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Point-of-care Detection of HIV Antibodies and RNA in Blood and Saliva

Award Number: R44DE024456
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: 04/02/2014
PERIOD OF PERFORMANCE END DATE: 06/30/2018

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Point-of-care Detection of HIV Antibodies and RNA in Blood and Saliva - DESCRIPTION (provided by applicant): The global HIV/AIDS epidemic continues to be fueled by the large number of individuals who do not know that they are infected. The CDC is supporting programs to decrease this number by encouraging more frequent testing of all age groups as well as increasing the venues for testing including the recent FDA approval of an oral HIV Screening test for anti-HIV antibodies. That said, a reactive (i.e., positive) test still requies a confirmatory test that often requires a second visit to a health professional. Additionally, ther is a "seroconversion" window of many weeks from the time of infection until antibodies to the virus can be detected. In this interval HIV viral loads are at their highest levels, increasing the chance for transmission to other individuals. Over the past several years, Rheonix Inc. and NYU have been collaborating on a novel point-of-care device to simultaneously detect both anti-HIV antibodies and viral nucleic acid in less than 1 hour. Starting with a drop of blood or a saliva sample, we have been able to combine a screening test (antibody) using lateral flow with a confirmatory molecular test for viral RNA utilizing isothermal amplification (LAMP). Employing Rheonix's patented technology, the device being developed utilizes a microfluidic-based disposable CARD" that can be simply operated with the push of a button to provide a yes/no result for both antibody and nucleic acid in less than 60 minutes on a device that is portable and practical for both small clinics or field use. The results from the present fast-track SBIR proposa will complete the development of this dual pathway device in 2 years utilizing our preliminary data on all aspects of this innovative approach. The impact of the dual pathway point-of-care approach will permit a "test and treat" program to rapidly identify infected individuals and accelerate their treatment, ultimately decreasing the viral burden in a community.


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: 2019 ( Subtotal = $0 )
2019	2016	RHEONIX, INC.	10 BROWN RD, STE 103	ITHACA	NY	14850	TOMPKINS	USA	Oral Diseases and Disorders Research	000	3	11/29/2018	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2017 ( Subtotal = $0 )
2017	2016	RHEONIX, INC.	10 BROWN RD, STE 103	ITHACA	NY	14850	TOMPKINS	USA	Oral Diseases and Disorders Research	000	3	3/23/2017	NON-COMPETING CONTINUATION	$0
2017	2016	RHEONIX, INC.	10 BROWN RD, STE 103	ITHACA	NY	14850	TOMPKINS	USA	Oral Diseases and Disorders Research	001	3	3/23/2017	SUPPLEMENT FOR EXPANSION	$0
														Subtotal = $0

Issue Date FY: 2016 ( Subtotal = $1,152,536 )
2016	2016	RHEONIX INC	22 THORNWOOD DRIVE	ITHACA	NY	14850	TOMPKINS	USA	Oral Diseases and Disorders Research	000	3	12/4/2015	NON-COMPETING CONTINUATION	$496,122
2016	2016	RHEONIX INC	22 THORNWOOD DRIVE	ITHACA	NY	14850	TOMPKINS	USA	Oral Diseases and Disorders Research	001	3	3/16/2016	NON-COMPETING CONTINUATION	$0
2016	2016	RHEONIX INC	22 THORNWOOD DRIVE	ITHACA	NY	14850	TOMPKINS	USA	Oral Diseases and Disorders Research	002	3	3/31/2016	SUPPLEMENT FOR EXPANSION	$656,414
														Subtotal = $1,152,536

Issue Date FY: 2015 ( Subtotal = $998,469 )
2015	2015	RHEONIX INC	22 THORNWOOD DRIVE	ITHACA	NY	14850	TOMPKINS	USA	Oral Diseases and Disorders Research	000	2	1/23/2015	EXTENSION WITH OR WITHOUT FUNDS	$998,469
														Subtotal = $998,469

Issue Date FY: 2014 ( Subtotal = $189,646 )
2014	2014	RHEONIX INC	22 THORNWOOD DRIVE	ITHACA	NY	14850	TOMPKINS	USA	Oral Diseases and Disorders Research	000	1	4/1/2014	NEW	$189,646
														Subtotal = $189,646

Grand Total All Awards = $2,340,651

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Point-of-care Detection of HIV Antibodies and RNA in Blood and Saliva

Award Number: R44DE024456

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: 04/02/2014

PERIOD OF PERFORMANCE END DATE: 06/30/2018

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