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Antigen Detection assay for the Diagnosis of Melioidosis

Award Number: R42AI102482
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: 06/15/2012
PERIOD OF PERFORMANCE END DATE: 06/30/2019

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Antigen Detection assay for the Diagnosis of Melioidosis - DESCRIPTION (provided by applicant): Burkholderia pseudomallei is a Gram-negative bacterium that is the causative agent of melioidosis. The bacterium causes significant morbidity and mortality in tropical regions and endemic areas are expanding. Melioidosis is difficult to trea and diagnose due to the fact that B. pseudomallei is resistant to common antibiotics and symptoms are non-specific. Mortality rates reach 45% and 20% in Thailand and Australia respectively, even with antibiotic treatment. Currently, there is no validated diagnostic product for the diagnosis of melioidosis. Culturing of patient samples is the "gold standard" for diagnosis; however this can take 3-7 days. Our goal is to develop a rapid point-of-care lateral flow immunoassay (LFI) for the detection of the B. pseudomallei capsular antigen (CPS) directly from patient samples. Phase I STTR Specific Aims focused on producing a library of anti-CPS monoclonal antibodies (mAbs), optimizing the LFI components and sample preparation, and performing a feasibility study on archived melioidosis patient samples. The objectives of this Phase II application is advanced development and validation of the prototype AMD LFI that incorporates a higher affinity CPS mAb. By completing these goals we hope to produce an optimized LFI that possesses sensitivity equal to or greater than culturing of patient samples. To achieve these goals we have established an experienced team. A strong partnership exists between Dr. AuCoin's laboratory and InBios International that has led to the development of an encouraging prototype LFI. In addition, both groups will work closely with experts in endemic areas (Thailand and Australia) who will be conducting a large preclinical evaluation of the LFI with different patient sample types.


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: 2020 ( Subtotal = $0 )
2020	2016	INBIOS INTERNATIONAL INC	307 WESTLAKE AVE N STE 300	SEATTLE	WA	98109	KING	USA	Allergy and Infectious Diseases Research	000	5	12/10/2019	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2018 ( Subtotal = $0 )
2018	2016	INBIOS INTERNATIONAL, INC	562 1ST AVE S STE 600	SEATTLE	WA	98104	KING	USA	Allergy and Infectious Diseases Research	000	5	6/19/2018	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2016 ( Subtotal = $700,138 )
2016	2016	INBIOS INTERNATIONAL, INC	562 1ST AVENUE SOUTH SUITE 600	SEATTLE	WA	98104	KING	USA	Allergy and Infectious Diseases Research	000	5	6/20/2016	NON-COMPETING CONTINUATION	$700,138
														Subtotal = $700,138

Issue Date FY: 2015 ( Subtotal = $673,521 )
2015	2015	INBIOS INTERNATIONAL, INC	562 1ST AVENUE SOUTH SUITE 600	SEATTLE	WA	98104	KING	USA	Allergy and Infectious Diseases Research	000	4	6/8/2015	NON-COMPETING CONTINUATION	$673,521
														Subtotal = $673,521

Issue Date FY: 2014 ( Subtotal = $621,080 )
2014	2014	INBIOS INTERNATIONAL, INC	562 1ST AVENUE SOUTH SUITE 600	SEATTLE	WA	98104	KING	USA	Allergy and Infectious Diseases Research	000	3	7/1/2014	COMPETING CONTINUATION	$621,080
														Subtotal = $621,080

Grand Total All Awards = $1,994,739

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Antigen Detection assay for the Diagnosis of Melioidosis

Award Number: R42AI102482

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: 06/15/2012

PERIOD OF PERFORMANCE END DATE: 06/30/2019

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