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Immunoassay for diagnosis of Babesia infection

Award Number: R44AI100471
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: 12/15/2012
PERIOD OF PERFORMANCE END DATE: 10/31/2017

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Immunoassay for diagnosis of Babesia infection - DESCRIPTION (provided by applicant): In this Phase II project, development and clinical validation of an ELISA test for in vitro diagnosis of Babesia microti infection will be completed. Babesiosis is an emerging tick-borne parasitic disease which may cause severe to fatal illness in immunocompromised or otherwise weakened patients, and may be carried in the blood subclinically in up to 1% of the population in endemic areas. Recent cases of fatal transfusion- transmitted babesiosis have also led to the identification of this pathogen as a significant threat to the blood supply. However, currently no commercial, validated and FDA approved tests are available for B. microti. Babesiosis is currently diagnosed by immunofluorescence staining, microscopy of blood smears, and/or PCR. None of these procedures are easily adaptable to routine clinical laboratory use. In Phase I, we developed a microplate-based ELISA using a mixture of 5 novel synthetic B. microti peptide antigens comprising 6 immunodominant epitopes that were demonstrated to be diagnostically significant markers of infection. The five peptide sequences were identified through screening of libraries of overlapping peptides derived from members of the BMN1 family of B. microti proteins, a group previously identified as highly immunoreactive, against babesiosis patient sera. Several of these peptides and epitopes have not previously been recognized as immunodominant, and represent new discoveries. Sensitivity of 100% among 60 confirmed babesiosis cases was achieved, along with specificity above 99.5% in low-risk blood donors and other controls. The 5 peptides have been combined in a single well ELISA format using an innovative immobilization chemistry. The prototype ELISA will be optimized with respect to peptide stoichiometry and all other assay parameters and scaled up for manufacturing in Phase II. To validate assay performance, a clinical study will be carried out in Phase II, in which the B. microti ELISA will be compared with PCR and blood smear, which are considered gold standard assays for Babesia infection. A retrospective clinical study will evaluate assay performance on well-characterized samples from confirmed babesiosis cases, while a prospective study will examine undiagnosed patients seen at tick-borne disease clinics at three medical centers in regions of the Northeast and Midwest that are highly endemic for B. microti. The clinical study will determine the performance of the B. microti ELISA vs. PCR, blood smear and immunofluorescence for diagnosis of B. microti infection. Results will be submitted in a 510(k) application to FDA for clearance of the B. microti ELISA for in vitro diagnostic use.


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: 2023 ( Subtotal = $0 )
2023	2016	IMMUNETICS, INC.	27 DRYDOCK AVE STE 12	BOSTON	MA	02210	SUFFOLK	USA	Allergy and Infectious Diseases Research	000	4	9/7/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2019 ( Subtotal = -$539,901 )
2019	2016	IMMUNETICS, INC.	27 DRYDOCK AVE STE 12	BOSTON	MA	02210	SUFFOLK	USA	Allergy and Infectious Diseases Research	000	4	3/14/2019	NON-COMPETING CONTINUATION	-$539,901
														Subtotal = -$539,901

Issue Date FY: 2018 ( Subtotal = $0 )
2018	2016	IMMUNETICS, INC.	27 DRYDOCK AVE STE 12	BOSTON	MA	02210	SUFFOLK	USA	Allergy and Infectious Diseases Research	000	4	12/15/2017	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2016 ( Subtotal = $808,595 )
2016	2016	IMMUNETICS, INC	27 DRYDOCK AVE	BOSTON	MA	02210	SUFFOLK	USA	Allergy and Infectious Diseases Research	000	4	6/2/2016	NON-COMPETING CONTINUATION	$808,595
														Subtotal = $808,595

Issue Date FY: 2015 ( Subtotal = $808,595 )
2015	2015	IMMUNETICS, INC	27 DRYDOCK AVE	BOSTON	MA	02210	SUFFOLK	USA	Allergy and Infectious Diseases Research	000	3	6/10/2015	COMPETING CONTINUATION	$808,595
														Subtotal = $808,595

Grand Total All Awards = $1,077,289

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Immunoassay for diagnosis of Babesia infection

Award Number: R44AI100471

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: 12/15/2012

PERIOD OF PERFORMANCE END DATE: 10/31/2017

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