Gen-Probe receives contract funding to initiate development of a sceening test for West nile virus

Gen-Probe Incorporated an established leader in molecular diagnostics based on its patented nucleic acid testing (NAT) technologies, today announced that it has received $1.0 million from the National Heart, Lung and Blood Institute (NHLBI) of the National Institutes of Health (NIH) to begin development of a nucleic acid screening test for the detection of West Nile virus (WNV).

These funds, which will be provided over a 12-month period, have been added to Gen-Probe's current contract, which was established in 1999 for the development of NAT assays for human immunodeficiency virus type 1 (HIV-1), hepatitis C virus (HCV) and hepatitis B virus (HBV). This award is one of a series that have been given to Gen-Probe since its first NIH contract in 1996 to help increase the safety of the nation's blood and organ donations.

As of October 2, 2002, the Centers for Disease Control and Prevention (CDC) reported 2,530 cases of WNV in the U.S. with 125 deaths. In a small number of cases, transmission is believed to have occurred by transplanted organs or blood transfusion. The NHLBI contract, entitled "Refinement of New Assays for Direct Detection of Nucleic Acids in Donated Organs" will fund the initial development of an assay to identify the presence of WNV in blood from organ donors. Due to the urgent need to develop such an assay, the proposed testing method is a single assay to detect WNV rather than a combination assay for multiple viruses.

The WNV assay will be developed using Gen-Probe's family of technologies, including a unique nucleic acid amplification technique called Transcription-Mediated Amplification (TMA). Researchers have demonstrated that TMA technology can improve the safety of the blood supply by directly detecting and amplifying viral nucleic acids in the test tube. This technology allows significantly earlier detection of infection than immunological tests, which require that antibodies or viral proteins reach detectable levels in the body.