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NEXT-GEN Oral test for monitoring HIV/AIDS in Point-of-Care

Award Number: R44DE021672
ORGANIZATION: NATIONAL INSTITUTE OF DENTAL AND CRANIOFACIAL RESEARCH
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/15/2011
PERIOD OF PERFORMANCE END DATE: 08/31/2019

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NEXT-GEN Oral test for monitoring HIV/AIDS in Point-of-Care - DESCRIPTION (provided by applicant): NEXT-GEN Oral test for monitoring HIV/AIDS in Point-of-Care The ultimate goal of this project is to develop a new point-of-care test for acute HIV screening and therapeutic monitoring of HIV/AIDS in Point-of-care. The commercial product will be a compact sample-to-answer system with disposable cartridges, capable of achieving CLIA waiver. The test will be rapid (<20 minutes) and inexpensive (<$2). The test will measure HIV viral load and host response biomarkers in whole saliva using a microchip device. The device consists of a label-free, multiplexed immunoassay on a disposable microfluidic microchip coupled with a nanoplasmonic reader. Phase I R&D produced core innovations for the proposed product: candidate saliva biomarkers with >96% diagnostic accuracy for acute and unsuppressed HIV infection, and a prototype microfluidic device. These Phase I deliverables provide a solid foundation for the proposed Phase II activities. Key technical objective is to clinically validate the microchip device based on a high diagnostic accuracy for acute and unsuppressed HIV infection in a cross-section of HIV/AIDS patients and controls. SA1 will obtain N=195 saliva samples from 7 cohorts of HIV/AIDS patients and controls. SA2 will validate the diagnostic accuracy of the candidate biomarkers using the clinical saliva samples from SA1. The biomarkers will be measured using a high throughput saliva IHC immunoassay, and confirmed using orthogonal assays: Western blot and SRM mass spectroscopy. SA3 will adapt the prototype microchip device to measure HIV viral load and the candidate biomarkers in whole saliva. The new platform will be validated analytically based on high sensitivity, accuracy and reliability. Clinical validation will be demonstrated based on ≥99% diagnostic accuracy for unsuppressed and acute HIV in clinical saliva samples from SA1. This milestone will provide key GO criteria for the commercial product development in Phase III. The proposed product has potential to radically improve the "test and treat" HIV strategy, help to reduce new infections, increase access to care and improve health outcomes for people living with HIV.


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	2017	GAIA MEDICAL INSTITUTE, LLC, THE	505 COAST BLVD SOUTH, STE 104	LA JOLLA	CA	92037	SAN DIEGO	USA	Oral Diseases and Disorders Research	000	3	5/3/2020	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2018 ( Subtotal = $162,910 )
2018	2018	GAIA MEDICAL INSTITUTE, LLC, THE	505 COAST BLVD SOUTH, STE 104	LA JOLLA	CA	92037	SAN DIEGO	USA	Oral Diseases and Disorders Research	000	3	9/11/2018	SUPPLEMENT FOR EXPANSION	$162,910
														Subtotal = $162,910

Issue Date FY: 2017 ( Subtotal = $374,022 )
2017	2017	GAIA MEDICAL INSTITUTE, LLC, THE	505 COAST BLVD SOUTH, STE 104	LA JOLLA	CA	92037	SAN DIEGO	USA	Oral Diseases and Disorders Research	000	3	8/18/2017	NON-COMPETING CONTINUATION	$374,022
														Subtotal = $374,022

Issue Date FY: 2016 ( Subtotal = $434,121 )
2016	2016	GAIA MEDICALINSTITUTE LLC	12650 INTERMEZZO WAY	SAN DIEGO	CA	92130	SAN DIEGO	USA	Oral Diseases and Disorders Research	000	2	8/29/2016	COMPETING CONTINUATION	$434,121
														Subtotal = $434,121

Grand Total All Awards = $971,053

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NEXT-GEN Oral test for monitoring HIV/AIDS in Point-of-Care

Award Number: R44DE021672

ORGANIZATION: NATIONAL INSTITUTE OF DENTAL AND CRANIOFACIAL RESEARCH

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 08/15/2011

PERIOD OF PERFORMANCE END DATE: 08/31/2019

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