NIH, National Heart, Lung, & Blood Institute, BDR Contracts Section, Contracts Operations Branch, Rockledge Building (RKL2), Room 6135, 6701 ROCKLEDGE DR MSC 7902, BETHESDA MD 20892-7902

A -- REFINEMENT OF NEW ASSAYS FOR DIRECT DETECTION OF VIRAL NUCLEIC AC IDS IN DONATED BLOOD SOL NHLBI-HB-95-08 POC Lynda A. Bindseil, Contracting Officer, (301) 435-0355. The major objectives of this program are: 1) to refine for use in clinical laboratories, blood bank laboratories or both, one or more nucleic-acid based techniques that will be feasible for the direct detection of blood-borne viruses in donors of blood for transfusion to reduce the antibody-negative window period between infectivity and detection to the shortest possible time and, when possible, obviate the need for indirect antibody tests, and 2) to file for investigational new drug exemptions (INDs) with the Food and Drug Administration (FDA), and submit and obtain approval for product license applications (PLAs). The major focus for this research is the earliest detection of infection by HIV. Currently, the enzyme immunoassays employed by blood banks for the detection of HIV antibodies are required to detect the presence of HIV-1 and HIV-2 antibodies, these tests have been shown to detect many but not all antibodies to HIV-0. Hence, another important goal of this procurement is to obtain a nucleic acid-based assay capable of detecting HIV-1, HIV-2 and HIV-0. The assay should also have the flexibility to be readily adaptable to the detection of variants of HIV that may be described in the future. In addition, because of its clinical importance, HCV must also be detected in a similar system. To improve practicability, the detection of more than one agent per test (multiplex system) is an important goal. The two highest priority viruses to be detected, HIV and HCV, may or may not lend themselves to multiplexing together. The testing method(s) envisioned must be able to detect each of these viruses, alone or in multiplexing format, but earlier availability of an individual test is more important than a later availability of multiplexed tests. Tests for other blood-borne viruses (e.g., HTLV-I or II) are beyond the scope of this project, but may legitimately be part of multiplexing plans for the future. Presently available information indicates that the first detectable evidence for infection with HIV is a burst ofRNA virus in circulating plasma about 7-10 days after the infecting episode. Hence, this solicitation requires a test to detect this RNA virus burst. Nevertheless, in the replicative cycle of HIV, infectious RNA virus is first transcribed into DNA provirus which in turn is followed by an RNA viremia. A test to detect the provirus might be positive earlier than one that detects the RNA burst. Such a DNA test would be acceptable, provided sufficient data are included to support its value in shortening the window period to the maximum extent possible (equivalent to or shorter than a test for HIV RNA). The preclinical phase for a blood donor screening assay shall be completed within 18 months from contract award. The clinical phase/test validation shall be conducted at approved clinical trial sites and must be completed and the results submitted to the Center for Biologics Evaluation and Research (CBER) within a period of 14 months from receipt of the IND. An additional 4 months will allow for review of data by CBER officials and, ultimately, licensure of the procedure. It is anticipated that one (1) award will be made from this solicitation and that the award will be made on or about June 1, 1996. It is anticipated that the award will be a multiple-year cost reimbursement completion contract with a term of three (3) years. RFP NHLBI-95-08 will be released on or about September 22, 1995. To expedite requests for solicitation, please furnish three (3) self-addressed labels with your request. (0249)

Loren Data Corp. http://www.ld.com (SYN# 0002 19950907\A-0002.SOL)