A Recent Announcement from the Federal Register


DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

National Institute of Neurological Disorders and Stroke: Opportunity for a
Cooperative Research and Development Agreement (CRADA) for the Development of a High Performance Gene Expression Mapping Assay System

AGENCY: National Institutes of Health, PHS, DHHS

ACTION: Notice

SUMMARY: The National Institutes of Health (NIH) seeks an agreement with a
company(ies) which will collaborate on the development of an automated high
capacity, high resolution cellular gene mapping assay system for mRNA
expression analysis system or genomic fingerprinting.

ADDRESS: Questions concerning scientific aspects of this opportunity may be
addressed to Roland Somogyi, Ph.D., National Institutes of Health, NINDS, 9000
Rockville Pike, Building 36, Room 2C02, Bethesda, MD 20892. Telephone:
301-402-1407, or e-mail: ROLANDS@HELIX.NIH.GOV

Business questions should be addressed to Stephen Finley, Ph.D., National
Institutes of Health, NINDS, 9000 Rockville Pike, Building 31, Room 8A46,
Bethesda, MD 20892. Telephone: 301-496-4697, or e-mail: SF31W@NIH.GOV

DATES: Proposals should be received by (60 days from FR publication date).

SUPPLEMENTARY INFORMATION

The Laboratory of Neurophysiology (LNP) studies the cellular function and
processes of normal and abnormal nerve cells. The over- and under-expression
of genes play critical roles in the control of cellular function,
proliferation, and differentiation, and are responsible for a number of
neurodegenerative disorders and hyperplasias. The LNP developed a
quantitative reverse transcription polymerase chain reaction based protocol
which optimizes the identification of over- or under-expression of genes in a
cell. A library of primers for over 100 different signaling genes have been
successfully used to screen expression patterns in nerve cells.

Current cellular gene expression research is hampered by the time required for
sequential analysis of the expressed genes in a cell. There is no fully
automated high capacity, high resolution assay system developed for gene
expression mapping (GEM).

An assay system which analyzes the expressed genes in cells will provide a new
opportunity for exploring how environmental or genetic changes alter the
cellular expression of genes. The significance of such a system is that it
allows cascade effects of a single event to be analyzed in toto, as contrasted
to being limited to the study of the effect on a single gene. This new
approach will refine the study of cellular signaling processes and open the
field of experimental genetic networks. The study of genetic networks
represents a frontier which will provide insight into complex interactions
between genes. This is becoming a necessity since many current findings
cannot be understood in terms of a single gene acting in isolation.

The LNP would like to collaborate in developing an automated system for the
laborious gene expression assay process which incorporates sample preparation,
reverse transcription polymerase chain reaction, thermal cycling, and high
speed analysis of the final product. The aim of this CRADA is to produce an
automated system which breaks through the current technological barriers and
ultimately enables the cataloging of the expression levels of all genes in a
cell type. The culmination of this CRADA could provide a means to
simultaneously screen the mRNA variations in a multitude of cell types or
provide a means for the genomic fingerprinting of cellular DNA.

Role of NINDS:

1. The LNP will provide its expertise in the quantitative reverse
transcription polymerase chain reaction (RTPCR) protocol it developed as well
as a custom library of primers for over 100 different genes.

2. Collaborate in designing instrumentation adapted for high volume, high
resolution gene expression analysis.

3. Collaborate in the formulation, evaluation, optimization of experimental
protocols based on the quantitative RTPCR protocols identified above.

The role and criteria for selection of the successful company(ies) under the
CRADA will include, but may not be limited to, the following:

1. Having an established ability to design, manufacture or modify in one or
more of the following: thermocycling devices, capillary electrophoresis
devices, automated detection systems (i.e., fluorescence or chromophoric) and
laboratory robotics.

2. Ability to provide appropriate instrumentation either owned by the company
or obtained through third party licensing agreements.

3. Ability to market and sell the final product produced through the
collaboration.