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272 Point of Care Analysis of Circulating Tumor Cells for Cancer Diagnostics, Prognosis, and Treatment

Number of anticipated awards: 4

(Fast-Track proposals will be accepted.)

Budget (total costs): Phase I: $200,000;
Phase II: $1,000,000

(Note: Proposals with budgets exceeding the above amounts will be returned without review. Phase I project periods may last a maximum of 9 months. Proposals with durations exceeding 9 months will be returned without review.)

The deadline for receipt of all contract proposals submitted in response to this solicitation is: November 9, 2009.

Summary:
Circulating tumor cells (CTCs) are cancer cells that shed from either the primary tumor or its metastases and are circulating in the peripheral blood. While metastases are directly responsible for the majority of cancer deaths, CTCs may constitute seeds for metastases and are instrumental for the spread of the disease. Therefore the development of CTC-related applications is very important.

Analysis of CTCs may allow earlier detection of metastasis-capable malignancy when it is in a less invasive stage, and the ability to remove CTCs from circulation could potentially limit metastases after surgery. Many studies have shown that the presence of CTCs in peripheral blood and/or bone marrow is of prognostic significance in different types of solid tumors, and that CTC numbers also help monitor response to treatment. The current FDA-approved CTC analysis is based on immunological capture of CTC by magnetic beads. However, this method does not capture all types of CTCs and may be limited in its efficiency and accuracy. Hence it is important to develop improved methodologies for CTC detection, enumeration, isolation, and subsequent genetic or proteomic analysis. Moreover, the development of technologies that allow the efficient removal of CTCs from circulation could have therapeutic potential. This contract topic seeks to stimulate research, development, and commercialization of innovative devices and methodologies designed for Point of Care analysis of CTC-based diagnostics, prognosis, and treatment.

Project Goals:
The long-term goal of the project is to develop Point of Care (POC) devices and methods of CTC detection, enumeration, isolation, removal, and subsequent genetic and proteomic analysis for better cancer diagnosis, prognosis, and treatment. The major focus is to develop clinical tools rather than tools for basic research. In the long term, these tools should be developed as POC devices and must perform at a lower cost than current methodology or offer significantly improved sensitivities/specificities or new features such as predictive diagnostics or treatment management tools not available with current technologies. The short-term goal is to demonstrate the technical viability of the proposed approach to detect and/or isolate and/or eliminate CTCs in an experimental setting. Acceptable studies include but not limited to:

• CTC isolation and enrichment technologies such as magnetic separation, microfluidics, size separation and negative or positive selection.
• Surface antigen based CTC isolation and analysis.
• Viable CTC cell isolation and/or culturing for treatment assessment.
• CTC elimination from circulation.
• Scanning, imaging, flow cytometry technologies for CTC.
• Technologies to predict treatment and to monitor progress using CTCs.
• Non-separation based technologies for CTC.
• CTC detection, monitoring, or elimination using wireless devices.
• Other tools for CTC detection, enumeration, isolation, and analysis with clinical utilities.