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LAB ON A CHIP POINT OF CARE ASSAY FOR THE RAPID SERODIAGNOSIS OF LYME DISEASE

Award Number: R43AI096551
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: 09/03/2011
PERIOD OF PERFORMANCE END DATE: 02/28/2014

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LAB ON A CHIP POINT OF CARE ASSAY FOR THE RAPID SERODIAGNOSIS OF LYME DISEASE - DESCRIPTION (provided by applicant): Caused by Borrelia burgdorferi, Lyme Disease (LD) can affect the skin, heart, joints or nervous system leading to an array of symptoms that overlap with those of other illnesses. LD is the most common vector-borne infectious disease in the United States and remains a significant public health concern. Early diagnosis and treatment is key to improving disease outcome. The laboratory diagnosis of LD depends on the demonstration of antibodies against Borrelia burgdorferi. There are few rapid point-of-care assays in the market based on lab-on-a-chip technology and none has been developed for LD. Further, current assays are poorly sensitive especially in early disease and cannot discriminate between the early and late stages of LD. New assays are needed and we plan to fill this unmet need. In this Phase I proposal our main objective is to use ultrasensitive microfluidics technology to develop and assess the performance of a rapid lab-on-a-chip, multi-antigenic, stage-specific, and quantitative Point-Of-Care (POC) assay for the serodiagnosis of Lyme disease (LD). After establishing the proof-of-concept of a lab-on-a-chip prototype first-tier Lyme disease test, we plan to move it towards commercialization in Phase II in partnership with Claros Diagnostics. This company specializes in transitioning technology from the laboratory to the physician's office or bedside and has recently received regulatory approval for a point-of-care system in Europe. A rapid, stage-specific assay for the serodiagnosis of Lyme disease is a much sought after device that will advance diagnostic testing beyond the current state of the art. PUBLIC HEALTH RELEVANCE: Lyme disease, the most common vector-borne infectious disease in the United States affects multiple organ systems. Although prompt diagnosis and treatment prevents or limits serious injury to the systems affected, current sero-diagnostics for Lyme disease lack sensitivity in early disease. Furthermore, there is no rapid point-of-care assay in the market based on lab-on-a-chip technology for Lyme disease. Our objective is to develop a novel front-line diagnostic testing device that enables simultaneous detection of multiple Borrelia burgdorferi antigens at the point of care. It is a quantitative rapid assay for serodiagnosis of Lyme disease that has the additional benefit of distinguishing between the stages of the disease. This low-cost portable device requires just one small finger-pricked volume of blood, and performs diagnostic testing that is as accurate as laboratory testing.


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: 2013 ( Subtotal = $0 )
2013	2012	BIOPEPTIDES INC	25 EAST LOOP ROAD	STONY BROOK	NY	11790	SUFFOLK	USA	Allergy and Infectious Diseases Research	000	2	9/19/2013	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2012 ( Subtotal = $300,000 )
2012	2012	BIOPEPTIDES INC	25 EAST LOOP ROAD	STONY BROOK	NY	11790	SUFFOLK	USA	Allergy and Infectious Diseases Research	000	2	8/2/2012	NON-COMPETING CONTINUATION	$300,000
														Subtotal = $300,000

Issue Date FY: 2011 ( Subtotal = $300,000 )
2011	2011	BIOPEPTIDES INC	25 EAST LOOP ROAD	STONY BROOK	NY	11790	SUFFOLK	USA	Allergy and Infectious Diseases Research	001	1	9/19/2011	NEW	$0
2011	2011	BIOPEPTIDES INC	25 EAST LOOP ROAD	STONY BROOK	NY	11790	SUFFOLK	USA	Allergy and Infectious Diseases Research	000	1	9/6/2011	NEW	$300,000
														Subtotal = $300,000

Grand Total All Awards = $600,000

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LAB ON A CHIP POINT OF CARE ASSAY FOR THE RAPID SERODIAGNOSIS OF LYME DISEASE

Award Number: R43AI096551

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: 09/03/2011

PERIOD OF PERFORMANCE END DATE: 02/28/2014

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