PULASKI	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	10	4/1/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $1,322,119 )
2023	2023	ACETAMINOPHEN TOXICITY DIAGNOSTICS, LLC	1 CHILDRENS WAY	LITTLE ROCK	AR	72202	PULASKI	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	10	4/28/2023	NON-COMPETING CONTINUATION	$1,068,321
2023	2023	ACETAMINOPHEN TOXICITY DIAGNOSTICS, LLC	1 CHILDRENS WAY	LITTLE ROCK	AR	72202	PULASKI	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	10	8/11/2023	SUPPLEMENT FOR EXPANSION	$253,798
														Subtotal = $1,322,119

Issue Date FY: 2022 ( Subtotal = $1,069,721 )
2022	2022	ACETAMINOPHEN TOXICITY DIAGNOSTICS, LLC	1 CHILDREN'S WAY	LITTLE ROCK	AR	72202	PULASKI	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	9	3/30/2022	COMPETING CONTINUATION	$1,069,721
														Subtotal = $1,069,721

Grand Total All Awards = $2,391,840

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AcetaSTAT Validation and Commercialization

Award Number: SB1DK079387

ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 04/01/2008

PERIOD OF PERFORMANCE END DATE: 03/31/2026

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