SBIR-STTR Award

A Systematic Approach to Early Diagnosis of Cancer
Award last edited on: 12/28/18

Sponsored Program
SBIR
Awarding Agency
NIH : NCI
Total Award Amount
$381,535
Award Phase
2
Solicitation Topic Code
-----

Principal Investigator
David H Beach

Company Information

Genetica Inc

One Kendall Square Building 600
Cambridge, MA 02139
   (617) 621-1222
   N/A
   N/A
Location: Single
Congr. District: 07
County: Middlesex

Phase I

Contract Number: 1R43CA083603-01
Start Date: 9/20/99    Completed: 4/30/03
Phase I year
1999
Phase I Amount
$128,226
One of the undisputed keys to the successful treatment of cancer is early diagnosis. This strongly argues for participation in routine screening programs. However, those that are in place currently suffer from significant drawbacks. A major thrust of applied cancer research in the coming years will be a search for improved diagnostic methodologies. One route toward the design of new surveillance methods is the identification of markers that are characteristic of tumor cells. The foundation of the proposed research is two-fold. We will use the Genetica trap technology to sift libraries prepared from colon, breast and prostate carcinomas for genes encoding trafficked proteins. Thereafter, we will use "off-the-shelf"technologies to assess differential expression of such genes in normal and tumor cells. These studies will lead to the creation of libraries of tumor-specific genes that encode secreted and cell surface proteins. These will be used to generate immunological reagents to analyze blood born and cell surface markers in order to identify proteins that are diagnostic of early stage tumors. PROPOSED COMMERCIAL APPLICATIONS: There are a multitude of commercial applications for the proposed research. Primary is the identification of blood-borne, tumor specific proteins that can be used for the development of routine diagnostic tests. In addition, we may identify potential targets for tumor imaging agents. Finally, tumor-specific receptors may be provide starting points for the development of small-molecule anti-tumor drugs or biotherapeutics.

Thesaurus Terms:
early diagnosis, gene expression, genetic marker, neoplasm /cancer diagnosis, nucleic acid sequence breast neoplasm, colon neoplasm, diagnosis design /evaluation, prostate neoplasm genetic library, tissue /cell culture

Phase II

Contract Number: 2R44CA083603-02
Start Date: 00/00/00    Completed: 00/00/00
Phase II year
2002
Phase II Amount
$253,309
Prostate cancer is the second leading cause of cancer death in men, killing approximately 32,000 men annually. An urgent need exists for improved diagnostic and prognostic tools. PSA tests are widely used diagnostic tools, but they yield an unacceptable degree of false positives and false negatives. Due to a lack of prognostic tools, many men undergo unnecessary, radical treatments. We describe herein a systematic program for the discovery of secreted prostate tumor biomarkers. In Phase I, we developed a ?secretion trap?, a protocol for rapid isolation of a library of secreted sequence tags from any source. Since a ?trapped? library identifies accessible proteins, e.g. cell surface and extracellular proteins, it is a powerful means for discovering biomarkers with diagnostic and prognostic potential. We will generate a library of secreted sequence tags from prostate tumors and we will choose 100 that fulfill basic criteria required of useful biomarkers. We will determine the expression profiles of the candidate markers by automated, high-throughput in situ hybridization and immunohistochemistry. Finally, we will determine whether any of these biomarkers are present in the serum of patients with prostate cancer. These experiments will identify biomarkers that may be commercialized as diagnostic or prognostic indicators.

Project Terms:
biomarker; biomedical automation; clinical research; diagnosis design /evaluation; early diagnosis; gene expression; genetic library; genetic markers; high throughput technology; human subject; immunocytochemistry; in situ hybridization; male; neoplasm /cancer diagnosis; nucleic acid sequence; oncoproteins; prostate neoplasms; tissue /cell culture