SBIR Phase I: Development of a Device for Early Detection of Uterine Cancer Cells at the Point-of-Care

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project, if successful, will be the implementation of an effective point-of-care (POC) test that will not only impact the lives of patients, but can reduce the costs to hospitals, health insurances companies, and government agencies. According to the National Institutes of Health, cancer cost the U.S. an estimated $219 billion in 2007, including $130 billion for lost productivity and $89 billion in direct medical costs. The proposed screening technology is expected to help gynecologists in hospitals or in private practice to provide a complete diagnosis in less time, reducing the number of visits and the endometrial cancer incidence through an early detection, especially in women over 50 years old. This would benefit the medical insurance by lowering the cost per patient with this type of cancer. If successful, the proposed non-label/real-time cancer diagnostic device will contribute to new scientific findings and engineering aspects in bio-sensing technology. The resulting device will also provide a non-invasive, fast, and accurate method to detect cancer for preclinical diagnosis. In addition, the research based on this technology will improve a range of equivalent studies that use similar systems and biological indicators. The proposed project is aimed to develop a POC technology for the sensitive detection of telomerase as a cancer measurable indicator in real-time. Telomerase is a distinctive enzyme whose presence in cells or tissues is used for screening, early cancer detection, prognosis and/or monitoring a residual cancer disease. The proposed technology is based on the detection of telomerase in cancer cells through the measuring of an in-situ elongation process of an immobilized label-free single strand DNA probe by means of sensitive electrochemical events occurring at the conductive gold microchip surface. For the development of this new sensing microchip device the team will use commercially available products. Silicon wafers have been used as substrate with gold as electrodes due to their reliability but these materials are expensive and the fabrication is labor intensive. Therefore, important diagnostic device parameters will be studied after incorporation of bare bio-sensing strips. Phase I of this project, is aimed at demonstrating the feasibility of the proposed technology as well as testing the reliability and robustness of the microchip biosensor using uterine cancer samples.