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27 SEPTEMBER, 2004

bioMérieux innovates further in the fight against AIDS

Marcy l'Etoile, France - September 27th, 2004. A major player in the field of in vitro diagnostics, bioMérieux confirms its constant commitment to the fight against AIDS with the launch of two new advanced 4th generation tests for HIV screening. VIDAS® HIV DUO ULTRA and VIDAS HIV DUO QUICK, developed for use on the automated VIDAS immunoanalysis system, are ultra-sensitive tests, providing even earlier detection of HIV infection.

The number of people living with HIV is still increasing every year. In 2003, a total of 37.8 million people were estimated to be living with HIV, and the number of deaths from AIDS was 2.9 million[1]. The number of adults and children newly infected with HIV reached 4.8 million in 2003, the equivalent of 13,000 new cases each day, or 9 new cases each minute.

The HIV virus is most easily transmitted to others during the initial period of acute HIV infection, when the viral load (quantity of HIV RNA in the blood) is especia lly high and when people are not aware of being contaminated by the virus. Most HIV infections are transmitted at this stage, called primary infection. Earlier detection using ultra-sensitive tests avoids missing primary infections, enabling immediate precautionary measures to be taken to help prevent the risk of HIV transmission to a non- infected partner, to an unborn child, or through blood donations or direct blood contact. Earlier detection of HIV infection also ensures the implementation of early antiretroviral therapy to slow down the progression of HIV infection, thereby improving patient care and quality of life.

“bioMérieux has made a new breakthrough in the race to fight AIDS by developing two advanced 4th generation HIV tests, which offer greater sensitivity required for earlier detection of HIV infection” declared Benoît Adelus, Executive Vice President of bioMérieux.

VIDAS® HIV DUO QUICK and VIDAS HIV DUO ULTRA are more sensitive than bioMérieux’s current 4th generation test. VIDAS HIV DUO QUICK also offers greater specificity (99.88% based on 5027 blood donor samples[2]), detection of all HIV types and subtypes tested, and a rapid result time (1 hour 20 minutes), making it ideal for routine laboratory testing.

More dedicated to expert laboratories, VIDAS HIV DUO ULTRA offers all the benefits of VIDAS HIV DUO QUICK with the addition of a real innovation in HIV testing. Indeed, VIDAS HIV DUO ULTRA can simultaneously provide dual information to laboratory professionals by recording separate signals for HIV antigen (Ag) and antibodies (Ab), whereas, until now, available tests provided only one combined signal. This enables laboratory professionals to make a more informed decision concerning the choice of confirmation test to be performed on the HIV sample.

“Offering both ultra-sensitivity and separate Ag/Ab signals, VIDAS HIV DUO ULTRA is set to become the future reference screening test for HIV infection” added Docteur Christophe Mérieux, Senior Corporate Vice President of bioMérieux, Research-Development & Medical Affairs.

bioMérieux in the field of HIV diagnostics
bioMérieux has almost 20 years of experience in HIV testing and offers a unique range of tests for early diagnosis and monitoring of HIV infection, which covers microplates, immunoassays and molecular biology techniques. Its first HIV screening tests were developed as of 1985 and form the Vironostika range of microplate assays for high- volume testing. In the 90s, bioMérieux developed a range on automated HIV tests on the VIDAS immunoana lyser (including VIDAS HIV p24 for the specific quantification of HIV antigen in blood samples) and brought its first 4th generation HIV test, VIDAS HIV DUO, onto the market in 1996. Moving into molecular biology technologies, bioMérieux recently developed the first real-time NASBA®[3] test, NucliSens EasyQ® HIV-1.1, for HIV-1 viral load measurement, used to monitor the efficacy of HIV treatments. In 2004, bioMérieux signed an agreement to support the Clinton Foundation HIV/AIDS initiative, showing its on-going commitment to fighting AIDS. The company is currently developing further systems and reagents for HIV testing.

[1] Source: UNAIDS
[2] Details contained in package insert
[3] NASBA: Nucleic Acid Sequenced Based Amplification, a proprietary bioMérieux technology