ARCHITECT HIV Ag/Ab Combo Test Wins Prestigious Chicago Innovation Award

Fifth Innovation Award for Abbott in Seven Years Recognizes Innovative Test for Earlier Detection of HIV

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Nov 03, 2010, 09:00 ET

ABBOTT PARK, Ill., Nov. 3, 2010 /PRNewswire/ -- Abbott today announced it has received a 2010 Chicago Innovation Award for its ARCHITECT HIV Ag/Ab Combo assay, the first test approved in the United States that can simultaneously detect both HIV antigens and antibodies.

The HIV Ag/Ab Combo test was approved by the U.S. Food and Drug Administration and launched in September 2010, allowing patients to be diagnosed earlier than ever before. Studies conducted by the Centers for Disease Control and Prevention (CDC) show that current antibody-only tests miss 10.5 percent of HIV infections in some high-risk populations because they do not detect antigens. However, Abbott's new assay detects the HIV p24 antigen, or the direct presence of HIV, allowing for diagnosis of early infections days before antibodies emerge, which is important in controlling the spread of the infection.

"Receiving the Chicago Innovation Award is a great testament to Abbott's constant pursuit of innovation, which is driven by the search for meaningful solutions – like the HIV Combo test – for the patients who rely on us," said Edward L. Michael, executive vice president, diagnostic products, Abbott.

This is the fifth Chicago Innovation Award that Abbott has received in seven years. Most recently, its XIENCE V™ Everolimus Eluting Coronary Stent System received the honor in 2008. In 2007, the Abbott m2000™ molecular diagnostic instrument in combination with the RealTime HIV-1 viral load test received the honor. In 2005, the company's PathVysion™ breast cancer test received the honor, and in 2003, HUMIRA®, a biologic treatment for certain immunological diseases, won the award. In addition, Abbott's Similac® SimplePac™ container won the Chicago Innovation Award's first-ever People's Choice Award in the 2009.

This is the latest recognition for Abbott's scientific innovation. Abbott's MitraClip® system, an investigational device used for catheter-based mitral valve repair, was recognized in The Wall Street Journal's 2010 Technology Innovation Awards. In 2009, Abbott's PLEX-ID was the overall Gold winner of The Wall Street Journal Technology Innovation Awards; it was also named one of the top scientific innovations by The Scientist magazine. Abbott also has earned recognition as one of the best places for scientists to work from The Scientist and Science magazines.

Sponsored by Kuczmarski and Associates and BusinessWeek, the Chicago Innovation Awards create awareness of the contributions of Chicago-area companies and organizations in developing innovative products and services that uniquely fill unmet needs and change lives. Abbott and other awardees were recognized at a ceremony and reception at the Goodman Theatre attended by approximately 800 local business, academic and government leaders.

Important Product Usage and Safety Information

The ARCHITECT HIV Ag/Ab Combo assay is a chemiluminescent microparticle immunoassay (CMIA) 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 human serum and plasma (EDTA and heparin). The ARCHITECT HIV Ag/Ab Combo 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. The assay may also be used as an aid in the diagnosis of HIV-1/HIV-2 infection in pediatric subjects (i.e., children as young as two years of age) and in pregnant women. An ARCHITECT HIV Ag/Ab Combo reactive result does not distinguish between the detection of HIV p24 antigen, HIV-1 antibody, or HIV-2 antibody.

The ARCHITECT HIV Ag/Ab Combo is not intended for use in screening blood or plasma donors. The effectiveness of ARCHITECT HIV Ag/Ab Combo for use in screening blood or plasma donors has not been established. However, this assay can be used as a blood donor screening assay in urgent situations where traditional licensed blood donor screening tests are unavailable or their use is impractical. The performance of this assay has not been established for individuals younger than two years of age. Definitive diagnosis of HIV infection in early infancy requires other assays. Assay results should be interpreted in conjunction with the patient's clinical presentation, history, and other laboratory results. If the results are inconsistent with clinical evidence, additional testing is suggested to confirm the result. This product requires the handling of human specimens. It is recommended that these reagents and human specimens be handled in accordance with the OSHA Standard on Bloodborne Pathogens. Assay specific information is presented in the assay package insert which can be accessed at www.abbottdiagnostics.com once the product is available.

About Abbott

Abbott (NYSE: ABT) is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs nearly 90,000 people and markets its products in more than 130 countries.

Abbott's news releases and other information are available on the company's Web site at www.abbott.com.

SOURCE Abbott