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Commercialization Readiness Pilot (CRP) program support for: An Integrated Device for identification of bloodstream infections directly from blood

Award Number: SB1AI172427
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: 03/03/2022
PERIOD OF PERFORMANCE END DATE: 02/28/2026

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Commercialization Readiness Pilot (CRP) program support for: An Integrated Device for identification of bloodstream infections directly from blood - PROJECT SUMMARY Leading to over 270,000 deaths in the US annually, septicemia is the systemic inflammatory response to a bloodstream infection (BSI). Early diagnosis and treatment of BSIs have demonstrated improved patient outcomes and reduced hospitalization time. However, currently accepted diagnostic approaches have not advanced substantially since the advent of automated blood culturing systems. As such, today’s gold-standard, is not only slow, requiring ~1-3 days, but also demonstrates reduced sensitivity in the presence of antimicrobial treatment. 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/BSI, a fully automated sample-to-answer test which identifies and characterizes BSIs 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/BSI incorporates a broad test menu of 21 bacterial and fungal pathogens and is not compromised by prior antimicrobial treatment. Species level detail is provided with single CFUs/ml sensitivity, enabling selection of appropriate antimicrobials. Commercialization of RaPID/BSI will provide timely characterization of BSIs 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. Reflecting RaPID/BSI’s significant advantages over exiting alternatives and the potential to improve care and quality of life, the FDA designated RaPID/BSI a Breakthrough Technology in 2020. HelixBind has met and exceeded all of the Specific Aims defined in the Phase II SBIR. This included assay optimization, automation of the assay onto a single-use plastic disposable operated by a benchtop instrument and testing of clinical specimens. Clinical results demonstrating >94% sensitivity and 99.8% specificity across the assay far surpassed our milestone of 90% sensitivity and 90% specificity. In addition, based on feedback from potential customers, the test menu was expanded from 16 to 21 pathogens and the capability to detect resistance mechanisms was demonstrated. Given the success of Phase II, HelixBind proposes in this Commercialization Readiness Pilot program proposal to mature the manufacturing of the RaPID/BSI disposable; ensuring quality and sufficient scale to support regulatory clearance and initial launch. In addition, this proposal will support the expansion of the RaPID Analyzer’s software suite, addressing core issues as cyber security and connectivity to hospital Electronic Health Records in a HIPAA compliant manner. Upon completion of this project, we will be well placed to initiate formal Analytical and Clinical studies for FDA clearance of RaPID/BSI.


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: 2024 ( Subtotal = $1,000,000 )
2024	2024	HELIXBIND, INC.	1300 MASSACHUSETTS AVE	BOXBOROUGH	MA	01719	MIDDLESEX	USA	Allergy and Infectious Diseases Research	000	3	3/1/2024	NON-COMPETING CONTINUATION	$1,000,000
														Subtotal = $1,000,000

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	2	2/24/2023	NON-COMPETING CONTINUATION	$1,000,000
														Subtotal = $1,000,000

Issue Date FY: 2022 ( Subtotal = $1,000,000 )
2022	2022	HELIXBIND INC.	181 CEDAR HILL ST STE 1	MARLBOROUGH	MA	01752	MIDDLESEX	USA	Allergy and Infectious Diseases Research	000	1	3/3/2022	NEW	$1,000,000
														Subtotal = $1,000,000

Grand Total All Awards = $3,000,000

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Commercialization Readiness Pilot (CRP) program support for: An Integrated Device for identification of bloodstream infections directly from blood

Award Number: SB1AI172427

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: 03/03/2022

PERIOD OF PERFORMANCE END DATE: 02/28/2026

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