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 败血症在美国每年导致超过27万人死亡，败血症是对 血流感染(BSI)。BSI的早期诊断和治疗显示患者病情有所改善 结果和减少住院时间。然而，目前被接受的诊断方法还没有 自从自动化血液培养系统问世以来，这一技术有了很大的进步。因此，今天的黄金标准， 不仅反应缓慢，需要大约1-3天，而且在存在抗菌剂的情况下也表现出敏感性降低 治疗。因此，非常需要新的诊断方法，这些方法不需要文化和 提供更快、更准确的结果。 为了解决这一未得到满足的需求，HelixBind开发了RAPID/BSI，这是一种完全自动化的样本到答案测试， 直接从血液中鉴定和鉴定BSI只需约3小时，无需培养。以快速的速度实施 (抗药性和病原体鉴定)平台，适合在医院内放置， RAPID/BSI包含21种细菌和真菌病原体的广泛测试菜单，不会受到之前 抗菌治疗。物种级别的详细信息具有单一CFU/ml的灵敏度，使您能够选择 适当的抗菌剂。RAPID/BSI的商业化将及时提供BSI的特征和 从而能够通过有针对性的抗微生物治疗进行干预。这有望改善患者的病情 结果和减少不必要的抗菌剂的使用，减缓了抗菌素耐药性的上升。 反映了快速/BSI相对于现有替代方案的显著优势以及改善护理和 为了提高生活质量，FDA在2020年将RAPID/BSI指定为突破性技术。 HelixBind已经达到并超过了第二阶段SBIR中定义的所有具体目标。这包括化验 由台式仪器操作的一次性塑料一次性测试的优化、自动化 以及临床标本的检测。临床结果显示&gt；94%的敏感性和99.8%的特异性 这项检测远远超过了我们90%的敏感性和90%的特异性的里程碑。此外，根据来自以下方面的反馈 潜在客户，测试菜单从16种病原体扩大到21种，并具有检测耐药性的能力 对其作用机理进行了论证。 鉴于第二阶段的成功，HelixBind在此商业化准备试点计划中提出了建议 成熟快速/BSI一次性产品的制造；确保质量和足够的规模以支持 监管审批和初步推出。此外，这项建议还将支持快速扩容 Analyzer的软件套件，解决了网络安全和医院电子健康连接等核心问题 以符合HIPAA的方式进行记录。在这个项目完成后，我们将处于有利地位，启动正式 FDA清除RAPID/BSI的分析和临床研究。