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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