A Nanotechnology Enabled Diagnostic Platform for Early Stage Cancer Detection

用于早期癌症检测的纳米技术诊断平台

• 批准号: 8338907
• 负责人: James C. Nelson
• 金额: $ 74.97万
• 依托单位: INANOVATE, INC.
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-08-14 至 2013-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8338907
• 关键词: Address; Antibodies; Autoantibodies; Benchmarking; Benign; Benign Prostatic Hypertrophy; Biological Assay; Biological Markers; Biopsy; Blood; Blood specimen; Cancer Detection; Cessation of life; Chairperson; Clinical Research; Clinical Trials; Colon Carcinoma; Computational Biology; Critiques; Data; Detection; Development; Diagnosis; Diagnostic; Diagnostic tests; Discrimination; Disease; Engineering; Evaluation; FDA approved; Feedback; Foundations; Goals; Health; Health system; Hospitals; Image; Industry; Knowledge; Laboratories; Lead; Legal patent; Life; Malignant Neoplasms; Malignant neoplasm of ovary; Malignant neoplasm of prostate; Marketing; Measurement; Measures; Methodology; Mission; Monitor; Multi-Institutional Clinical Trial; Nanotechnology; Optics; Patients; Performance; Phase; Play; Point-of-Care Systems; Preparation; Probability; Process; Prostate; Prostate-Specific Antigen; Proteins; Quality of life; Recording of previous events; Research Design; Research Personnel; Roswell Park Cancer Institute; Safety; Sampling; Screening for Prostate Cancer; Screening for cancer; Screening procedure; Series; Serum; Signal Transduction; Site; Specificity; Staging; Surface; System; Systems Analysis; Technology; Testing; Time; Urine; Urology; Validation; Woman; Work; assay development; base; biochip; cancer diagnosis; cost; cost effective; design; improved; innovation; lung cancer screening; male; malignant breast neoplasm; meetings; men; nanoparticle; next generation; novel; point of care; prototype; research study; technological innovation; true biomarker; tv watching

DESCRIPTION (provided by applicant): The objective of this proposal is the development, evaluation and validation of an accurate, low cost diagnostic test that can discriminate prostate cancer from benign prostatic hyperplasia to a Specificity of 85% at a Sensitivity of 85%. Prostate cancer is the most common cancer in men, with a probability of 1 in 6. Approximately 29% of all cancer cases in males are prostate cancer with 27,050 deaths estimated in 2009. As in most cancers, early and accurate detection can be life saving. However, a major deficiency of the current prostate cancer screening test, PSA, is that it does not discriminate between cancer and a common benign condition; benign prostatic hyperplasia (BPH). In fact, 88% of positive PSA tests are attributed to BPH. Although BPH is a non-threatening condition, only expensive biopsies can distinguish it from prostate cancer. Technological Innovation. Inanovate has partnered with investigators at Brigham and Women's Hospital (BWH) to identify a series of auto-antibody biomarkers capable of distinguishing prostate cancer from BPH to a Specificity of 85% at a Sensitivity of 85%. The proposed diagnostic test integrates this biomarker panel with a novel biochip platform capable of accurately screening multiple low concentration proteins from blood samples at the point of care. The platform includes a nano-particle surface technology that improves assay sensitivity by controlling the distribution and orientation of proteins across the biochip surface; and a real-time fluorescent biochip scanner and analysis methodology that enables the discrimination of 'specific' (true) biomarker signals from 'non-specific' (false) signals. Phase I Summary. The objective was to demonstrate the feasibility of using a nano-particle biochip surface technology in combination with real-time florescent imaging to measure the concentration of multiple autoantibody biomarkers for accurate detection of prostate cancer. In Phase I a prototype system was developed and tested. Following reviewer critiques from the original Phase II submission, the prototype platform has been substantially re-engineered, and the performance significantly improved. Through Phase II, this system will be advanced for point-of-care (PoC) use, in parallel with validation of the auto-antibody biomarker panel in preparation for multi-site clinical trials. Phase II Objectives. 1) Develop PoC version of the real-time flow-based screening platform, 2) Validate biomarkers using real-time measurement, 3) Prepare regulatory/commercial plans for clinical trials. Commercial Opportunity. The potential market for a point-of-care prostate cancer screening is estimated at over $2B p.a. Furthermore, by helping make accurate cancer screening available and affordable to everyone, we see the underlying diagnostic platform proposed herein playing a key role in moving the health industry's focus away from inefficient late stage treatments, towards early stage diagnosis and lower cost therapies.

描述（由申请人提供）：本提案的目的是开发、评估和验证一种准确、低成本的诊断测试，该测试可以区分前列腺癌和良性前列腺增生，特异性为 85%，灵敏度为 85%。 前列腺癌是男性中最常见的癌症，发病率为六分之一。大约 29% 的男性癌症病例是前列腺癌，2009 年估计有 27,050 人死亡。与大多数癌症一样，早期准确的检测可以挽救生命。然而，当前前列腺癌筛查测试 PSA 的一个主要缺陷是它不能区分癌症和常见的良性疾病。良性前列腺增生（BPH）。事实上，88% 的 PSA 检测阳性归因于 BPH。尽管良性前列腺增生是一种无威胁的疾病，但只有昂贵的活检才能将其与前列腺癌区分开来。 技术创新。 Inanovate 与布莱根妇女医院 (BWH) 的研究人员合作，确定了一系列能够区分前列腺癌和 BPH 的自身抗体生物标志物，特异性为 85%，灵敏度为 85%。所提出的诊断测试将该生物标记物组合与新型生物芯片平台相结合，能够在护理时从血液样本中准确筛选多种低浓度蛋白质。该平台包括纳米颗粒表面技术，通过控制蛋白质在生物芯片表面的分布和方向来提高测定灵敏度；实时荧光生物芯片扫描仪和分析方法，能够区分“特定”（真实）生物标志物信号与“非特定”（错误）信号。第一阶段总结。目的是证明使用纳米颗粒生物芯片表面技术与实时荧光成像相结合来测量多种自身抗体生物标志物的浓度以准确检测前列腺癌的可行性。在第一阶段，开发并测试了原型系统。根据最初的第二阶段提交的审稿人的批评，原型平台经过了大幅重新设计，性能显着提高。通过第二阶段，该系统将被推进用于护理点 (PoC) 使用，同时验证自身抗体生物标志物组，为多站点临床试验做准备。第二阶段目标。 1) 开发基于流程的实时筛选平台的 PoC 版本，2) 使用实时测量验证生物标志物，3) 为临床试验准备监管/商业计划。 商业机会。即时前列腺癌筛查的潜在市场估计每年超过 20 亿美元。此外，通过帮助每个人都能获得且负担得起准确的癌症筛查，我们看到本文提出的基础诊断平台在将健康行业的焦点从低效的后期治疗转向早期诊断和低成本治疗方面发挥着关键作用。