Point-of-care HPV mRNA test for cervical cancer screening in low-resource settings

在资源匮乏地区进行宫颈癌筛查的护理点 HPV mRNA 检测

基本信息

  • 批准号:
    10331882
  • 负责人:
  • 金额:
    $ 18.19万
  • 依托单位:
  • 依托单位国家:
    美国
  • 项目类别:
  • 财政年份:
    2021
  • 资助国家:
    美国
  • 起止时间:
    2021-02-01 至 2023-01-31
  • 项目状态:
    已结题

项目摘要

Abstract: There is a significant need to improve global access to cervical cancer screening. Globally, approximately 570,000 women are diagnosed with and 311,000 women die from cervical cancer each year. Nearly 90 percent of cervical cancer deaths occur in low- and middle-income countries (LMICs), due mainly to challenges in implementing effective screening programs. Likewise, cervical cancer rates in medically underserved areas in the US remain high. For example, in the Rio Grande Valley of Texas, cervical cancer incidence rates are 55% higher than the US average, and approximately 10% of eligible women are screened. There is broad consensus that high-risk human papillomavirus (hrHPV) testing is the best approach to improve global screening efforts. An HPV biomarker that provides excellent sensitivity and better specificity than DNA is hrHPV mRNA. However, currently available hrHPV mRNA testing remains too complex and costly (e.g. >$45,000 for equipment and roughly $74 per test) for effective implementation into low-resource and medically underserved settings. Advances in isothermal amplification and lateral flow detection offer an opportunity to develop a point-of-care (POC) hrHPV mRNA test that is accurate, affordable, and can be performed in low-resource settings. The goal of this proposal is to combine isothermal amplification and lateral flow detection within an integrated point-of- care device to dramatically lower the cost of hrHPV mRNA testing. We will develop a low-cost, POC hrHPV E7 mRNA test that requires minimal laboratory equipment and performs as well as commercial RNA tests. Isothermal amplification reduces the instrumentation cost and complexity typically associated with nucleic acid amplification requiring only a single-temperature heater. Lateral flow detection integrates sample manipulation processes and wicks all detection reagents past pre-defined test zones, producing a simple, colorimetric readout. Our proposed proof-of-concept test will detect HPV types 16 and 18, the two types responsible for 70% of cervical cancer, and we estimate will cost <$3 per test in low-volume production. Consistent with the exploratory/developmental goals of an R21 proposal, we aim to (1) design and optimize HPV 16 and 18 E7 mRNA amplification assays and lateral flow detection; (2) combine mRNA amplification and detection into a single POC device; (3) evaluate performance of the developed mRNA test using synthetic and clinical samples. We will leverage the expertise of our interdisciplinary team, which includes designing technologies for LMICs, cervical cancer care, HPV diagnostics, and epidemiology, to develop, validate, and translate this novel screening test. We intend to build from this proof-of-concept test to incorporate HPV mRNA detection for types 31,33, 35, 45, 52, and 58 in the future to achieve detection of the HPV types that cause >90% of cervical cancer. Collectively, this research will lead to the development and implementation of a scalable, cost- effective screening test, a critical and necessary step toward the global elimination of cervical cancer.
文摘:

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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Rebecca R. Richards-Kortum其他文献

A novel method for semi-quantitative detection of HPV16 and HPV18 mRNA with a low-cost, open-source fluorimeter
  • DOI:
    10.1007/s00216-025-05765-8
  • 发表时间:
    2025-02-07
  • 期刊:
  • 影响因子:
    3.800
  • 作者:
    Kathryn A. Kundrod;Mary E. Natoli;Chelsey A. Smith;Jackson B. Coole;Megan M. Chang;Emilie Newsham Novak;Elizabeth Chiao;Elizabeth A. Stier;Jane R. Montealegre;Michael E. Scheurer;Philip E. Castle;Kathleen M. Schmeler;Rebecca R. Richards-Kortum
  • 通讯作者:
    Rebecca R. Richards-Kortum
A paper-based HPV E7 oncoprotein assay for cervical precancer detection at the point of care
  • DOI:
    10.1038/s41598-024-79472-2
  • 发表时间:
    2025-01-24
  • 期刊:
  • 影响因子:
    3.900
  • 作者:
    Chelsey A. Smith;Sai Paul;Karen E. Haney;Sonia G. Parra;Meaghan Bond;Leticia López;Mauricio Maza;Juan Felix;Preetha Ramalingam;Pablo Escobar;Philip E. Castle;Kathleen M. Schmeler;Rebecca R. Richards-Kortum
  • 通讯作者:
    Rebecca R. Richards-Kortum
A High-Resolution Microendoscope Improves Esophageal Cancer Screening and Surveillance: Implications for Underserved Global Settings Based on an International Randomized Controlled Trial
基于一项国际随机对照试验,高分辨率微型内窥镜改善了食管癌筛查和监测:对服务不足的全球环境的影响
  • DOI:
    10.1053/j.gastro.2024.10.025
  • 发表时间:
    2025-03-01
  • 期刊:
  • 影响因子:
    25.100
  • 作者:
    Mimi C. Tan;Zhengqi Li;Kalpesh K. Patel;Fan Zhang;Xinying Yu;Xueshan Wang;Daniel G. Rosen;Sanford M. Dawsey;Liyan Xue;Chin Hur;Richard A. Schwarz;Imran Vohra;Yubo Tang;Mengfen Wu;Tao Wang;Jennifer Carns;Hong Xu;Rebecca R. Richards-Kortum;Guiqi Wang;Sharmila Anandasabapathy
  • 通讯作者:
    Sharmila Anandasabapathy

Rebecca R. Richards-Kortum的其他文献

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{{ truncateString('Rebecca R. Richards-Kortum', 18)}}的其他基金

Technology Core
技术核心
  • 批准号:
    10715742
  • 财政年份:
    2023
  • 资助金额:
    $ 18.19万
  • 项目类别:
A Sample-to-Answer Point-of-Care Diagnostic for Recently Transfused Sickle Cell Anemia Patients in Low Resource Settings
针对资源匮乏地区最近输血的镰状细胞性贫血患者的从样本到答案的护理点诊断
  • 批准号:
    10564553
  • 财政年份:
    2023
  • 资助金额:
    $ 18.19万
  • 项目类别:
The Center for Innovation and Translation of Point of Care Technologies for Equitable Cancer Care (CITEC) - Administrative Core
公平癌症护理护理点技术创新与转化中心 (CITEC) - 行政核心
  • 批准号:
    10715741
  • 财政年份:
    2023
  • 资助金额:
    $ 18.19万
  • 项目类别:
Dissemination Core
传播核心
  • 批准号:
    10715744
  • 财政年份:
    2023
  • 资助金额:
    $ 18.19万
  • 项目类别:
Clinical Core
临床核心
  • 批准号:
    10715743
  • 财政年份:
    2023
  • 资助金额:
    $ 18.19万
  • 项目类别:
Low-cost mobile colposcopy and confocal imaging for global prevention of cervical cancer
低成本移动阴道镜和共聚焦成像用于全球宫颈癌预防
  • 批准号:
    10672941
  • 财政年份:
    2020
  • 资助金额:
    $ 18.19万
  • 项目类别:
Low-cost mobile colposcopy and confocal imaging for global prevention of cervical cancer
低成本移动阴道镜和共焦成像在全球宫颈癌预防中的应用
  • 批准号:
    10219206
  • 财政年份:
    2020
  • 资助金额:
    $ 18.19万
  • 项目类别:
Low-cost mobile colposcopy and confocal imaging for global prevention of cervical cancer
低成本移动阴道镜和共聚焦成像用于全球宫颈癌预防
  • 批准号:
    10406973
  • 财政年份:
    2020
  • 资助金额:
    $ 18.19万
  • 项目类别:
Low-cost mobile colposcopy and confocal imaging for global prevention of cervical cancer
低成本移动阴道镜和共焦成像在全球宫颈癌预防中的应用
  • 批准号:
    10031954
  • 财政年份:
    2020
  • 资助金额:
    $ 18.19万
  • 项目类别:
High resolution imaging & HPV oncoprotein detection for global prevention of cerv
高分辨率成像
  • 批准号:
    8912437
  • 财政年份:
    2014
  • 资助金额:
    $ 18.19万
  • 项目类别:

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