SBIR Phase I:Advanced microfluidic systems enabling development of novel circulating tumor cell diagnostics

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is to improve the diagnosis, risk assessment, and monitoring of cancer. Nearly 40% of Americans will be diagnosed with cancer in their lifetime. Diagnosis of cancer in later stages dramatically reduces treatment options, leading to poor prognosis and low survival rates. In addition, the average cost of treatment for late-stage patients can be 3–5 times higher than that for early-stage patients due to the potential need for multiple rounds of expensive therapies. These multiple rounds of treatment contribute to the high economic burden of cancer. Thus, detecting cancer earlier will not only lead to improved patient outcomes but will likely reduce the overall costs of cancer treatment. Moreover, a minimally invasive and highly accurate diagnostic could be broadly administered to effectively identify those with various cancers, enhancing the commercial potential further. _x000D_ _x000D_ This Small Business Innovation Research (SBIR) Phase I project seeks to develop an advanced microfluidic system for the isolation and assessment of circulating tumor cells (CTCs) and CTC clusters (CTCCs) for cancer diagnosis and monitoring. Microfluidic devices in various forms have been developed to isolate the extremely rare CTC population from billions of blood cells, but these technologies suffer from three major problems: 1) low sample purity, 2) low numbers of isolated CTCs/CTCCs, and 3) CTC/CTCC heterogeneity. To overcome these limitations, this project will develop an innovative device for the simultaneous isolation and assessment of single and clustered CTCs and their molecular signatures, enabling the implementation of new, highly sensitive and accurate liquid biopsies for cancer. The key objectives for this project are: 1) Design and develop a hybrid microfluidic system for simultaneous isolation and concentration of CTCs and CTCCs with high purity, 2) Develop and optimize two devices for single CTC and CTCC analysis, and 3) Testing and validation using prostate cancer patient specimens. This research will lead to the development of a new cancer diagnostics platform that is minimally invasive and more sensitive and accurate than current methods, expanding treatment options and improving patient outcomes._x000D_ _x000D_ This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.