Bladder cancer (BC) represents a major health problem throughout the world. It is estimated that in the United States, 73,510 men and women were diagnosed with BC and 14,880 died of the disease in 2012. Often, early diagnosis of cancer enhances survival rates and enables optimal risk assessment. One major problem for the diagnosis of BC is the lack of distinct symptoms associated with the disease, so it is necessary to rely on medical testing. To address this problem, Physical Optics Corporation (POC) proposes to develop a Waveguide Array Biosensor (WABS) for early diagnosis of bladder cancer. The WABS system is based on a long period grating (LPG) array built on an integrated optical chip (IOC), which is coated with capture antibodies corresponding to a panel of urinary biomarkers of bladder cancer. WABS is a hybrid construction with an optical chip mounted onto a silicon substrate. The biosensor is fabricated using microelectromechanical system (MEMS) technology. The sensor will provide a rapid and accurate assessment of the presence of multiple urinary protein biomarkers of bladder cancer in urine samples. WABS consists of optical waveguides, edge-mounted laser diodes (LDs), and photodetectors (PDs). The optical waveguides, fabricated on a LiNbO3 chip, will be bonded to the silicon on top of strain-relieved posts micromachined onto silicon. We will embed an artificial neural network (ANN) algorithm in the electronics, which will significantly increase the accuracy of biomarker detection. The WABS system will be a label-free, one-step, point-of-care screening tool for the early detection of bladder cancer and will provide an attractive alternative to invasive diagnostic methods such as cystoscopy. In Phase I, the WABS system will be designed for optimal sensitivity and limit of detection. The system will be assembled with a microfluidic module for handling very low sample volumes (<10 mL). POC will demonstrate the feasibility of the WABS system by fabricating components, assembling a prototype, and demonstrating its capability for label-free identification and quantitation of multiple BC biomarkers such as NMP22, Lewis X, BTA, UPK3A, and BLCA-4 spiked in artificial urine samples. In Phase II, the WABS system will be expanded to achieve multiplex detection of several cancer biomarkers and tested using clinical samples. The system will also be optimized to offer rapid detection, automatic data analysis, and low manufacturing cost aimed at the potential for mass production. This Phase I study will lead to the development of an instrument that can be used for cancer staging, assessing a patient's response to anticancer therapy, and subsequent monitoring.
The proposed WABS system will offer a very sensitive, inexpensive, one-step, point-of-care screening tool for the early diagnosis of bladder cancer. This system can be used for cancer screening tests, cancer staging, monitoring of disease recurrence, and assessment of a patient's response to anticancer therapy. WABS can be used in hospitals, physicians'offices, clinical settings, laboratories, and households.