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Highly Sensitive and Specific MSD Multiplexed Autoimmune Disease Panel

Award Number: U24AI118660
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: 07/06/2015
PERIOD OF PERFORMANCE END DATE: 08/31/2022

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Highly Sensitive and Specific MSD Multiplexed Autoimmune Disease Panel - DESCRIPTION (provided by applicant): Autoimmune diseases are chronic debilitating conditions that collectively affect 5 to 8 % of the US population. The high prevalence of autoimmune diseases and the recognition that individuals who develop organ-specific autoimmune conditions have a high likelihood of developing additional autoimmune disorder(s) calls for the development of new technologies that can measure multiple immune reactivities simultaneously in a small sample volume. Detection of these diseases before onset or at early stages can help in making effective treatment decisions. Although multiplexing of up to 13 relevant assays for systemic autoimmune diseases has been achieved, broader panels have not been developed to assess the range of organ-specific autoimmune diseases such as Type 1 Diabetes and Celiac disease. Furthermore, no multiplexed assay panels exist that use a bridging immunoassay format, which provides higher assay specificity as compared to classical serological assay formats. The goal of the proposed program is to develop a novel, highly sensitive, and specific solution-based multiplexed bridging immunoassay panel that can simultaneously detect patient autoantibodies for 25 different autoimmune reactivities relevant to at least 12 major organ-specific autoimmune diseases. The multiplexed autoantibody detection panel will use sensitive Meso Scale Diagnostics, LLC. (MSD) MULTI-ARRAY technology. Our collaborators at the University of Florida, Dr. W.E. Winter and D. Pittmann, will provide their extensive expertise in clinical laboratory assessment of autoimmune diseases related to obesity, diabetes and the metabolic syndrome, and will provide high quality case and control samples for use in panel development, testing, and validation.


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 = -$6,224 )
2024	2019	MESO SCALE DIAGNOSTICS LLC	1601 RESEARCH BLVD	ROCKVILLE	MD	20850	MONTGOMERY	USA	Allergy and Infectious Diseases Research	000	5	10/11/2023	NON-COMPETING CONTINUATION	-$6,224
														Subtotal = -$6,224

Issue Date FY: 2022 ( Subtotal = $0 )
2022	2019	MESO SCALE DIAGNOSTICS, LLC	1601 RESEARCH BLVD	ROCKVILLE	MD	20850	MONTGOMERY	USA	Allergy and Infectious Diseases Research	000	5	2/25/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $0 )
2020	2019	MESO SCALE DIAGNOSTICS, LLC	1601 RESEARCH BLVD	ROCKVILLE	MD	20850	MONTGOMERY	USA	Allergy and Infectious Diseases Research	000	5	9/11/2020	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2019 ( Subtotal = $365,689 )
2019	2019	MESO SCALE DIAGNOSTICS, LLC	1601 RESEARCH BLVD	ROCKVILLE	MD	20850	MONTGOMERY	USA	Allergy and Infectious Diseases Research	000	5	6/24/2019	NON-COMPETING CONTINUATION	$365,689
														Subtotal = $365,689

Issue Date FY: 2018 ( Subtotal = $372,825 )
2018	2018	MESO SCALE DIAGNOSTICS, LLC	1601 RESEARCH BLVD	ROCKVILLE	MD	20850	MONTGOMERY	USA	Allergy and Infectious Diseases Research	000	4	6/19/2018	NON-COMPETING CONTINUATION	$372,825
														Subtotal = $372,825

Issue Date FY: 2017 ( Subtotal = $378,850 )
2017	2017	MESO SCALE DIAGNOSTICS, LLC	1601 RESEARCH BLVD	ROCKVILLE	MD	20850	MONTGOMERY	USA	Allergy and Infectious Diseases Research	000	3	6/28/2017	NON-COMPETING CONTINUATION	$378,850
														Subtotal = $378,850

Issue Date FY: 2016 ( Subtotal = $386,814 )
2016	2016	MESO SCALE DIAGNOSTICS LLC	9238 GAITHER ROAD	GAITHERSBURG	MD	20877	MONTGOMERY	USA	Allergy and Infectious Diseases Research	001	2	6/16/2016	NON-COMPETING CONTINUATION	$386,814
2016	2015	MESO SCALE DIAGNOSTICS LLC	9238 GAITHER ROAD	GAITHERSBURG	MD	20877	MONTGOMERY	USA	Allergy and Infectious Diseases Research	000	1	10/29/2015	NEW	$0
														Subtotal = $386,814

Issue Date FY: 2015 ( Subtotal = $395,359 )
2015	2015	MESO SCALE DIAGNOSTICS LLC	9238 GAITHER ROAD	GAITHERSBURG	MD	20877	MONTGOMERY	USA	Allergy and Infectious Diseases Research	000	1	7/2/2015	NEW	$395,359
														Subtotal = $395,359

Grand Total All Awards = $1,893,314

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Highly Sensitive and Specific MSD Multiplexed Autoimmune Disease Panel

Award Number: U24AI118660

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: 07/06/2015

PERIOD OF PERFORMANCE END DATE: 08/31/2022

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