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

商业化准备试点 (CRP) 计划支持： 用于直接从血液中识别血流感染的集成设备

• 批准号: 10583448
• 负责人: Alon Singer
• 金额: $ 100万
• 依托单位: HELIXBIND, INC.
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-03-03 至 2025-02-28
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10583448
• 关键词: Address; Adopted; Antimicrobial Resistance; Automation; Biological Assay; Blood; Breakthrough device; Budgets; Caring; Cessation of life; Clinic; Clinical; Clinical Microbiology; Clinical Research; Communicable Diseases; Complex; Computer software; Detection; Deterioration; Development; Devices; Diagnostic; Diagnostic Equipment; Early Diagnosis; Early treatment; Electronic Health Record; Engineering; Ensure; Exhibits; Feedback; Health Insurance Portability and Accountability Act; Hospitalization; Hospitals; Hour; Indiana; Infection; Injections; Intervention; Laboratories; Lead; Life; Marketing; Medical center; Methods; Mission; Molds; Molecular; National Institute of Allergy and Infectious Disease; Patient-Focused Outcomes; Patients; Phase; Preparation; Process; Quality of life; Resistance; Resistance development; Sampling; Sepsis; Septicemia; Small Business Innovation Research Grant; Specificity; Specimen; System; Technology; Temperature; Testing; Time; Universities; University Hospitals; Whole Blood; antimicrobial; assay development; commercialization; commercialization readiness; cost; cyber security; design; diagnostic strategy; experience; improved; institutional financing; instrument; instrumentation; manufacture; manufacturing capabilities; manufacturing scale-up; member; microbial; mortality; novel; novel diagnostics; pathogen; pathogenic bacteria; pathogenic fungus; patient prognosis; programs; resistance mechanism; response; success; systemic inflammatory response; timeline; tool; verification and validation

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.

项目总结