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Direct-from-specimen identification of pathogens common in endocarditis

Award Number: R44AI136064
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: 01/04/2018
PERIOD OF PERFORMANCE END DATE: 12/31/2026

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Direct-from-specimen identification of pathogens common in endocarditis - PROJECT SUMMARY Infective Endocarditis (IE) occurs when bacteria or fungi adhere to the endocardial surface forming small lesions. This invasive disease is characterized by a mortality rate exceeding 25%, is associated with extended hospitalization, and often impairs the quality of life for those who survive. Early microbial diagnosis and antimicrobial intervention are crucial to improved patient outcomes and reduced hospitalization time. However, currently accepted diagnostic approaches still rely on primary blood culture, which exhibits long and variable turnaround times and are prone to false-negative results. There is therefore a significant need for new diagnostic approaches that do not require culture and provide faster, more accurate results. To address this unmet need, HelixBind developed RaPID/IE, a fully automated sample-to-answer test which identifies and characterizes these infections directly from blood in ~3 hours, without cultures. Implemented on the RaPID (Resistance and Pathogen IDentification) platform and appropriate for placement throughout the hospital, RaPID/IE incorporates a broad test menu including both bacterial and fungal pathogens, as well as a marker of antimicrobial resistance. Crucially, the test is not compromised by prior antimicrobial treatment and provides species level detail with single CFUs/ml sensitivity, enabling selection of appropriate antimicrobials. Commercialization of RaPID/IE will provide timely identification and characterization of the invasive agent and thus enable intervention with targeted antimicrobial treatment. This is expected to result in improved patient outcomes and a reduction in the use of unnecessary antimicrobials, slowing the rise of antimicrobial resistance. HelixBind has met and exceeded all the Specific Aims defined in the Phase II SBIR. This included menu expansion to cover antibiotic resistance as well as pathogens associated with IE which cannot be recovered by clinical cultures, automation of the assay onto single-use disposables operated by a benchtop instrument, and successful completion of a preliminary clinical study. In addition, and based on feedback from potential customers, the menu was expanded further to include coverage of pathogens associated with conditions sharing symptoms with IE. Additional analytical testing was performed to ensure the assay meets product specifications. In this proposed Phase IIB, HelixBind will build on our success in Phase II to advance RaPID/IE by addressing potential risks associated with direct from blood detection of antimicrobial resistance, increasing the product’s room-temperature shelf life, and completing a prospective clinical study on-site at a partner hospital. Upon completion of this project, we will be well placed to initiate analytical and clinical studies for FDA premarket notification and clearance of RaPID/IE.


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 = $1,049,999 )
2025	2025	HELIXBIND, INC.	1300 MASSACHUSETTS AVE	BOXBOROUGH	MA	01719	MIDDLESEX	USA	Allergy and Infectious Diseases Research	000	6	12/12/2024	NON-COMPETING CONTINUATION	$1,049,999
														Subtotal = $1,049,999

Issue Date FY: 2024 ( Subtotal = $1,001,029 )
2024	2024	HELIXBIND, INC.	1300 MASSACHUSETTS AVE	BOXBOROUGH	MA	01719	MIDDLESEX	USA	Allergy and Infectious Diseases Research	001	5	1/19/2024	COMPETING CONTINUATION	$1,001,029
2024	2021	HELIXBIND, INC.	1300 MASSACHUSETTS AVE	BOXBOROUGH	MA	01719	MIDDLESEX	USA	Allergy and Infectious Diseases Research	000	4	1/9/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $1,001,029

Issue Date FY: 2021 ( Subtotal = $1,000,000 )
2021	2021	HELIXBIND INC.	181 CEDAR HILL ST STE 1	MARLBOROUGH	MA	01752	MIDDLESEX	USA	Allergy and Infectious Diseases Research	000	4	12/17/2020	NON-COMPETING CONTINUATION	$1,000,000
														Subtotal = $1,000,000

Issue Date FY: 2020 ( Subtotal = $1,003,905 )
2020	2020	HELIXBIND INC.	181 CEDAR HILL ST STE 1	MARLBOROUGH	MA	01752	MIDDLESEX	USA	Allergy and Infectious Diseases Research	001	3	1/3/2020	NON-COMPETING CONTINUATION	$998,005
2020	2019	HELIXBIND INC.	181 CEDAR HILL ST STE 1	MARLBOROUGH	MA	01752	MIDDLESEX	USA	Allergy and Infectious Diseases Research	000	2	11/5/2019	COMPETING CONTINUATION	$5,900
														Subtotal = $1,003,905

Issue Date FY: 2019 ( Subtotal = $1,000,000 )
2019	2019	HELIXBIND INC.	181 CEDAR HILL ST STE 1	MARLBOROUGH	MA	01752	MIDDLESEX	USA	Allergy and Infectious Diseases Research	000	2	12/19/2018	COMPETING CONTINUATION	$1,000,000
														Subtotal = $1,000,000

Grand Total All Awards = $5,054,933

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Direct-from-specimen identification of pathogens common in endocarditis

Award Number: R44AI136064

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: 01/04/2018

PERIOD OF PERFORMANCE END DATE: 12/31/2026

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