DEVELOPMENT OF HIGH THROUGHPUT ASSAYS FOR EXFOLIATED CELLS IN TUMOR DETECTION (SBIR/STTR) Release Date: June 19, 1998 P.T. National Cancer Institute: Application Receipt Dates: April 1, August 1 and December 1 for STTR April 15, August 15, and December 15 for SBIR PURPOSE The purpose of this notice is to emphasize the importance of the above research topic to the Early Detection Branch, Division of Cancer Prevention (DCP), National Cancer Institute (NCI), National Institutes of Health (NIH). The focus is on the development of high throughput, sensitive assays or technologies for the detection of exfoliated cells in body fluids, such as serum, stool, sputum, urine, brochioalveolar lavage, pancreatic juice, and breast nipple aspirates. This research topic is of special interest to the NCI, NIH, and is identified in the Omnibus Solicitation of the National Institutes of Health for SBIR Grant Applications (PHS 97-2) on pages 64-65. This notice is intended to encourage projects that propose development of technologies in detection and molecular characterization of tumor cells in body fluids. In pursuit of these goals, the NCI invites applications that address, but are not necessarily limited to, the following research areas exploiting molecular and genetic changes in tumor cells for early cancer detection: (1) Development of technologies for identifying abnormal exfoliated cells in body fluids, including the development of sampling technologies for capturing and preserving exfoliated tumor cells in body fluids and the development of enrichment methods for the isolation of tumor cells and tumor cell-associated macromolecules, and (2) Development of standardized sensitive, high throughput assays for the detection of molecular and genetic abnormalities, such as somatic mutations, clonality, RNA expression patterns, protein alterations, and evidence of other genomic instability in exfoliated cells. A collaborative approach among academic and industry leaders is strongly encouraged to advance translation research coupled with the development of relevant detection technologies and complex information integration into clinical settings aimed at early detection. Through the Small Business Innovative Research (SBIR) and Small Business Technology Transfer (STTR) mechanisms (R41/R43/R42/R44), small businesses can receive funding for early phase development of innovative technologies and proof of principle studies leading toward commercialization of these technologies. The solicitations are available electronically through the NIH, Office of Extramural Research "Small Business Funding Opportunities" home page located at http://grants.nih.gov/grants/funding/sbir.htm. In addition, a limited number of hard copies of the solicitations have been produced. Subject to availability, they may be obtained from the PHS STTR/SBIR Solicitation Office, phone (301) 206-9385; fax (301) 206-9722; Email: a2y@cu.nih.gov. RESEARCH OBJECTIVES Most cancers are clonal and of epithelial origin. During the progression of epithelial tumors, cells are often shed into the sputum in lung cancer, into the stool in colorectal cancers and into the urine in urinary tract cancers. Currently, it is difficult to detect epithelial cancer cells by routine cytopathological examination because of their low numbers and the lack of sensitivity. The sensitivity of cytopathological examination for the detection of tumor cells is in the range of 1 tumor cell per 10 to the 3rd to 10 to the 5th total cells. However, with the advent of new technologies, sensitivity may be substantially enhanced. For example, polymerase chain reaction (PCR) based amplification technologies have been introduced as sensitive tests for the detection of rare cancer cells in peripheral blood, lymph nodes, and other biologic fluids or aspirates. However, present technologies are too cumbersome to be of practical population-based utility. The most common limitations are lack of sensitivity and specificity suitable for small specimens like exfoliated cells; that they are laboratory-based and not yet tested in clinical settings; that they are time-consuming, and that they are not practical in screening a large number of subjects. Additionally, exfoliated cells are frequently contaminated with normal cells, bacteria, and other cellular debris making molecular analysis difficult without further physical separation and enrichment of neoplastic cells. Given that the frequency of these cells can be very low compared to other commonly present cell types one needs enrichment factors of 1 to 10,000 or 1 to million. Therefore, the development of novel, high throughput, sensitive technology for sample preparation and for molecular analysis is a prerequisite for the successful detection of the small number of exfoliated cells or small amounts of subcellular materials cells in biological fluids. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Sudhir Srivastava, Ph.D., M.P.H. Division of Cancer Prevention National Cancer Institute 6130 Executive Boulevard, Room 330F, MSC 7346 Bethesda, MD 20892-7388 Telephone: (301) 496-3983 FAX: (301) 402-0816 Email: ss1a@nih.gov Direct inquiries regarding fiscal matters to: Ms. Kathleen Shino Grants Management Office National Cancer Institute 6120 Executive Boulevard, Room 243 Bethesda, MD 20892-7150 Telephone: (301) 496-7800, ext. 248 FAX: (301) 496-8601 Email: ks48e@nih.gov
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