Abbott Submits New HIV Test To FDA For Expedited Review

Main Category: HIV / AIDS
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 26 Jan 2010 - 4:00 PDT

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An assay to aid in the early detection of HIV infection may soon be available in the United States. Abbott announced today it has submitted a Premarket Approval application for the ARCHITECT HIV Ag/Ab Combo assay to the U.S. Food and Drug Administration (FDA) for expedited review. Upon approval, the assay is expected to be the first test available in the United States to simultaneously detect the combined presence of HIV antigens (proteins produced by the HIV virus) and antibodies (proteins produced by the body to fight HIV antigens), which would allow for the early detection and ongoing monitoring of the virus.

Studies conducted by researchers in the United States, including the Centers for Disease Control and Prevention (CDC), show that antibody-only tests fail to identify up to 10 percent of HIV infections in some high-incidence populations. However, the detection of the HIV p24 antigen enables laboratories to diagnose HIV infection before HIV antibodies are able to be detected. A combined antibody and antigen test holds considerable promise for HIV screening and could assist in detecting infections before antibodies can be identified.

"The potential to diagnose HIV in the acute phase of the disease when antibodies are not yet present would be an important development in the fight against HIV," said Michael Warmuth, senior vice president, diagnostics, Abbott. "The earlier a patient can be diagnosed, the sooner the patient can be placed into care and the better chance there is to stop further spread of the virus."

The Abbott-developed ARCHITECT assay was approved for use in Europe in 2004, and is currently an investigational device in the United States. The U.S. submission comes as Abbott marks the 25th year since the company developed the first FDA approved test for HIV. This latest submission underscores Abbott's continued commitment and leadership in HIV diagnostics.

About ARCHITECT Ag/Ab HIV Combo Assay

The ARCHITECT HIV Ag/Ab Combo assay is designed for the simultaneous qualitative detection of human immunodeficiency virus (HIV) p24 antigen and antibodies to HIV type 1 (HIV 1 group M and group O) and/or type 2 (HIV-2) in adult and pediatric serum and plasma. The assay is intended to be used as an aid in the diagnosis of HIV-1/HIV-2 infection, including acute or primary HIV-1 infection. It is also intended to be used as an aid in the diagnosis of HIV-1/HIV-2 infection in pregnant women.

ARCHITECT HIV Ag/Ab Combo assay is not intended for use in screening blood, plasma or tissue donors. The effectiveness of ARCHITECT HIV Combo (Ag/Ab) for use in screening blood, plasma or tissue donors has not been established. The assay result does not distinguish between the detection of HIV p24 antigen, HIV-1 antibody, or HIV-2 antibody.

About HIV

The CDC estimates that there are 56,000 new cases of HIV in the United States annually. In 2008, UNAIDS estimated that 2.7 million people throughout the world are newly infected with HIV each year. Leading risk factors for HIV infection include male-to-male sexual contact, high-risk heterosexual contact and intravenous drug use.

Abbott and HIV

Abbott has been a leader in HIV/AIDS research since the early years of the epidemic. In 1985, the company developed the first licensed test to detect HIV antibodies in the blood and has marketed more than 20 HIV tests on six testing platforms to meet the unique customer needs in the United States and internationally. Abbott has developed two protease inhibitors for the treatment of HIV.

About Abbott's Diagnostics Businesses

Abbott is a global leader in in vitro diagnostics and offers a broad range of innovative instrument systems and tests for hospitals, reference labs, molecular labs, blood banks, physician offices and clinics. With more than 69,000 customers in more than 100 countries, Abbott's diagnostic products offer customers automation, convenience, bedside testing, cost effectiveness and flexibility. Abbott has helped transform the practice of medical diagnosis from an art to a science through the company's commitment to improving patient care and lowering costs.

Source
Abbott

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