Phase I Amount
$1,000,000
Leading to over 270,000 deaths in the US annually, septicemia is the systemic inflammatory response to abloodstream infection (BSI). Early diagnosis and treatment of BSIs have demonstrated improved patientoutcomes and reduced hospitalization time. However, currently accepted diagnostic approaches have notadvanced 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 antimicrobialtreatment. There is therefore a significant need for new diagnostic approaches that do not require culture andprovide faster, more accurate results.To address this unmet need, HelixBind developed RaPID/BSI, a fully automated sample-to-answer test whichidentifies 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 priorantimicrobial treatment. Species level detail is provided with single CFUs/ml sensitivity, enabling selection ofappropriate antimicrobials. Commercialization of RaPID/BSI will provide timely characterization of BSIs andthus enable intervention with targeted antimicrobial treatment. This is expected to result in improved patientoutcomes 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 andquality 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 assayoptimization, automation of the assay onto a single-use plastic disposable operated by a benchtop instrumentand testing of clinical specimens. Clinical results demonstrating >94% sensitivity and 99.8% specificity acrossthe assay far surpassed our milestone of 90% sensitivity and 90% specificity. In addition, based on feedback frompotential customers, the test menu was expanded from 16 to 21 pathogens and the capability to detect resistancemechanisms was demonstrated.Given the success of Phase II, HelixBind proposes in this Commercialization Readiness Pilot program proposalto mature the manufacturing of the RaPID/BSI disposable; ensuring quality and sufficient scale to supportregulatory clearance and initial launch. In addition, this proposal will support the expansion of the RaPIDAnalyzer's software suite, addressing core issues as cyber security and connectivity to hospital Electronic HealthRecords in a HIPAA compliant manner. Upon completion of this project, we will be well placed to initiate formalAnalytical and Clinical studies for FDA clearance of RaPID/BSI.
Public Health Relevance Statement: PROJECT NARRATIVE
Sepsis, the body's response to a bloodstream infection, is often life-threatening. Timely administration of
appropriate antimicrobials is critical for successfully patient outcomes. However, current diagnostics for
identifying the infection, necessary for selection of the appropriate antimicrobial, require several days to
provide results. The proposed efforts described in this Commercialization Readiness Pilot program proposal
will advance the maturity of a novel, fully automated test capable of identifying and characterizing these
infections directly from blood in only a few hours. Success in this effort will result in a critically needed
diagnostic device, ready for manufacturing scale up as required for FDA trials and market launch.
Project Terms:
