Abbott submits Premarket Approval application for the ARCHITECT HIV Ag/Ab Combo assay to FDA

An assay to aid in the early detection of HIV infection may soon be available in the United States.  Abbott (NYSE: ABT) 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.