Point of care detection of HPV in saliva
唾液中 HPV 的护理点检测
基本信息
- 批准号:10761543
- 负责人:
- 金额:$ 32.97万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2023
- 资助国家:美国
- 起止时间:2023-09-12 至 2024-09-11
- 项目状态:已结题
- 来源:
- 关键词:Base SequenceBiochemicalBiological AssayBiological MarkersBiosensorCancerousCaringChemical EngineeringClinicalClustered Regularly Interspaced Short Palindromic RepeatsDNADNA amplificationDataDentistsDetectionDevelopmentDevicesDiagnosisDiagnosticDiseaseEarly DiagnosisElectrodesEngineeringEnsureEnzymesFutureGenesGenetic MaterialsGoalsGoldGuide RNAHPV-High RiskHousekeepingHousekeeping GeneHuman PapillomavirusHuman papilloma virus infectionHuman papillomavirus 16Human papillomavirus 18IncidenceLaboratoriesMalignant NeoplasmsMassachusettsMedicalMethodsMicrofluidic MicrochipsMicrofluidicsMonitorMonitoring for RecurrenceMorbidity - disease rateMultiple PartnersNucleic AcidsOropharyngeal Squamous Cell CarcinomaPathologistPatientsPerformancePersonal SatisfactionPhasePlant LeavesPoint of Care TechnologyPredictive ValuePreparationProgram DevelopmentROC CurveReagentRecurrenceResourcesReverse Transcriptase Polymerase Chain ReactionSalivaSamplingSensitivity and SpecificitySerumSextingSignal TransductionSmall Business Innovation Research GrantSore ThroatSpecimenSymptomsSystemTechnologyTest ResultTestingTimeUnited StatesUnited States National Institutes of HealthValidationViralVirus DiseasesWorkamplification detectionassay developmentcommercializationcostdesigndetection assaydetection sensitivitydetection testdiagnostic assaydiagnostic platformeffective therapyendonucleasehigh riskhigh risk populationimprovedinnovationinventionmalignant oropharynx neoplasmmanufacturemanufacturing process developmentmortalitymultiplex detectionnon-invasive monitornovelnucleic acid deliverynucleic acid detectionparticleplasmid DNApoint of carepoint of care testingpoint-of-care detectionprecision medicineprocess repeatabilityproduct developmentprogramspromote resilienceprototyperelapse patientsscreeningsuccesstechnology platformtranslational medicinetreatment responseviral detectionvirus genetics
项目摘要
Expanded point-of-care (POC) screening and monitoring options for detection of disease biomarkers from easily
collectable specimens such as saliva are needed to reduce the incidence and mortality rates of debilitating
diseases and enhance the resilience of the medical system, and improve care. InnoTech Precision Medicine
with Massachusetts Institute of Technology is working to develop an innovative diagnostic platform that can be
used for POC screening and monitoring of disease biomarkers. In our initial proof-of-concept, we are developing
a POC test for detection of high-risk HPV in saliva. HPV is a viral infection that causes most Oropharyngeal
squamous cell carcinoma (OPSCC) cases. Recent studies have demonstrated that HPV can be detected in
saliva from patients with OPSCC. Currently, the initial screening and diagnosis of OPSCC is done at the late
symptomatic stage based on symptoms that are often mild and can mimic less serious conditions such as cold
or sore throat, delaying diagnosis and treatment. DNA tests for HPV are most often based on RT-PCR detection
of the viral genetic material from serum or saliva that is collected and sent to central laboratories. RT-PCR-based
tests rely on the amplification and detection of viral genetic material. These tests have long actionable turn-
around-time, and high cost. Thus, there are no rapid, accurate and low-cost tests for routine monitoring of high-
risk groups (i.e., young, sextually active, multiple partner) and monitoring of response to therapy and recurrence.
Thus, a POC test for non-invasive monitoring of HPV in saliva during well-being exams can have a significant
impact and save lives. Our objective is to develop a rapid, easy-to-use prototype for the detection of HPV in
saliva based on the combination of biochemical signal amplification with CRISPR-Cas 12 electrochemical
readout and our proprietary robust, accurate and low-cost gold-leaf electrodes. Utilizing our proprietary gold-leaf
electrode along with a CRISPR-Cas12 assay for sensitive and specific electrochemical detection of target nucleic
acid (NA) biomarkers, we have already demonstrated the detection of HPV 18 with plasmid DNA as well as in
patient specimen. Our overall objective for this proposal is to develop a reproducible process for processing of
saliva and develop a prototype electrochemical biosensor for the multiplex detection of HPV 16 and HPV 18
along with a reference gene to ensure accurate test results. To accomplish this goal, we will first develop a
workflow for spatial multiplexing of our gold leaf electrodes for detection of HPV16, HPV 18 and an optimal
reference gene. We will then verify this multiplexed test initially with plasmid DNA, and then with saliva
specimens. We anticipate that combining easy-to-fabricate spatially multiplexed electrodes with CRISPR-
Cas12a for the detection of a specific nucleic acid sequence will enable our Phase II development, regulatory
approval and commercialization of a point-of-need technology that can be scaled and manufactured for accurate,
easy-to-use and low-cost point-of-need testing and to reduce the burden of HPV infection and OPSCC.
扩大床旁(POC)筛查和监测选项,用于检测疾病生物标志物,
需要可收集的样本,如唾液,以减少衰弱性疾病的发病率和死亡率。
加强医疗系统的复原力,并改善护理。InnoTech精准医疗
与马萨诸塞州理工学院正在努力开发一个创新的诊断平台,可以
用于POC筛查和疾病生物标志物监测。在我们最初的概念验证中,我们正在开发
POC测试用于检测唾液中的高危HPV。HPV是一种病毒感染,
鳞状细胞癌(OPSCC)病例。最近的研究表明,HPV可以在
口腔鳞状细胞癌患者的唾液目前,OPSCC的初步筛查和诊断是在晚期进行的。
症状阶段,症状通常很轻微,可以模仿不太严重的情况,如感冒
或咽喉痛,延误诊断和治疗。HPV的DNA检测通常基于RT-PCR检测
收集并送往中心实验室的血清或唾液中的病毒遗传物质。基于RT-PCR
测试依赖于病毒遗传物质的扩增和检测。这些测试有很长的可操作性-
时间长,成本高。因此,没有快速、准确和低成本的检测方法用于常规监测高血压。
风险组(即,年轻、性活跃、多性伴)和监测对治疗的反应和复发。
因此,在健康检查期间用于唾液中HPV的非侵入性监测的POC测试可以具有显著的
影响和拯救生命。我们的目标是开发一种快速,易于使用的原型,用于检测HPV,
基于生物化学信号放大与CRISPR-Cas 12电化学的组合的唾液
读数和我们专有的坚固、准确和低成本的金叶电极。利用我们专有的金叶
电极沿着CRISPR-Cas 12测定用于靶核酸的灵敏和特异性电化学检测
酸性(NA)生物标志物,我们已经证明了用质粒DNA检测HPV 18以及在
病人标本我们提出这项建议的总体目标是开发一种可重复的工艺,
唾液,并开发用于HPV 16和HPV 18多重检测的原型电化学生物传感器
沿着参考基因以确保准确的测试结果。为了实现这一目标,我们将首先开发一个
我们的金箔电极用于检测HPV 16、HPV 18的空间多路复用的工作流程,
参考基因然后,我们将首先用质粒DNA,然后用唾液来验证这种多重测试
标本我们预计,将易于制造的空间多路复用电极与CRISPR-
Cas 12 a用于检测特定的核酸序列将使我们的II期开发、调控
批准和商业化的一个点的需要的技术,可以规模和制造的准确,
易于使用和低成本的需求点检测,并减少HPV感染和OPSCC的负担。
项目成果
期刊论文数量(0)
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{{ truncateString('ROYA KHOSRAVI-FAR', 18)}}的其他基金
A multimodal platform for Oral screening of COVID-19
用于 COVID-19 口腔筛查的多模式平台
- 批准号:
10665346 - 财政年份:2022
- 资助金额:
$ 32.97万 - 项目类别:
A multimodal platform for Oral screening of COVID-19
用于 COVID-19 口腔筛查的多模式平台
- 批准号:
10266378 - 财政年份:2020
- 资助金额:
$ 32.97万 - 项目类别:
Novel Strategies for Treatment of Myeloproliferative Disorders
治疗骨髓增殖性疾病的新策略
- 批准号:
7670523 - 财政年份:2008
- 资助金额:
$ 32.97万 - 项目类别:
Novel Strategies for Treatment of Myeloproliferative Disorders
治疗骨髓增生性疾病的新策略
- 批准号:
8271290 - 财政年份:2008
- 资助金额:
$ 32.97万 - 项目类别:
Novel Strategies for Treatment of Myeloproliferative Disorders
治疗骨髓增生性疾病的新策略
- 批准号:
8092728 - 财政年份:2008
- 资助金额:
$ 32.97万 - 项目类别:
Novel Strategies for Treatment of Myeloproliferative Disorders
治疗骨髓增生性疾病的新策略
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7523599 - 财政年份:2008
- 资助金额:
$ 32.97万 - 项目类别:
Novel Strategies for Treatment of Myeloproliferative Disorders
治疗骨髓增生性疾病的新策略
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7846141 - 财政年份:2008
- 资助金额:
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