Rapid Identification of Pathogenic Bacteria in Blood causing Sepsis

脓毒症是美国医院死亡的主要原因，占全美总数的52% 医院死亡，是美国医院治疗费用最高的疾病，花费超过17美元 每年10亿美元。每年生产3亿多瓶血培养瓶，有市场 仅在美国和欧盟的规模就超过12亿美元。 第二阶段为期两年，从2013年2月到2015年2月(5 R44 AI094781-03)。这个 部分由这笔赠款资助的研究已经创造了一种诊断血液流动的新范式 感染导致败血症。这笔赠款的工作帮助创建了SPECID血液文化 系统，该公司目前正在将其商业化。SPECID解决方案取代了目前的3步 表征血液样本的过程，目前分为1)感染检测；2) 由训练有素的技术人员在工作台上进行所有阳性培养的强制性革兰氏染色； 然后3)MALDI-TOF的物种ID，(同样需要熟练的样品制备)，SPECID 与台式机相比，该解决方案结合了更快的检测速度、更准确的Gram状态确定 染色，ID比MALDI更准确，在单一的全自动步骤中，减少了 ID，简化了实验室工作流程，并节省了大量成本。其结果是改善了患者的预后 和改进的实验室操作性能。 此商业化准备试点(CRP)计划提案的目标反映了关键 没有得到第二阶段或第二阶段B计划支持，但需要实现商业目标 SPECID血液培养系统的市场准入包括：血液培养介质的开发 制造流程、质量控制和文件系统的开发、FDA战略以 实现SPECID血培养仪器和血培养的510(K)认证和开发 瓶子传感器附件。

Sepsis is the leading cause of deaths in US hospitals contributing to or causing 52% of all US hospital deaths and is the most expensive condition treated in US hospitals, costing more than $17 billion annually. More than 300 million blood culture bottles are produced annually, with a market size greater than $1.2B in the US and EU alone. The two-year phase II period spanned February 2013 to February 2015 (5 R44 AI094781-03). The developments, funded in part by this grant, have created a new paradigm to diagnose blood stream infection causing sepsis. The work of this grant has assisted in creating the SpecID blood culture system, which the company is now commercializing. The SpecID solution replaces the present 3-step process for characterization of blood samples, currently divided into 1) detection of infection; 2) an obligatory Gram stain for all positive cultures performed on the bench by trained technician; and then 3) species ID by MALDI-TOF, (again requiring skilled sample preparation), The SpecID solution combines faster detection, more accurate Gram status determination than the benchtop stain, and ID more accurate than MALDI, in a single fully automated step which reduces the time to ID, streamlines lab workflow, and saves significant cost. The result is improved patient outcomes and improved lab operating performance. The objectives of this Commercialization Readiness Pilot (CRP) Program proposal reflect the key goals not supported by the Phase II or Phase IIB programs but required to achieve commercial market entry of the SpecID blood culture system including: development of blood culture media manufacturing processes, development of quality control and documentation systems, FDA strategy to achieve 510(k) approval and development of the SpecID blood culture instrument and blood culture bottle sensor attachment.