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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