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

项目摘要 败血症每年在美国导致超过270，000人死亡，败血症是对急性炎症的全身性炎症反应。 血液感染（BSI）。BSI的早期诊断和治疗已证明患者 结果和减少住院时间。然而，目前公认的诊断方法还没有 自自动化血液培养系统出现以来，因此，今天的金本位制， 不仅缓慢，需要约1-3天，而且在抗菌剂存在下显示出降低的敏感性。 治疗因此，非常需要新的诊断方法，不需要培养， 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，这是一种全自动的样本到答案测试， 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 （耐药性和病原体鉴定）平台，并适合在整个医院放置， RaPID/BSI包含了21种细菌和真菌病原体的广泛测试菜单，并且不会受到先前测试的影响。 抗菌处理提供了单个CFU/ml灵敏度的种属级别详细信息， 适当的抗菌剂。RaPID/BSI的商业化将提供BSI的及时表征， 从而能够用靶向抗菌治疗进行干预。预计这将改善患者 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。 反映了RaPID/BSI相对于现有替代品的显著优势以及改善护理和 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。这包括含量测定 优化、自动化检测，使用台式仪器操作一次性塑料 和临床标本的检测。临床结果表明，在所有受试者中，灵敏度>94%，特异性> 99.8%。 该分析远远超过了我们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种扩大到21种病原体，并能够检测耐药性 机制得到证实。 鉴于第二阶段的成功，HelixBind在商业化准备试点计划提案中提出 成熟RaPID/BSI一次性用品的生产;确保质量和足够的规模，以支持 监管许可和首次发布。此外，该提案还将支持扩大RaPID， 分析仪的软件套件，解决网络安全和连接到医院电子健康的核心问题 以符合HIPAA的方式进行记录。在这个项目完成后，我们将很好地启动正式的 FDA批准RaPID/BSI的分析和临床研究。

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.