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.

项目概要 败血症是一种全身炎症反应，每年在美国导致超过 270,000 人死亡 血流感染（BSI）。 BSI 的早期诊断和治疗已证明患者病情有所改善 结果并减少住院时间。然而，目前公认的诊断方法尚未 自从自动化血液培养系统出现以来，技术取得了长足的进步。因此，今天的黄金标准， 不仅缓慢，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，迫切需要不需要培养和检测的新诊断方法。 提供更快、更准确的结果。 为了解决这一未满足的需求，HelixBind 开发了 RaPID/BSI，这是一种全自动样本到答案测试， 在约 3 小时内直接从血液中识别和表征 BSI，无需培养。在 RaPID 上实施 （耐药性和病原体识别）平台，适合放置在整个医院， RaPID/BSI 包含 21 种细​​菌和真菌病原体的广泛测试菜单，并且不受先前测试的影响 抗菌治疗。物种水平详细信息以单 CFU/ml 灵敏度提供，从而可以选择 适当的抗菌药物。 RaPID/BSI 的商业化将提供 BSI 的及时表征和 从而能够进行有针对性的抗菌治疗干预。预计这将改善患者的病情 成果并减少不必要的抗菌药物的使用，减缓抗菌药物耐药性的上升。 反映 RaPID/BSI 相对于现有替代方案的显着优势以及改善护理和治疗的潜力 生活质量，FDA 于 2020 年将 RaPID/BSI 指定为突破性技术。 HelixBind 已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用品上的优化、自动化测定 以及临床标本的检测。临床结果显示 >94% 的敏感性和 99.8% 的特异性 该检测方法远远超过了我们 90% 灵敏度和 90% 特异性的里程碑。此外，根据反馈 针对潜在客户，测试菜单从 16 种病原体扩展到 21 种病原体，并具有检测耐药性的能力 机制得到了论证。 鉴于第二阶段的成功，HelixBind 在此商业化准备试点计划提案中提出 成熟 RaPID/BSI 一次性产品的制造；确保质量和足够的规模来支持 监管审批和初步启动。此外，该提案将支持 RaPID 的扩展 分析器的软件套件，解决网络安全和与医院电子健康连接等核心问题 以符合 HIPAA 的方式进行记录。该项目完成后，我们将能够启动正式的 FDA 批准 RaPID/BSI 的分析和临床研究。