Ortho Clinical Diagnostics Receives FDA Approval for First Anti-HIV 1+2 Test for Use on Random Access, Integrated Laboratory Testing System (AEGiS.org) - Ortho Clinical Diagnostics Receives FDA Approval for First Anti-HIV 1+2 Test for Use on Random Access, Integrated Laboratory Testing System - Results Available in Less Than 50 Minutes, Helping Laboratories Improve Staff Efficiency and Increase Productivity
PRNewswire - October 14, 2009

RARITAN, N.J., Oct. 14 /PRNewswire/ -- Ortho Clinical Diagnostics today announced U.S. Food and Drug Administration (FDA) approval of a diagnostic assay for the detection of antibodies to human immunodeficiency virus (HIV) types 1+2 (Anti-HIV 1+2) for use on the VITROS(R) 5600 Integrated and VITROS(R) 3600 Immunodiagnostic Systems. This is the first HIV diagnostic assay approved for an integrated system in the United States, allowing laboratories to run HIV and other routine tests on a single testing platform and eliminating the need for expensive batch testing of multiple patient samples.
"By providing a fast, cost-effective and reliable method for testing HIV, the VITROS(R) Anti-HIV 1+2 Assay will help enhance the clinical laboratory's ability to adhere to the Centers for Disease Control and Prevention (CDC) HIV screening guidelines, while at the same time increasing the lab's productivity and efficiency," said Mike Samoszuk, M.D., Chief Medical Officer, Ortho Clinical Diagnostics. "This approval underscores Ortho Clinical Diagnostics' continuing commitment to providing clinical laboratories with tests that help detect diseases earlier for better patient outcomes."
The CDC recommends routine screening for people between the ages of 13 and 64 during annual check-ups, pregnant women either before or during pregnancy, and newborns. Currently, more than 230,000 people living with HIV in the U.S. are unaware they have the disease, increasing the need for routine screening.(1) HIV screening plays an invaluable role in early disease detection, prevention and treatment.
The VITROS(R) Anti-HIV 1+2 Assay is an in vitro diagnostic immunoassay for the qualitative detection of HIV 1+2 in human serum and plasma. It provides physicians with a reliable and quick test for HIV, a virus that causes acquired immunodeficiency syndrome (AIDS) and can lead to death. It may also be used to screen for HIV in pregnant women 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(R) 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(R) 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(R) 5600 Integrated and VITROS(R) 3600 Immunodiagnostic Systems at the end of 2008, 112 assays have been released. Approval of the complete VITROS(R) 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(R) 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(R) 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(R) 5600 Integrated System
The VITROS(R) 5600 Integrated System is a high-capacity system that integrates clinical chemistry and immunoassay testing on one platform using innovative Sample Centered Processing. The VITROS(R) 5600 Platform is smaller than many other systems and does not have any water or drainage requirements, making the most of limited lab space while allowing flexibility in instrument location.
About the VITROS(R) 3600 Immunodiagnostic System
The VITROS(R) 3600 Immunodiagnostic System is a high-capacity immunoassay system with Intelligent Sample Management for routine and specialty testing. The VITROS(R) 3600 Immunodiagnostic System offers a broad menu of 47 immunoassays, covering disease states such as cardiology, oncology, endocrinology, infectious disease, thyroid, metabolic conditions and anemia.
About Ortho Clinical Diagnostics
Ortho-Clinical Diagnostics, Inc., a Johnson & Johnson company, delivers the high-quality in vitro diagnostic products that give healthcare professionals around the world the knowledge they need to make better treatment decisions sooner. The company serves the global transfusion medicine community with donor screening and blood typing products to help ensure every patient receives blood that is safe, the right type and the right unit. Ortho Clinical Diagnostics also brings sophisticated information management, testing technologies, and automation and interpretation tools to clinical laboratories worldwide to help them run more efficiently and improve patient care. For more information, visit www.orthoclinical.com .
(1) The National Institute of Allergy and Infectious Diseases, "HIV/AIDS Testing and Diagnosis." Available at: http://www3.niaid.nih.gov/topics/HIVAIDS/Understanding/diagnosis.htm. Accessed October 7, 2009.
(2) Centers for Disease Control and Prevention (CDC), "HIV Basic Facts." Available at: http://www.cdc.gov/hiv/topics/basic/index.htm#hiv . Accessed October 8, 2009.
(3) U.S. National Library of Medicine, "HIV Infection." Available at: http://www.nlm.nih.gov/medlineplus/ency/article/000602.htm . Accessed October 8, 2009.
(4) Centers for Disease Control and Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention. 2006 Disease Profile, 2008. Available at: http://www.cdc.gov/nchhstp/Publications/docs/2006_Disease_Profile508_FINAL.pdf 
Accessed October 7, 2009.
CONTACT: Media, Linda Davis, +1-908-218-8494, Cell: +1-215-272-8787; Investors, Louise Mehrotra, +1-732-524-6491, or Stan Panasewicz, +1-732-524-2524
091014 PR091008

Copyright ? 2009 - PRNewswire. All rights reserved. Reproduced with permission. Reproduction of this article (other than one copy for personal reference) must be cleared through PRNewswire, Permissions, 810 Seventh Ave., 32nd Floor, New York, NY 10019  http://www.prnewswire.com.
AEGiS is a 501(c)3, not-for-profit, tax-exempt, educational corporation. AEGiS is made possible through unrestricted funding from the Elton John AIDS Foundation, National Library of Medicine, AIDS Walk of Orange County, and donations from users like you.
AEGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.
Copyright ?1980, 2009. AEGiS. All materials appearing on AEGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of AEGiS, or the party credited as the provider of the content. [AEGiS]