DEVELOPMENT OF NOVEL TECHNOLOGIES TO SUPPORT CANCER RESEARCH
NIH GUIDE, Volume 26, Number 6, February 21, 1997
P.T. 34
Keywords:
Cancer/Carcinogenesis
Nucleic Acids
Biotechnology
National Cancer Institute
Annual 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 this
research topic, development of novel technologies to support cancer
research, to the Technology Development Branch of the Cancer
Diagnosis Program, Division of Cancer Treatment, Diagnosis and
Centers (DCTDC), National Cancer Institute (NCI), National Institutes
of Health (NIH). 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 two areas: the generation of
representational full length cDNA libraries and the development of
high throughput technologies for analysis of the spectrum of
molecular alterations in primary tumor tissues. Investigators may
propose projects to develop and/or to implement one of these
technologies. Ultimately the technologies or resources developed
with the technologies must be commercially viable and preferably
useful within a clinical setting.
Through the Small Business Innovative Research (SBIR) and Small
Business Technology Transfer (STTR) mechanisms, 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
The rapid increase in our understanding of tumor biology coupled with
the technology and data emerging from the human genome project, offer
the opportunity for a change in the way cancer research is done. It
is becoming clear that cancer is not a single disease but many, and
that cancers arise from the gradual accumulation of genetic changes
in single cells. It is not clear which changes and how many changes
are required to cause a cancerous state. Technologies that make
possible the evaluation of multiple alterations in tumor tissue at
the level of DNA, RNA or protein will facilitate the identification
of genes involved in cancer and will provide diagnostic and
prognostic information useful for cancer patient management. This
notice is intended to encourage technology development projects in
the following two categories: representational, full length cDNA
libraries and high throughput technologies for analysis of the
spectrum of molecular alterations in primary tumor tissues
Representational, Full-Length cDNA Libraries:
Current technology for generating cDNA libraries allows the
production of representative libraries of partial genes or production
of more limited libraries of full length clones, which are generally
enriched for shorter genes. In addition, technology exists to create
normalized (reduced redundancy) cDNA libraries. However, it is not
currently possible to efficiently generate representational libraries
of full length cDNAs. In order to derive the maximum benefit from
existing libraries and to find expressed genes not present in
existing libraries, new technologies for generating full length
representational cDNA libraries are necessary.
Investigators may propose to develop the novel technologies for
generating these libraries or, if they have existing, proven
technologies for this purpose, they may propose to generate
appropriate libraries using their existing technology. Approaches
for demonstrating that the clones in the libraries encode the entire
sequence of the mRNA from which they were derived and contain a
representative sample of the original mRNA population of the selected
tissue must be described. Investigators may also propose to develop
technologies for generating libraries which are enriched for genes
differentially expressed from appropriate tissues. Appropriate
tissues are those which will provide information about gene
expression during cancer initiation and/or progression. In all
cases, the end result must be a technique or a resource which can be
made into a commercially viable product. For example, applicants
applying through the STTR mechanism may propose to move technology
previously developed at an academic institution to a small business
for the purpose of producing specific libraries. Applicants applying
through the SBIR mechanism may propose, for example, to develop novel
technologies for the construction of the cDNA libraries and to
commercialize either the methodology or the resulting libraries. The
most desirable technologies will be those which are adaptable to
high-throughput systems.
High-Throughput Analysis of Tissue Samples:
Previous studies designed to correlate molecular alterations in
tumors with clinical parameters have suggested the potential
importance of measuring these changes as a part of clinical
decision-making. The sequencing of the human genome and ongoing
development of technologies to analyze genetic alterations on a
genome-wide scale may soon make it feasible to simultaneously
evaluate all or a subset of the nucleic acid alterations in tumor
tissue. Similar technologies to detect patterns of protein
expression or to detect changes in proteins functioning in pathways
of cellular regulation are also needed. The continuing development
of both nucleic acid and protein based technologies will facilitate
the discovery of new alterations in tumor cells and, ultimately, the
rapid collection of diagnostic and prognostic information that may be
useful in cancer patient management.
Investigators should propose development of nucleic acid or protein
based technologies and studies to assess their use in analysis of
primary tumor specimens. They may propose to develop a
high-throughput technology to characterize cancers at the molecular
level, to modify existing technologies for use in a clinical setting,
or to commercialize technologies that currently exist only in a
laboratory setting. For example, applicants applying through he SBIR
mechanism might develop a high-throughput technology then collaborate
with an academic institution to procure appropriate tissue samples
for validation of their technology on clinical specimens. Applicants
applying through the STTR mechanism might propose to move
technologies developed in an academic setting for the high-throughput
screening of tissue samples into the development of commercial kits
or devices. Technologies may be designed to analyze a variety of
alterations including genome-wide cytogenetic changes; mutations in
constellations of genes known to be important in tumor initiation and
progression, including genes that are members of pathways of cellular
regulation; analysis of all possible mutations in a single gene;
changes in patterns of gene expression at the level of both RNA and
protein; or changes in protein function. Development of sample
preparation technologies and/or informatics systems to support
collection and evaluation of research data may also be proposed.
INQUIRIES
Inquiries are encouraged. The opportunity to clarify any issues or
questions from potential applicants is welcome.
Direct inquiries regarding programmatic issues to:
Jennifer Couch, Ph.D.
Division of Cancer Treatment, Diagnosis and Centers
National Cancer Institute
6130 Executive Boulevard, Room 513, MSC 7388
Bethesda, MD 20892-7388
Telephone: (301) 496-1591
FAX: (301) 402-1037
Email: couchj@dcbdcep.nci.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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