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236 Antibody Array for Cancer Detection

Number of anticipated awards: 3-5
(Fast-Track proposals will not 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

The purpose of this initiative is to develop high throughput antibody arrays for quantitative analysis of multiple biomarkers for early detection and diagnosis of cancer. These arrays may include antibodies based on the applicant's own research and knowledge of the literature. Applicants are also encouraged to contact extramural investigators from the NCI's Early Detection Research Network (EDRN; www.cancer.gov/edrn), which is developing a number of biomarkers for cancer detection, diagnosis and prognosis. Please contact one of the members or associate members at: http://edrn.nci.nih.gov/memberslist/x.xml. The selected applicants will develop microarrays, the chemistry of which may be based on nanotechnology and/or microfluidics. Applicants should focus initial development on the diagnosis and early detection of prostate, breast, lung, colon, and other major epithelial cancers. In Phase II, the antibody microarray developed in Phase I will be validated under a plan developed with the NCI project officer. Applicants are encouraged (but not required) to develop a validation plan that includes the participation of EDRN investigators. It is anticipated that such participation will result in accelerated development, production, validation and commercialization of antibody microarray technology for early detection and diagnosis of cancer.

Project goals:

  • Prepare and purify biomarker-specific antibodies in the form of recombinant antibodies or monoclonal antibodies (mAb) and construct arrays.
  • Develop and/or improve methodologies for quantitative measurements of the bound antigens on Ab microarrays.
  • Perform analytical validation, e.g., test the reproducibility, sensitivity, specificity and dynamic range of detection in collaboration with EDRN and other institutions to measure the efficacy of the developed array.

Currently, there is no single marker or a combination of biomarkers that has sufficient sensitivity and specificity to diagnose early stage cancer. However, recent developments in gene and proteomic profiling of precancerous and cancerous lesions suggest that a combination or a patterns of markers may be used to distinguish between cancer and non-cancer with high sensitivity and specificity (95-100%). Innovative technologies, such as microfluidics and nanotechnology, combined with antibody arrays are likely to provide a reliable, sensitive and quantitative detection tool for measuring differentially expressed biomarkers from a limited amount of sample (20ul or less of serum). The involvement of small businesses through the SBIR contract mechanism will strengthen the EDRN's efforts in the development, validation and commercialization of biomarkers for early detection and risk assessment.

The work performed under this contract is between a selected Biotech Company and EDRN Investigator/s and the NCI EDRN Program staff. Unless otherwise agreed to in writing between the selected Biotech Company and the institutions of the EDRN, the following will guide the Intellectual Property management and sharing of research resources generated from the work performed under this contract. All inventions conceived or first actually reduced to practice solely by the selected Biotech Company investigators under this Agreement will be the property of the selected Biotech Company in accordance with 35 USC Section 200, et. seq., subject to any intellectual property (IP) rights of the providers of biomarkers (e.g., institutions of EDRN investigators) to the selected Biotech Company. All inventions conceived or first actually reduced to practice jointly by the selected Biotech Company and any EDRN Investigators or NCI EDRN program staff will be jointly owned by the inventors' institutions. The Selected Biotech Company agrees that it will permit EDRN Investigators to use such inventions under terms consistent with the Principles for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical research Resources (http://grants.nih.gov/grants/intell-property_64FR72090.pdf).

The providers of biomarkers will retain their respective IP rights for those biomarkers developed by their institution's respective investigators. The selected Biotech Company is responsible for negotiating access rights, including any commercial license rights, to all materials provided to the selected Biotech Company, and any related IP, in order to conduct the activities funded under this Agreement.

NCI, EDRN Investigators and the EDRN Data Management and Coordinating Center, managed by the Fred Hutchinson Cancer Research Center ("EDRN DMCC") will have unlimited rights as defined in FAR 52.227-14, general to the following data developed during the course of this project: (i) protocols for using the antibody microarrays to be developed by the selected Biotech Company and individual antibodies independent of the antibody arrays; (ii) initial research results concerning the use of antibodies against specimens provided by EDRN Investigators; (iii) antibody characterization data, including the results of testing to demonstrate the utility of particular antibodies; and (iv) validation data based on subsequent experiments involving the antibody microarrays.

Authorship of publications resulting from data developed under this contract will be shared by all contributing parties including the NCI.

Phase I Activities and expected deliverables:

Relevant biomarkers could be selected from published literature or by contacting one of the EDRN extramural investigators. (Please contact one of the members or associate members at: (http://edrn.nci.nih.gov/memberslist/x.xml.)

  • Establish the proof of principle.
  • Develop an antibody microarray for detection of 3 biomarkers using innovative technologies.
  • Demonstrate that the tiled antibodies perform as well or better than a conventional ELISA in the detection of these biomarkers in serum from cancer patients.

Phase II Activities and expected deliverables:

Applicants are encouraged (but not required) to develop a validation plan that includes the participation of EDRN investigators.

  • Develop antibody microarrays with a capability to simultaneously detect and measure the concentration of 30-50 biomarkers. These arrays can include both biomarkers from the EDRN as well as biomarkers identified by the small business.
  • Validate antibody microarrays in high-risk subjects.
  • Produce and test up to 1000 microarrays with samples from normal and case subjects.

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