The PROCLEIX^® assays offered by Gen-Probe in collaboration with Novartis Vaccines and Diagnostics, Inc. have significantly increased the safety of the world’s supply of donated blood by directly detecting the genetic material of viruses such as HIV-1 and hepatitis C.  Our products and other screening techniques have reduced the risk of contracting these dangerous diseases from a blood transfusion in the US to approximately one in two million.  PROCLEIX assays employ innovative technologies developed by Gen-Probe, including target capture and Transcription-Mediated Amplification (TMA).  Gen-Probe also manufactures the products, which are marketed worldwide by Chiron, a Novartis business.

PROCLEIX^® HIV-1/HCV Assay

The PROCLEIX HIV-1/HCV Assay can simultaneously detect the presence of HIV-1 (Human Immunodeficiency Virus) and HCV (Hepatitis C Virus) in donated blood. Gen-Probe received approval of its Biologics License Application (BLA) for the PROCLEIX HIV-1/HCV Assay in 2002, making it the first FDA-approved nucleic acid test for screening donated human blood. In the United States, blood bank customers use PROCLEIX products to safeguard more than 80% of the blood units donated annually.  The assay is also approved and used regularly in more than 20 countries.

PROCLEIX^® ULTRIO^® Assay

The PROCLEIX ULTRIO Assay was designed to simultaneously detect HIV-1, HCV and the Hepatitis B virus (HBV) in donated blood.  It has been available outside the United States since early 2004, where blood bank customers have routinely intercepted HBV-infected donations that otherwise would have been transfused.

In the United States, the PROCLEIX ULTRIO Assay was approved in 2006 to screen donated blood for HIV-1 and HCV. Post-marketing studies are currently underway to develop the data necessary to obtain a blood screening claim for HBV.

In 2007, Gen-Probe gained FDA approval for the use of the PROCLEIX ULTRIO Assay on the high-throughput, fully automated PROCLEIX^® TIGRIS^® System.   This system offers customers a higher level of productivity that facilitates testing in smaller pool sizes, which in turn can increase testing sensitivity and blood safety.

PROCLEIX^® WNV Assay

West Nile virus (WNV) is a mosquito-borne virus that can cause mild, flu-like symptoms as well as severe neurological disease. The first confirmed U.S. death resulting from WNV transmission through donated blood was reported in 2002. In the fall of that year, the FDA challenged industry to develop a test for the direct detection of WNV in donated blood.  Gen-Probe met this challenge in June of 2003, and since then U.S. blood centers have used the PROCLEIX WNV assay to screen tens of millions of units of donated blood, intercepting more than 1,500 infected donations.  The PROCLEIX WNV Assay was approved for use on Gen-Probe’s semi-automated instrument system in 2005, and for use on the PROCLEIX TIGRIS System in 2006.  The fully automated, high-throughput PROCLEIX TIGRIS System can process 1,000 blood samples in about 14 hours.