DEVELOPMENT OF ASSAY FOR CREUTZFELDT-JAKOB DISEASE

Release Date:  August 2, 1999

RFP Available: NIH-NINDS-BAA-RFP-99-11 

National Institute of Neurological Disorders and Stroke 

The National Institute of Neurological Disorders and Stroke (NINDS), in
collaboration with The National Heart, Lung, and Blood Institute (NHLBI), NIH
announces the availability of a Broad Agency Announcement (BAA) to support the
development and validation of a reliable, practical and rapid assay for the
sporadic, genetic and iatrogenic forms of the infectious agent of
Creutzfeldt-Jakob disease (CJD), in tissues or body fluids such as blood and
cerebral spinal fluid. The availability of a reliable, rapid, and practical
assay for the infectious agent of CJD in tissue or body fluids such as blood,
blood components including lymphoid cells or cerebral spinal fluid would be of
clinical importance to permit monitoring for the presence of infectivity in
humans thereby ensuring the integrity of the donor blood supply as well 
as facilitating the early clinical diagnosis of CJD.  Early detection and
monitoring of asymptomatic individuals carrying mutations on the prion protein
gene would permit efforts to prevent the disease and also aid in the
development of therapeutic regimens.  The existence of an assay would also be
of research importance because it could permit epidemiological study of the
transmissible spongiform encephalopathies and possibly permit identification
of other presently unrecognized variants.  Such an assay could also permit
study of the factors responsible for transmission of prion disease both within
and between species.

The assay should permit detection of abnormal isoforms of the prion protein or
of suitable surrogate markers.  The assay should also be capable of detecting
and distinguishing between sporadic and new variant CJD.  In addition the
assay should be validated as a measure of infectivity by the use of rodent 
and/or small primate animal models.  The assay should be reliable, rapid and
adaptable to clinicopathological laboratories in addition to research
laboratories.

Prospective offerors are expected to have personnel resources adequate to
conduct the proposed research with expertise in the following areas: prion
and/or surrogate marker research, infectious and/or neurodegenerative
disorders of nervous system, development and use of animal models of prion
disease, development and use of bioassays of blood and body fluids in the
diagnosis of infectious diseases, evaluation of biohazards associated with
prion and/or surrogate marker disease research and assay development. 
Prospective offerors are also expected to have access to facilities adequate
to conduct the research such as: facilities for use of live vertebrate
animals, and appropriate barrier containment facilities for working with
infectious agents.

It is anticipated that two (2) cost-reimbursement type contracts may be
awarded for a maximum period of up to five years. 

BAA/Request for Proposals (RFP) No. NIH-NINDS-99-11 will be AVAILABLE
ELECTRONICALLY and may be downloaded at URL
http://www.ninds.nih.gov/funding/funding_announcements/funding_opps.htm
on or about August 18, 1999.  This solicitation will be issued in electronic 
format only.  Proposals will bedue on or about January 16, 2000, or five months 
after issuance of thesolicitation. The exact proposal receipt date will be 
specified in thesolicitation.  OFFERORS ARE RESPONSIBLE FOR ROUTINELY CHECKING 
THIS WEBSITE FOR ANY POSSIBLE SOLICITATION AMENDMENTS THAT MAY BE ISSUED.  NO 
INDIVIDUAL NOTIFICATION OF ANY AMENDMENTS WILL BE PROVIDED.  All responsible 
sources may submit a proposal that will be considered by the agency.  This
advertisement does not commit the Government to award a contract.

INQUIRIES

Inquiries may be directed to:

Kirkland L. Davis, Contracting Officer
Contracts Management Branch
National Institute of Neurological Disorders and Stroke
Neuroscience Center, Room 3287
6001 Executive Boulevard, MSC 9531
Bethesda, MD  20892-9531
Tel:  (301) 496-1813
Fax:  (301) 402-4225
Email:  kd17c@nih.gov



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