Rapid Identification of Pathogenic Bacteria in Blood causing Sepsis

快速鉴定血液中引起败血症的病原菌

• 批准号: 9335244
• 负责人: Ray Anthony Martino
• 金额: $ 99.67万
• 依托单位: ISENSE, LLC
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-03-15 至 2019-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9335244
• 关键词: Blood; Blood specimen; Cause of Death; Cessation of life; Clinical Trials; Computer software; Culture Media; Detection; Development; Devices; Diagnosis; Documentation; Ensure; Funding; Goals; Grant; Healthcare Systems; Hospital Costs; Hospitals; Infection; Molecular Probes; Patient-Focused Outcomes; Performance; Phase; Preparation; Process; Quality Control; Readiness; Sampling; Sensory; Sepsis; Spectrometry, Mass, Matrix-Assisted Laser Desorption-Ionization; Staining method; Stains; Stream; System; Time; Training; Work; base; commercialization; cost; design; effective therapy; improved; instrument; manufacturing process development; new technology; operation; pathogenic bacteria; programs; routine Bacterial stain; sensor; verification and validation

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.

脓毒症是美国医院死亡的主要原因，导致美国 52% 的医院死亡 医院死亡，是美国医院治疗最昂贵的疾病，费用超过 17 美元 每年亿。年产血培养瓶3亿余只，市场广阔 仅在美国和欧盟，规模就超过 $1.2B。 第二阶段为期两年，涵盖 2013 年 2 月至 2015 年 2 月 (5 R44 AI094781-03)。这 由这笔赠款部分资助的发展创造了诊断血流的新范例 感染引起败血症。这笔赠款的工作有助于创建 SpecID 血培养 系统，该公司目前正在将其商业化。 SpecID 解决方案取代了当前的 3 步 血样表征过程，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对所有阳性培养物进行强制性革兰氏染色； 然后 3) 通过 MALDI-TOF 进行物种 ID（同样需要熟练的样品制备）、SpecID 与台式相比，该解决方案结合了更快的检测速度和更准确的革兰氏状态测定 染色和 ID 比 MALDI 更准确，只需一个完全自动化的步骤即可缩短染色时间 ID，简化实验室工作流程，并节省大量成本。结果是改善了患者的治疗效果 并提高了实验室的运营绩效。 该商业化准备试点 (CRP) 计划提案的目标反映了关键 II 期或 IIB 期计划不支持但实现商业化所需的目标 SpecID 血培养系统的市场进入包括： 血培养基的开发 制造工艺、质量控制和文件系统的开发、FDA 战略 SpecID血培养仪和血培养获得510(k)批准并开发 瓶子传感器附件。