The PROCLEIX assays offered by Hologic 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 Hologic Gen-Probe, including target capture and Transcription-Mediated Amplification (TMA). Hologic Gen-Probe also manufactures the products, which are marketed worldwide by Novartis Diagnostics.

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. Hologic 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.

PROCLEIX WNV Assay (West Nile Virus)
The WNV assay detects the presence of West Nile Virus (WNV) in Blood Donations. 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. Hologic 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 Hologic 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.

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 world wide since 2006. In 2007, Hologic 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 ULTRIO Plus Assay
The PROCLEIX ULTRIO Plus Assay was designed to enhance the Ultrio assay by improving the sensitivity for Hepatitis B virus (HBV) in donated blood. It was CE marked in 2009, US clinical Trials are planned for 2010. It is also available on the fully automated PROCLEIX TIGRIS System.

PROCLEIX and ULTRIO are trademarks of Novartis Vaccines and diagnostics, Inc. ULTRIO PLUS is a trademark of Novartis AG.

PROCLEIX and ULTRIO are trademarks of Novartis Vaccines and diagnostics, Inc. ULTRIO PLUS is a trademark of Novartis AG.