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287 Nanotechnology Sensing Platforms for Improved Cancer Detection

Number of anticipated awards: 3

(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:
Nanotechnology allows for the design and manufacture of complex multi-functional devices which could lead to the miniaturization of biological assays. Current diagnostic assays require a patient visit a physician or travel to a laboratory. Nanotechnology-based instruments hold the potential for point-of-care applications where assays could be conducted by the primary care physician in their office or by the patient in their home as well as by health care workers in remote geographical locations or in hospitals for bed-ridden patients. Additionally, these systems require much smaller volumes of sample for analysis than conventional assays thus reducing the cost associated with reagents and the time required for conducting of some of these assays (e.g., heating and cooling in PCR-based assays).

For several types of cancer, the primary cause of poor survival is late detection, almost often after the disease has spread to distant sites. For example, most melanomas that are found without evidence of metastasis can be cured with surgical resection. In contrast, for the patients with advanced or metastatic melanoma, the prognosis is poor (a 5-year survival of 5-10%). Consequently, efforts are currently being made to develop new early-stage diagnostic solutions relying on highly sensitive and specific devices and the use of prognostic biomarkers.

To accelerate such efforts, the National Cancer Institute (NCI) requests proposals for the development of commercially viable nanotechnology-based diagnostic platforms that will ultimately assist and improve current clinical protocols of cancer detection and diagnosis.

Project Goals:
The goal of the project is to develop nano-enabled diagnostic platforms that can provide increased sensitivity and specificity in recognizing cancer that would ultimately offer clinicians a way to maximize the chance of positive clinical prognosis. The platforms can be used for early detection of initial onset of disease, or be used as post-treatment monitoring to detect recurrence of disease. Strategies can also include screening assays that provide a better understanding and prediction of metastasis which can help develop better therapies and further improve patient outcome. As current drug development continues to rely mainly on reductions in overall size of tumors, many validated compounds may not be effective for eradication of metastatic disease.

Potential relevant sensing nanoplatforms could include, but are not limited to:

Nano-enabled Sensing Platforms for in vitro Applications
Examples: Use of functionalized nanomaterials (nanowires, nanotubes, nano-cantilevers, etc.) to develop diagnostic platforms with optical or electrical output.

Potential Applications: Novel platforms that would enhance sensitivity/specificity of existing candidate biomarker detection and validation; Sensing of tumor metastasis and/or recurrence post-treatment; detection, isolation and/or evaluation of circulating tumor cells (CTCs).

Nano-enabled Sensing Platforms for ex vivo Applications
Examples: Use of functionalized nanomaterials introduced into patient organism and subsequently collected for ex vivo ascertaining of biochemical, metabolic and/or pharmacological data regarding tumor status or therapeutic efficacy.

Potential Applications: Long-term monitoring of treatment effectiveness, determination of therapeutic efficacy, monitoring tumor metastasis.

High throughput Screening Nanoplatforms
Examples: Nanotechnologies (using nanopatterning, imaging agent, sensing platform, microfluidics) for highly parallel, high throughput assay development.

Applications: Identifying and detecting novel cancer biomarkers that may be undetectable using traditional assays; detecting cellular changes using nano-sensors to screen for novel therapeutic agents.

Given the diversity of potential applications discussed above, submitted proposals should place emphasis on the specific nanotechnology-enabling component of the proposed platform.

Phase I activities and expected deliverables:
  • Design describing:
    • Unique temporal capabilities enabled by nanotechnology.
    • Proof of concept experiments.
    • Benchmarking experiments against conventional methodologies.
  • First-stage validation of design in relevant preclinical samples,
    • In vitro sensing platforms: Candidate biomarkers in serum-free samples.
    • In vivo sensing platforms: Candidate biomarkers in cell culture.
    • High throughput screening assays: Non-primary cell lines and/or tissue samples.
  • Successful completion of benchmarking experiments demonstrating a minimum of 2x improvement against conventional methodologies.

Phase II activities and expected deliverables:
  • Second-stage validation of design for potential clinical adaptation.
    • In vitro sensing platforms: Candidate biomarkers in patient samples.
    • In vivo sensing platforms: Candidate biomarkers in animal models.
    • High throughput screening assays: primary cells and/or tissues obtained from patients.
  • Submitted IDE application to obtain necessary regulatory approval for clinical validation.

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