Near patient molecular diagnostics test for infections
患者附近感染分子诊断测试
基本信息
- 批准号:9202870
- 负责人:
- 金额:$ 98.96万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2010
- 资助国家:美国
- 起止时间:2010-03-15 至 2019-07-31
- 项目状态:已结题
- 来源:
- 关键词:AcuteAffectAgreementAntibiotic ResistanceAntibiotic TherapyAntibioticsAntimicrobial ResistanceAntimicrobial susceptibilityAreaAutomationBacteriaBacterial InfectionsBiological AssayBloodBlood specimenCenters for Disease Control and Prevention (U.S.)CertificationClassificationClinicalClinical ProtocolsClinical SensitivityCodeCulture MediaDataDetectionDevelopmentDevicesDiagnosisDiagnosticFeasibility StudiesGeneticGoalsGoldGrantGrowthGuidelinesHealth systemHealthcareHospitalsHourIncentivesInfectionInfection ControlInternationalInterventionMarketingMedical centerMethodsMichiganMolecularMolecular AnalysisMolecular Diagnostic TestingNational Institute of Allergy and Infectious DiseaseNosocomial InfectionsOutcomePatientsPatternPerformancePhasePowder dose formPredispositionPreparationProtocols documentationReadinessReagentRefrigerationRegulationReportingReproducibilityResearch Project GrantsResistanceResistance profileResistance to infectionRibosomal RNARiskSafetySamplingSensitivity and SpecificitySiteSmall Business Innovation Research GrantSpecimenStagingSwabSystemTechnologyTestingTimeUniversitiesUrinalysisUrinary tract infectionUrineWhole Bloodantimicrobialbaseclinical research sitecommercializationcostcost effectivedisorder preventionevidence baseimprovedmicroorganismmulti-drug resistant pathogenpathogenpoint of careprogramsresearch and developmentresearch clinical testing
项目摘要
ABSTRACT
Currently, there are no FDA cleared molecular-based tests for urinary tract infection (UTI) pathogen identification and
antimicrobial susceptibility testing to replace the 'gold standard' of dipstick urinalysis and urine culturing. All pathogen
identification tests still rely on clinical isolates from urine cultures, largely unchanged from Koch's postulates developed
in the 19th century as general guidelines to identify pathogens. What has changed over time, however, is the dramatic and
progressive emergence of antibiotic resistance among these pathogens. Data from the Centers for Disease Control and
Prevention (CDC) National Healthcare Safety Network (NHSN) indicate that 70% of the pathogens isolated from
hospital-acquired infections (HAIs) now are resistant to at least 2 major classes of antibiotics. Recent developments in
molecular diagnostic testing for multidrug resistant (MDR) pathogens can provide a sensitive, specific, and real-time
solution to support active surveillance-driven infection control interventions, but these PCR-based tests can only be
performed on simple specimen matrices such as swabs or positive blood culture media (1:10 blood-to-broth ratio). No
molecular-based method is cleared by the FDA to test directly on urine or whole blood samples.
The goal of this Commercialization Readiness Pilot (CRP) Grant is to accelerate the commercialization effort of the
program outcome from our NIAID SBIR R44AI088756 project titled “An Integrated Diagnostic System for Rapid
Antimicrobial Susceptibility Testing (AST)”. We propose technical assistance on regulatory strategy development and
cost-effective manufacturing, as well as later stage research and development activities on independent replication of key
studies in compliance with FDA requirements and ISO 13485 standards. The goal of our NIAID Advanced Technology
SBIR project is to develop and validate RAST (rapid antimicrobial susceptibility testing), an integrated and compact
diagnostic system that enables clinicians direct point-of-care (POC) with an evidence-based selection of antibiotics for
treatment of acute bacterial infections. Our first compact automated system is capable of rapid pathogen identification (ID)
and AST directly from patient's samples with evidenced-based information to start patient-specific antimicrobial treatment.
It is expected to obtain a CE Mark after the coming ISO 13485 surveillance certification audit in February 2016. However,
the FDA clearance is hindered by: (1) no molecular-based predicate test cleared by the FDA for urinary tract infections
(UTI), (2) the low cost of conventional dipstick urinalysis tests, and (3) the lack of fresh urine specimens through a multi-
site clinical feasibility study.
We will overcome these hurdles through the following aims:
TECHNICAL ASSISTANCE
Aim 1: Obtain a risk-based classification of the Class II device through a de novo request with external
regulatory assistance from NSF International (an international certification organization) in 18 months
Aim 2: Reduce the cost of goods sold of <$3 for cartridge and <$5k for system with external manufacturing
development assistance
LATE STAGE RESEARCH AND DEVELOPMENT ACTIVITIES
Aim 3: Conduct a multi-center clinical performance study and demonstrate >95% clinical
sensitivity/specificity and >95% susceptibility categorical agreement
In this study, we focus on validating the rapid UTI diagnostic device according to federal regulations 21 CFR 866.2660
(microorganism differentiation and identification device), 21 CFR 866.1640 (antimicrobial susceptibility test powder),
and 21 CFR 866.1645 (fully automated, short-term incubation cycle antimicrobial susceptibility testing system). The FDA
product codes for such systems are “JSS” and “LON.” The regulatory strategy will be finalized in Aim 1 (Regulatory) for
preparation of the clinical protocol and multicenter clinical performance study in Aim 3 (Clinical study) that will utilize
the cost-effective system and consumables optimized in Aim 2 (Manufacturing).
抽象的
目前,没有FDA清除基于分子的测试,用于尿路感染(UTI)病原体鉴定和
抗菌敏感性测试,以取代二金尿液分析和尿液培养的“黄金标准”。所有病原体
识别测试仍然依赖于尿培养物中的临床分离株,这在很大程度上没有从科赫的假设中不变
在19世纪,作为识别病原体的一般指南。然而,随着时间的流逝发生了变化,是戏剧性的
这些病原体中抗生素抗性的逐步出现。来自疾病控制中心的数据
预防(CDC)国家医疗保健安全网络(NHSN)表明,从与之隔离的病原体中有70%
现在,医院可获得的感染(HAIS)对至少2种主要类别的抗生素具有抵抗力。最近的发展
对多药耐药(MDR)病原体的分子诊断测试可以提供敏感,特定和实时的
支持主动监视驱动的感染控制干预措施的解决方案,但是这些基于PCR的测试只能是
在简单的标本基质(例如拭子或阳性血液培养基)上进行(1:10血液与肉汤比)。不
FDA清除了基于分子的方法,以直接在尿液或全血样品上进行测试。
这种商业化准备飞行员(CRP)赠款的目的是加快商业化工作
我们的NIAID SBIR R44AI088756项目的计划结果名为“快速的集成诊断系统
抗菌敏感性测试(AST)”。我们就监管策略制定和
具有成本效益的制造业以及后来的阶段研究和开发活动,有关关键的独立复制
符合FDA要求和ISO 13485标准的研究。我们的NIAID先进技术的目标
SBIR项目将开发和验证Rast(快速抗菌敏感性测试),一种综合而紧凑的
诊断系统,使临床医生可以直接护理点(POC),以循证的抗生素选择用于
治疗急性细菌感染。我们的第一个紧凑自动化系统能够快速病原体鉴定(ID)
并直接从患者的样本中获得基于证据的信息,以开始患者特异性抗菌治疗。
预计将在2016年2月的ISO 13485监视认证审核之后获得CE标记。但是,
FDA的清除受到以下方式阻碍:(1)没有FDA清除尿路感染的基于分子的谓词测试
(UTI),(2)常规分离的尿液分析测试的低成本,以及(3)缺乏通过多种新鲜尿液标本
现场临床可行性研究。
我们将通过以下目标克服这些障碍:
技术援助
目标1:通过外部的从头请求获得基于风险的II类设备的分类
18个月内NSF International(国际认证组织)的监管援助
AIM 2:降低墨盒售价<3美元的商品成本,用于外部制造的系统<$ 5K
发展援助
后期的研发活动
AIM 3:进行多中心临床性能研究,证明> 95%的临床
灵敏度/特异性和> 95%的易感性分类协议
在这项研究中,我们专注于根据联邦法规21 CFR 866.2660验证快速UTI诊断设备
(微生物分化和识别装置),21 CFR 866.1640(抗菌易感性测试粉),
和21 CFR 866.1645(完全自动化的短期孵育周期抗菌易感性测试系统)。 FDA
此类系统的产品代码为“ JSS”和“ LON”。监管策略将在AIM 1(法规)中最终确定
在AIM 3(临床研究)中的临床方案和多中心临床性能研究的准备
在AIM 2(制造)中优化了具有成本效益的系统和消耗品。
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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Vincent Jen-Jr Gau其他文献
Vincent Jen-Jr Gau的其他文献
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