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Ortho Clinical Diagnostics Receives FDA Approval for First Anti-HIV 1+2 Test for Use on Random Access, Integrated Laboratory Testing System
Date:10/14/2009

to identify neonates who are at high risk of acquiring HIV during the perinatal period.(2) Being aware of a mother's HIV status enables physicians to prevent mother-to-child HIV transmission by providing antiretroviral treatment to both mothers and their babies.

Following the recent approval of the VITROS® Anti-HCV Assay for the qualitative detection of immunoglobulin G antibody to hepatitis C virus in human serum and plasma, the approval of the VITROS® Anti-HIV 1+2 Assay marks another important milestone in the launches of Ortho Clinical Diagnostics' clinical laboratory testing platforms. Since the launches of the VITROS® 5600 Integrated and VITROS® 3600 Immunodiagnostic Systems at the end of 2008, 112 assays have been released. Approval of the complete VITROS® Menu of 114 assays is expected by mid-2010.

Ortho Clinical Diagnostics' broad, world-class menu of immunoassays covers major disease states including cardiology, oncology, endocrinology, infectious disease, thyroid, metabolic conditions and anemia. The company's VITROS® assay menu covers up to 90 percent of the top 100 assays and 99 percent of laboratory test volume, with numerous other assays in development. Upon full menu approval, only Ortho Clinical Diagnostics' VITROS® 5600 Integrated System will offer a complete infectious disease testing menu in the U.S., including HIV and rubella, in addition to a comprehensive menu of routine assays that can be run on a single platform.

About HIV

Human immunodeficiency virus (HIV) is a retrovirus that affects the immune cells of infected people by destroying certain white blood cells, called T-cells, which the body relies on to fight infection.(2) When opportunistic infections develop(3) (e.g., tuberculosis) or when the immune system is suppressed below a specific level, HIV-infected people are considered to have AIDS.(4)

About the VITROS® 5600 Integrate
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SOURCE Ortho-Clinical Diagnostics, Inc.
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