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
基本信息
- 批准号:9335244
- 负责人:
- 金额:$ 99.67万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 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:
- 关键词:BloodBlood specimenCause of DeathCessation of lifeClinical TrialsComputer softwareCulture MediaDetectionDevelopmentDevicesDiagnosisDocumentationEnsureFundingGoalsGrantHealthcare SystemsHospital CostsHospitalsInfectionMolecular ProbesPatient-Focused OutcomesPerformancePhasePreparationProcessQuality ControlReadinessSamplingSensorySepsisSpectrometry, Mass, Matrix-Assisted Laser Desorption-IonizationStaining methodStainsStreamSystemTimeTrainingWorkbasecommercializationcostdesigneffective therapyimprovedinstrumentmanufacturing process developmentnew technologyoperationpathogenic bacteriaprogramsroutine Bacterial stainsensorverification and validation
项目摘要
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,占美国所有死亡人数的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
每年十亿。每年生产3亿多个血培养瓶,市场
仅在美国和欧盟就超过12亿美元。
第二阶段为期两年,从2013年2月至2015年2月(5 R44 AI 094781 -03)。的
部分由这笔赠款资助的发展创造了一种新的诊断血流的模式,
感染导致败血症。这项赠款的工作有助于建立SpecID血液培养
该公司目前正在商业化。SpecID解决方案取代了现有的3步
血液样本的表征过程,目前分为1)感染检测; 2)
由经过培训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的物种ID(同样需要熟练的样品制备),
该解决方案结合了比台式机更快的检测、更准确的革兰氏状态确定
染色和ID比MALDI更准确,在一个完全自动化的步骤中,
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预后
提高了实验室的操作性能。
本商业化准备试点(CRP)计划提案的目标反映了
II期或IIB期计划不支持的目标,但需要实现商业目标
SpecID血培养系统的市场准入,包括:血培养基的开发
生产工艺,质量控制和文件系统的开发,FDA的战略,
获得510(k)批准,开发SpecID血培养仪和血培养
瓶传感器附件。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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Ray Anthony Martino其他文献
Ray Anthony Martino的其他文献
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{{ truncateString('Ray Anthony Martino', 18)}}的其他基金
Oxidative Stress Biosensor for Breath-Based Environmental Monitoring
用于基于呼吸的环境监测的氧化应激生物传感器
- 批准号:
9408215 - 财政年份:2017
- 资助金额:
$ 99.67万 - 项目类别:
Rapid Identification of Pathogenic Bacteria and Sepsis Diagnosis
病原菌快速鉴定及脓毒症诊断
- 批准号:
8522889 - 财政年份:2012
- 资助金额:
$ 99.67万 - 项目类别:
Rapid Identification of Pathogenic Bacteria and Sepsis Diagnosis
病原菌快速鉴定及脓毒症诊断
- 批准号:
8252659 - 财政年份:2012
- 资助金额:
$ 99.67万 - 项目类别:
Rapid breath detection of colorectal cancer with a colorimetric sensor array
使用比色传感器阵列快速呼吸检测结直肠癌
- 批准号:
8383030 - 财政年份:2012
- 资助金额:
$ 99.67万 - 项目类别:
Rapid Identification of Pathogenic Bacteria and Sepsis Diagnosis
病原菌快速鉴定及脓毒症诊断
- 批准号:
8619581 - 财政年份:2012
- 资助金额:
$ 99.67万 - 项目类别:
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:
9141453 - 财政年份:2012
- 资助金额:
$ 99.67万 - 项目类别:
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2286334 - 财政年份:1996
- 资助金额:
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CLINICAL LABORATORY BLOOD SPECIMEN INSPECTION SYSTEM
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- 批准号:
2030324 - 财政年份:1996
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