Contract Management Branch, National Institute of Neurological Disorders and Stroke, Neuroscience Center, Suite 3287, 6001 Executive Blvd., MSC 9531, Bethesda, Maryland 20892-9531

A -- DEVELOPMENT OF RAPID ASSAY FOR CREUTZFELDT-JAKOB DISEASE POC Kirkland L. Davis, Contracting Officer (301) 496-1813 WEB: Click here to download RFI notice., http://www.ninds.nih.gov/cmb. E-MAIL: E-mail Contracting Officer here., kd17c@nih.gov. The 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 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: 1. 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; 2. How an assay might be validated as a measure of infectivity; and 3. 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 kd17c@nih.gov, will also be accepted. Posted 05/06/99 (W-SN328371). (0126)

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