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242 Biosensors for Early Cancer Detection and Risk Assessment

Number of anticipated awards: 3
(Fast-Track proposals will be accepted.)
Budget (total costs): Phase I: $150,000;
Phase II: $1,000,000

The deadline for receipt of all contract proposals submitted in response to this solicitation is: 5:00 p.m. Eastern Standard Time Monday, November 5, 2007

A primary cause of poor survival rates from cancer is that many cancers are detected late, after they have spread or metastasized to distant sites. For most types of cancer, the earlier the detection the greater the chances of survival. For example, when colorectal cancer is detected in its earliest stages, the 5-year survival rate is as high as 95%, but if detected after it has spread, the survival rate is less than 10%. Five year survival rates for cancers where screening tools are available are 4-6 times greater than for cancers for which there are no viable screening tools. However, even for cancers where screening tools currently exist, there is room for improvement in the accuracy of the tests or in making them more acceptable to patients. Consequently, there is a need to develop methods to noninvasively and accurately detect cancers at early stages of development and to determine those individuals at increased risk of developing cancer. Given the heterogeneity of transformed cells found in many tumors, it is unlikely that a single biomarker will be able to provide sufficient sensitivity and specificity to be useful as an early detection screening assay. Thus, there is a need for devices that can accurately and reproducibly measure multiple cancer biomarkers or circulating tumor cells in bodily fluids or other specimens obtained by minimally invasive methods. As these biomarkers or tumor cells are likely to be present in low abundance, the device must be very sensitive. Biosensors have the potential to fulfill this need.

Project goals:

The purpose of this solicitation is to develop biosensors for early cancer detection and risk assessment. Biosensors are bioanalytical devices that combine biochemical recognition or binding elements, physicochemical transducers, and readout modalities. Biochemical recognition elements include antibodies, proteins and peptides, nucleic acids, aptamers, cell receptors, enzymes, and tissues. The transducer may be optical, electrochemical, thermometric, piezoelectric or magnetic. Biosensors for early cancer detection and risk assessment have potential advantages over other analytical methods including the capability for multi-target analyses, automation, speed, flexibility and reduced costs. Given the complexity of biological specimens, it may be necessary to incorporate front end sample preparation.

Phase I activities and expected deliverables:

• Design novel biosensors or improve existing biosensor technologies that can be used either to measure physiological concentrations of multiple known biomarkers for early cancer detection or risk assessment or to capture and measure circulating tumor cells.
• Perform analytical validation (e.g., accuracy, reproducibility, sensitivity, specificity and dynamic range) using purified samples in an artificial matrix that mimics the clinical specimens.
• Demonstrate flexibility to allow measurement of new biomarkers to be incorporated or substituted as they become available.

Phase II activities and expected deliverables:

• Complete the development and automation of the biosensor and demonstrate its speed, flexibility, and ability to reduce costs.
• Perform analytical validation (e.g., accuracy, reproducibility, sensitivity, specificity and dynamic range) using appropriate patient specimens (e.g., urine, sera, plasma, or sputum).
• Determine clinical sensitivity and specificity.

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