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A peptide-based point-of-care vertical flow assay for the rapid diagnosis of Lyme disease

Award Number: R44AI150060
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: 06/24/2020
PERIOD OF PERFORMANCE END DATE: 06/30/2025

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A peptide-based point-of-care vertical flow assay for the rapid diagnosis of Lyme disease - Abstract Project Summary There is an obvious need for new approaches and better assays for the laboratory diagnosis of Lyme disease. All attempts to develop a practical assay for the direct detection of Borrelia burgdorferi in infected patients have failed. Thus far, all proposed alternatives to serology have been unsuccessful, not cost-effective, or are still in early development. Improving serological detection in early disease is the fastest and most effective way to improve patient outcomes in Lyme disease. The antigen targets utilized in current serodiagnostic assays have considerable defects. They often contain conserved epitopes that cross-react with antibodies raised to other antigens, reducing specificity and requiring the use of a two-tier seroassay paradigm that preserves specificity at the cost of poor sensitivity in the detection of early disease. The use of peptides as serodiagnostic targets demonstrate improved efficacy, but the use of one or two peptides containing single epitopes still provides re- duced sensitivity in early disease. Putting the same old antigen targets into new platforms, no matter how in- novative the platform, will not succeed in improving serodiagnostics for Lyme disease. Both the target anti- gens and assays need an innovative approach. By incorporating unique peptides containing linear epitopes highly specific to B. burgdorferi, into a cutting-edge, multiplex, portable paper-based point-of-care diagnostic assay that uses a cost-effective smartphone-based reader, we aim to transform the diagnosis of Lyme disease. An ideal test for Lyme disease could be performed in a single step and yield an answer on the spot to support diagnosis and direct the course of clinical treatment. We have developed an innovative vertical-flow assay which allows for the multiplexed detection of IgM and IgG binding of up to 25 independent antigen targets in a point-of-care setting. The VFA design allows for uniform flow of sample across the target membrane, creating uniform binding conditions and maximizing developed signal. We coupled this design with a cost-effective portable smart-phone based reader allowing for quantitative measure of antibody binding, eliminating subjectiv- ity. By multiplexing peptide antigens each containing 1-2 epitopes unique to B. burgdorferi from multiple differ- ent antigens expressed at different stages during mammalian infection we can generate a single tier, POC as- say that can specifically and sensitively detect patient antibody at all stages of the disease. The assay can be completed in less than 25 min allowing for rapid in office results to support clinical diagnosis, thereby improving patient outcomes.


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: 2025 ( Subtotal = $0 )
2025	2023	BIOPEPTIDES CORP	36 TOPSTONE RD	RIDGEFIELD	CT	06877	WESTERN CT	USA	Allergy and Infectious Diseases Research	000	4	8/28/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $971,240 )
2023	2023	BIOPEPTIDES CORP	18 WOODHULL RD	EAST SETAUKET	NY	11733	SUFFOLK	USA	Allergy and Infectious Diseases Research	000	4	7/5/2023	NON-COMPETING CONTINUATION	$971,240
														Subtotal = $971,240

Issue Date FY: 2022 ( Subtotal = $1,051,864 )
2022	2022	BIOPEPTIDES CORP	18 WOODHULL RD	EAST SETAUKET	NY	11733	SUFFOLK	USA	Allergy and Infectious Diseases Research	001	3	6/27/2022	NON-COMPETING CONTINUATION	$986,480
2022	2022	BIOPEPTIDES CORP	18 WOODHULL RD	EAST SETAUKET	NY	11733	SUFFOLK	USA	Allergy and Infectious Diseases Research	002	3	9/6/2022	SUPPLEMENT FOR EXPANSION	$65,384
2022	2020	BIOPEPTIDES CORP	18 WOODHULL RD	EAST SETAUKET	NY	11733	SUFFOLK	USA	Allergy and Infectious Diseases Research	000	1	2/7/2022	NEW	$0
														Subtotal = $1,051,864

Issue Date FY: 2021 ( Subtotal = $1,000,000 )
2021	2021	BIOPEPTIDES CORP	18 WOODHULL RD	EAST SETAUKET	NY	11733	SUFFOLK	USA	Allergy and Infectious Diseases Research	000	2	7/16/2021	EXTENSION WITH OR WITHOUT FUNDS	$1,000,000
														Subtotal = $1,000,000

Issue Date FY: 2020 ( Subtotal = $300,000 )
2020	2020	BIOPEPTIDES CORP	18 WOODHULL RD	EAST SETAUKET	NY	11733	SUFFOLK	USA	Allergy and Infectious Diseases Research	000	1	6/24/2020	NEW	$300,000
														Subtotal = $300,000

Grand Total All Awards = $3,323,104

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A peptide-based point-of-care vertical flow assay for the rapid diagnosis of Lyme disease

Award Number: R44AI150060

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: 06/24/2020

PERIOD OF PERFORMANCE END DATE: 06/30/2025

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