A Nanotechnology Enabled Diagnostic Platform for Early Stage Cancer Detection

描述（由申请人提供）：本申请的目的是开发、评估和验证一种准确、低成本的诊断测试，该测试可以将前列腺癌与良性前列腺增生区分开来，特异性为85%，敏感性为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，早期和准确的检测可以挽救生命。然而，目前前列腺癌筛查试验PSA的一个主要缺陷是它不能区分癌症和常见的良性疾病；前列腺增生（BPH）。事实上，88%的PSA检测阳性归因于前列腺增生。虽然前列腺增生是一种无害的疾病，但只有昂贵的活组织检查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，鉴定了一系列能够区分前列腺癌和前列腺增生的自身抗体生物标志物，特异性为85%，灵敏度为85%。拟议的诊断测试将这种生物标志物面板与一种新型生物芯片平台集成在一起，能够在护理点准确筛选血液样本中的多种低浓度蛋白质。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检测灵敏度；实时荧光生物芯片扫描仪和分析方法，能够区分“特异性”（真）生物标志物信号和“非特异性”（假）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，一个原型系统被开发和测试。根据最初的第二阶段提交的评审意见，原型平台已经进行了实质性的重新设计，并且性能得到了显著改善。通过二期试验，该系统将被推进到医疗点（PoC）使用，同时验证自身抗体生物标志物面板，为多地点临床试验做准备。II期目标：1)开发PoC版本的实时流量筛选平台，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，通过帮助每个人获得准确的癌症筛查并负担得起，我们看到本文提出的潜在诊断平台在将健康行业的重点从低效的晚期治疗转向早期诊断和低成本治疗方面发挥了关键作用。

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.