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.
