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Technology Development for the Detection and Evaluation of Chemical and Biological Carcinogens



This Funding Opportunity Announcement (FOA), issued by the National Cancer Institute (NCI), at the National Institutes of Health (NIH), invites Small Business Innovation Research (SBIR) grant applications from small business concerns (SBCs) propose to develop new technologies and/or improve existing technologies for the detection and evaluation of chemical and biological carcinogens in clinical and/or environmental specimens. These technologies should be amenable to automation and high sample throughput. The ultimate goal of this initiative is to develop innovative carcinogen detection technologies to the stage of commercially viable assays.


Robust and high throughput in vitro and in vivo assays that measure the presence and/or concentration of known or suspected biological or chemical carcinogenic agents are essential to establish associations between agent exposure and the development of disease in humans. Current technologies in these areas are often limited in sample throughput. Also, the cost of accurate and sensitive detection (e.g., exposure to known and suspected carcinogens) may be prohibitively high for wider application. Improved and novel technologies and assays are particularly needed to support basic research needs that are pertinent to the analyses of (1) known and suspected carcinogenic agents by directly measuring the agents (for the detection, quantification, and validation of carcinogenic properties), (2) the molecular processes/markers of key carcinogenic pathways and/or (3) the emergence of cancer cells as the ultimate carcinogenic outcome. Ultimately, advances in carcinogen detection technology may have multiple impacts on public health care and have market potential beyond basic research laboratories.

For the purpose of this FOA, the term technology encompasses methods and tools that enable research, including but not limited to, instrumentation, techniques, software, and devices.

Specific Objectives

Applications submitted in response to this FOA are encouraged to focus on novel means and technologies to measure carcinogenic agents, exposure to carcinogens, and/or carcinogenic outcomes. This announcement encourages development of innovative technologies that may include the use of animal models, in vitro cell cultures, or cell-free systems. Of particular interests are assays/tools/devices that enable high sample throughput and multiplex assays (or are adaptable for such uses). Plans for technology/assay development may propose the use of various instrumental endpoints that can be translated to an automated format, such as absorbance, fluorescence, luminescence, scintillation proximity assay (SPA), fluorescence resonance energy transfer (FRET), bioluminescence resonance energy transfer (BRET), flow cytometry, and cell based imaging. In general, assays proposed for development should be easy to execute (for example, assays requiring only simple addition of reagents; using multi-well plate formats; and/or other formats allowing for multiplexed readout). The goal of the research proposed should be to develop technologies/assays that are robust and reproducible and, eventually, adaptable to full automation.

Examples of specific research interests in the context of developing new assays or enhancing existing assays include (but are not limited to) the following areas:

  • Detection of oncogenic viruses and/or bacteria in experimental, environmental and/or clinical samples (especially easily obtainable biological fluids);
  • Detection of oncogenic chemicals in experimental, environmental or clinical samples (especially easily obtainable biological fluids);
  • Detection of oncogenic contaminants in food, food components, and beverages;
  • Detection/quantification of metabolic activation of procarcinogens;
  • Assays using mammalian or non-mammalian systems to specifically distinguish likely human oncogenic agents from broadly mutagenic agents;
  • Mutagenic/genotoxic assays pertinent to mammalian carcinogenesis (using either mammalian or non-mammalian models);
  • Serological detection of Kaposis Sarcoma Herpes Virus;
  • Detection of pre-cancerous cellular markers reflecting DNA damage and/or stress conditions (e.g., formation of DNA adducts, oxidative damage to nucleic acids, lipids, or peptides/proteins); and
  • Identification of cellular markers that can be used to assess carcinogen exposure

Note: This FOA is not intended to support clinical diagnostic assays, assays to assess therapeutic outcomes, as well as any drug development efforts, including small molecule library screens in the therapeutic context.

Small business applicants interested in the development of technologies and software to support integrative cancer biology are encouraged to consider another related initiative entitled Technologies and Software to Support Integrative Cancer Biology Research (SBIR) [R43/R44] (PA-09-188)

Small business applicants interested in the development of innovative technologies for assaying carcinogenesis-relevant molecules are encouraged to consider a concurrent initiative entitled Technology for the Detection and Characterization of Low Abundance Proteins, Peptides, or micro RNAs (SBIR) [R43/R44] (PA-09-189).

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