Profiling EGFR and Her2 in Breast Cancer using Multiplex Tissue Immunostaining

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: 1R43CA123994-01A2
Agency Tracking Number: CA123994
Amount: $117,930.00
Phase: Phase I
Program: SBIR
Awards Year: 2007
Solicitation Year: 2007
Solicitation Topic Code: N/A
Solicitation Number: N/A
Small Business Information
DUNS: 136134686
HUBZone Owned: N
Woman Owned: Y
Socially and Economically Disadvantaged: Y
Principal Investigator
 (301) 435-7882
Business Contact
Phone: (240) 453-6339
Research Institution
DESCRIPTION (provided by applicant): We propose to develop a novel method and kit for profiling the expression and activation of signal transduction proteins in breast tumors. The goal is to create new "companion" diagnostics to better select patients likely to respond to targeted therapies, including Herceptin(r) and novel tyrosine kinase inhibitors. 20/20 will utilize its proprietary layered peptide array (LPA) technology. Transfer of antibody probes from a single tissue section to numerous bioaffinity membranes permits multiple target antigens (up to 50 if needed) to be assessed in a quantitative manner while preserving the local spatial orientation of the targets relative to the tissue section. The immediate goals are to develop a panel of 7 assays (comprising antigen-coated membranes and relevant antibodies), and to demonstrate their use for profiling AKT signaling in cultured breast cancer cells and archival tissues. During Phase II, we will demonstrate its tissue applications with animal models, and with human breast tissue sections from clinical trials in breast cancer patients treated with growth factor and Akt inhibitors. The product would have utility in both a research and clinical laboratory setting. Importantly, the system is open-ended to the addition of new prognostic markers and drug targets into the assay panel. There are several anticipated advantages of the layered membrane platform over current histopathology tools such as immunohistochemistry (IHC). These include conservation of tissue (such as for core needle biopsies) and the ability to simultaneously profile multiple signaling proteins in both normal and phosphorylated form. Our options for breast cancer diagnosis and treatment will increasingly take advantage of information obtained from tumor profiling assays, which will indicate customized therapies for each form of the disease. The novel diagnostic techniques to be researched will allow for microscopic profiling of tiny amounts of tissue for numerous cancer-causing molecules. There will be applications in pre-clinical studies and drug trials, which will aim to invent novel treatment strategies using combinations of drugs that block 'growth factor' molecules.

* information listed above is at the time of submission.

Agency Micro-sites

SBA logo
Department of Agriculture logo
Department of Commerce logo
Department of Defense logo
Department of Education logo
Department of Energy logo
Department of Health and Human Services logo
Department of Homeland Security logo
Department of Transportation logo
Environmental Protection Agency logo
National Aeronautics and Space Administration logo
National Science Foundation logo
US Flag An Official Website of the United States Government