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.

项目摘要 每年在美国导致超过270,000人死亡，败血病是对A的全身性炎症反应 血液感染（BSI）。 BSI的早期诊断和治疗表现出改善的患者 结局和减少住院时间。但是，目前接受的诊断方法尚未 自自动血液培养系统的发展以来，大大提高了。因此，今天的黄金标准 不仅需要约1-3天，而且还表现出抗菌素存在下的灵敏度降低 治疗。因此，不需要文化的新诊断方法非常需要 提供更快，更准确的结果。 为了满足这种未满足的需求，HelixBind开发了Rapid/bsi，这是一种全自动的样本到答案测试 在没有培养的情况下，在〜3小时内直接从血液中识别和表征BSI。快速实施 （电阻和病原体识别）平台，适合在整个医院安置， Rapid/BSI包含21种细菌和真菌病原体的广泛测试菜单，并未受到先验的损害 抗菌治疗。物种级别的细节具有单一的CFU/ML灵敏度，从而选择了 适当的抗菌剂。快速/BSI的商业化将及时地表征BSI和 这预计会改善患者 结果和减少不必要的抗菌药物的使用，从而减慢了抗菌耐药性的升高。 反映了快速/BSI在退出替代方案方面具有重要优势，以及改善护理和 生活质量，FDA在2020年将Rapid/BSI指定为突破性技术。 Helixbind已经满足并超过了II期SBIR中定义的所有特定目标。这包括测定 优化，测定自动化在台式仪器操作的一次性塑料一次性上 和临床标本的测试。临床结果表明敏感性> 94％和99.8％的特异性 该测定法超过了我们90％灵敏度和90％特异性的里程碑。此外，根据来自 潜在客户，测试菜单从16个病原体扩展到2​​1个病原体，并且能够检测阻力 证明了机制。 鉴于第二阶段的成功，此商业化准备飞行员计划提案中的Helixbind提案提案 成熟快速/BSI一次性的制造；确保质量和足够的规模支持 监管间隙和初始发布。此外，该建议将支持快速的扩展 Analyzer的软件套件，解决了网络安全性和与医院电子健康的连通性有关的核心问题 以HIPAA符合HIPAA的方式记录。该项目完成后，我们将很适合启动表格 FDA清除快速/BSI的分析和临床研究。