A Nanotechnology Enabled Point of Care Diagnostic Platform for Early Stage Cancer

DESCRIPTION (provided by applicant): The objective of this proposal is the development, evaluation and validation of a reliable, highly sensitive, point-of-care (P.O.C) diagnostic system, for the early detection and subsequent monitoring of prostate cancer. Of cancers in males, the most common is prostate, with a probability of 1 in 6. Approximately 29% (218,890) of all cancer cases in males are prostate cancer with 27,050 deaths expected. Taking prostate cancer diagnosis to the point-of-care, and incorporating a test for a larger, more specific set of biomarkers, onto a low cost disposable platform would significantly increase survival rates and reduce treatment costs. Technological Innovation. This project is innovative in the use of a nano-particle biochip surface in the context of a protein microarray assay. We aim to exploit the nano-particle attachment approach developed by Inanovate, with the native antigen reverse-capture method developed at Brigham and Women's Hospital (BWH) to obtain very high correlation rates to prostate cancer. Finally the combination of these two innovations with a real-time read-out enables the test to be performed at point-of-care. Long-Term Goal. The long term goal is to provide a premier platform from which cancer can be detected at an early stage and monitored after and during treatment. The first example of this goal will be the launch of a screening test for prostate cancer that will be both sensitive, accurate, and widely available at the point-of-care. Phase I Summary. The objective is to demonstrate the feasibility of using a nano-particle based biochip substrate in combination with real-time florescent imaging to measure the concentration of multiple autoantibody biomarkers for early stage detection of prostate cancer. Specific Aims for Phase I. Aim 1 is to optimize end-point assay performance within the context of the nano- particle biochip substrate. Assay development experiments will be performed with the 28 biomarkers identified at BWH. Aim 2 is to develop a real-time fluorescent detection systems specifically suited for the BWH approach. Aim 3 is to show direct comparisons to the end-point data collected in Aim 1 and the ability to detect previously identified prostate cancer correlation signatures in the real-time mode. Phase II Objectives. 1) Integrate automated sample preparation and labeling into platform module, and prepare for Device Master Filing (DMF). 2) Streamline supply and incorporation of bait proteins into disposable chip. 3) Finalize biomarker panel validation in collaboration with BWH, and design multi-site clinical trial for Pre-Market Approval (PMA). 4) Initiate DMF and PMA with support from partners. Commercial Opportunity. The potential market for P.O.C 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. PUBLIC HEALTH RELEVANCE: Treatments are available for most cancers; however, survival rates depend largely on the stage at which the cancer is diagnosed. The problem is related to having an accurate test, but also related to the cost and widespread availability of such a test. We propose to develop a nanotechnology enabled protein signature based diagnostic test for prostate cancer available at the point of primary care.