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Commercialization Readiness Pilot (CRP) program support for: Direct-from-specimen identification of pathogens common in endocarditis

Award Number: SB1AI172440
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: 06/20/2023
PERIOD OF PERFORMANCE END DATE: 05/31/2027

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Commercialization Readiness Pilot (CRP) program support for: 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 can provide 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 testing of clinical specimens. Clinical results demonstrate a sensitivity and specificity of 92.7% and 98.8%, respectively. In addition, based on feedback from potential customers, the test menu was expanded further to include coverage of pathogens associated with conditions sharing symptoms with IE. The disposable and instrument were transitioned to manufacturing and extensive analytical testing was performed to ensure the assay meets specifications associated with regulatory and market requirements. In this CRP program, HelixBind will build on our success in Phase II to prepare for regulatory clearance and market launch. This includes (1) development of analytical methods, based on FDA feedback, required to successfully complete analytical and clinical validation studies; and (2) development of scalable manufacturing processes for certain reagent sets to ensure 12-month, room temperature stability, of tests cassettes, and (3) completion of an on-site analytical evaluation and blinded, clinical assessment study. Upon completion of this project, we will be well placed to initiate formal analytical and clinical studies for FDA 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: 2026 ( Subtotal = $0 )
2026	2025	HELIXBIND, INC.	1300 MASSACHUSETTS AVE	BOXBOROUGH	MA	01719	MIDDLESEX	USA	Allergy and Infectious Diseases Research	000	3	3/2/2026	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2025 ( Subtotal = $1,000,000 )
2025	2025	HELIXBIND, INC.	1300 MASSACHUSETTS AVE	BOXBOROUGH	MA	01719	MIDDLESEX	USA	Allergy and Infectious Diseases Research	000	3	6/11/2025	NON-COMPETING CONTINUATION	$1,000,000
														Subtotal = $1,000,000

Issue Date FY: 2024 ( Subtotal = $997,234 )
2024	2024	HELIXBIND, INC.	1300 MASSACHUSETTS AVE	BOXBOROUGH	MA	01719	MIDDLESEX	USA	Allergy and Infectious Diseases Research	000	2	5/23/2024	NON-COMPETING CONTINUATION	$997,234
														Subtotal = $997,234

Issue Date FY: 2023 ( Subtotal = $1,000,000 )
2023	2023	HELIXBIND INC	1300 MASSACHUSETTS AVE	BOXBOROUGH	MA	01719	MIDDLESEX	USA	Allergy and Infectious Diseases Research	000	1	6/20/2023	NEW	$1,000,000
														Subtotal = $1,000,000

Grand Total All Awards = $2,997,234

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Commercialization Readiness Pilot (CRP) program support for: Direct-from-specimen identification of pathogens common in endocarditis

Award Number: SB1AI172440

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: 06/20/2023

PERIOD OF PERFORMANCE END DATE: 05/31/2027

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