A Nanotechnology Enabled Diagnostic Platform for Early Stage Cancer Detection

点击翻译按钮获取中文摘要

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.