DEVELOPMENT OF RAPID ASSAY FOR CREUTZFELDT-JAKOB DISEASE

Release Date:  May 19, 1999

REQUEST FOR INFORMATION:  NINDS-99-RFI-01

P.T.

NATIONAL INSTITUE OF NEUROLOGICAL DISORDERS AND STROKE 

The National Institute of Neurological Disorders and Stroke
(NINDS), NIH is seeking to identify sources that are interested
and have the potential capability to develop a reliable,
practical and rapid assay for sporadic and other variants of the
infectious agent of Creutzfeldt-Jakob disease (CJD), in tissue or
body fluids such as blood and cerebral spinal fluid.  Such an
assay could be used as a diagnostic tool once clinical signs
appear as well as for screening blood and tissue.  The
information requested below will aid in planning and developing a
possible solicitation for this potential initiative.   It is our
opinion that the most suitable target audience to respond to this
inquiry would be organizations engaged in prion research and
those who have or may be developing such an assay. 

Background

Creutzfeldt-Jakob disease (CJD) and related spongiform
encephalopathies are rare, fatal degenerative diseases of the
central nervous system characterized by rapid progressive
dementia, motor system dysfunction, and vacuolar degeneration of
the brain.

Although the incidence in the United States has remained stable
at 1 to 2 cases per million population per year, public and
scientific interest in CJD has been heightened in the last
several years by the epidemic of bovine spongiform encephalopathy
in the United Kingdom in temporal association with an unusually
high incidence of a progressive degeneration of the brain very
similar to, but distinguishable from, classical CJD, which has
been called new variant CJD (nv-CJD).  The identification of nv-CJD 
and its apparent increasing incidence has raised serious
concerns not only about the infectivity of blood and other body
fluids or tissue as a public health issue, but also about the
lack of a reliable, relatively rapid, assay for either the
transmissible agent, or a reliable marker of its presence.

The availability of a reliable practical assay for the infectious
agent of CJD in tissue or body fluids such as blood or cerebral
spinal fluid would be not only of clinical importance to permit
monitoring the infectivity of blood, and facilitating the early
clinical diagnosis of CJD, but also of research importance
because it could permit epidemiological study of classical as
well as new variant Creutzfeldt-Jakob disease and possibly permit
identification of other presently unrecognized variants. 

To aid in the design of a possible future solicitation, we ask
that interested organizations submit the following information
regarding your capabilities to accomplish the following:

Development of an assay that would permit detection of abnormal
isoforms of the prion protein or of suitable surrogate markers;
and capable of detecting and distinguishing between sporadic and
new variant CJD; How an assay might be validated as a measure of
infectivity; and How an assay could be made more reliable and
faster than existing assays, and also be made adaptable to
clinical pathological laboratories as well as research
laboratories.

This Request for Information (RFI) is for information and
planning purposes only and shall not be construed as a
solicitation or as an obligation on the part of the Government. 
The Government does not intend to award a contract on the basis
of responses nor otherwise pay for the preparation of any
information submitted or the Government's use of such
information.  Acknowledgment of receipt of responses will not be
made, nor will respondents be notified of the Government's
evaluation of the information received.  However, should such a
requirement materialize, no basis for claims against the
Government shall arise as a result of a response to this request
for information or the Government's use of such information as
either part of our evaluation process or in developing
specifications for any subsequent requirement.  Responses will be
held in a confidential manner.  Any proprietary information
should be so marked.  

All respondents are asked to indicate the type and size of your
business organization, e.g., Large Business, Small Business,
Hubzone Small Business, Small Disadvantaged Business, Women-Owned
Business, 8(a), Historically Black College or University/Minority
Institution (HBCU/MI), educational institution, profit/non-profit
hospital, or other nonprofit organization. 

Responses should be identified with NINDS RFI No. 99-01, and are
due by June 15, 1999.  Please submit three (3) copies of your
response, not to exceed 5 pages, to the attention of: Kirkland L.
Davis, Contracting Officer, Contracts Management Branch, National
Institute of Neurological Disorders and Stroke, NIH, 6001
Executive Boulevard, Room 3287, MSC 9531, Bethesda, Maryland
20892-9531.  Facsimile responses will also be accepted as long as
they do not exceed 5 pages in length.  E-mail responses, sent to
[email protected], will also be accepted. 

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