FDA Approves First-of-Its-Kind HIV Test Which Can Detect HIV Days Earlier Than Current U.S. Tests

Abbott Park, Illinois (NYSE: ABT) — Every nine and a half minutes, someone in the United States is infected with HIV, and one out of every five of these individuals doesn’t know it. To help stem the spread of this disease, the U.S. Food and Drug Administration (FDA) today approved an innovative new diagnostic tool, which will allow patients to be diagnosed earlier than ever before.

Abbott’s ARCHITECT HIV Ag/Ab Combo assay is the first test approved in the United States that can simultaneously detect both HIV antigen and antibodies. HIV antigen is a protein produced by the virus immediately after infection, whereas antibodies are developed days later as the body works to fight off the infection. Studies have demonstrated that Abbott’s new test may detect HIV days earlier than antibody-only tests, which is important in controlling the spread of the virus.

“Since individuals are most infectious to others shortly after infection, detecting HIV earlier is critical and life saving,” said Peter Leone, M.D., medical director, North Carolina HIV/STD Prevention and Control Branch, University of North Carolina, Chapel Hill. “A significant percentage of new HIV infections are transmitted by someone with an undetected acute infection, so identifying more people earlier offers a significant opportunity for counseling, which can reduce high-risk behaviors and also initiate antiretroviral treatment for early-stage infection, if appropriate.”

Studies conducted by the Centers for Disease Control and Prevention (CDC) show that current antibody-only tests miss up to 10 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.

“Abbott has long been a pioneer in HIV testing -- from the world’s first test to detect HIV antibodies in 1985 -- to second and third generation immunoassay and molecular tests – and now the development of the country’s first antigen and antibody combination test,” said Brian Blaser, senior vice president, Diagnostics, Abbott.

“Abbott is committed to fighting HIV and to bringing novel tests to physicians in order to help patients get the care they need as soon as possible.”

This new test will run on Abbott’s ARCHITECT family of diagnostic testing instruments. It is already approved for use outside the United States. In Europe, HIV antigen-antibody combination testing is routine in public health settings and HIV testing guidelines in the United Kingdom now direct clinicians to use the HIV combination test as the first-line test.
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 adult and pediatric 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 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 HIV

The CDC estimates that there are 56,000 new cases of HIV in the United States annually, and that every nine and a half minutes, someone in the country is infected with HIV. UNAIDS estimates that 2.7 million people throughout the world are newly infected with HIV each year. Leading risk factors for HIV infection include high-risk heterosexual contact, intravenous drug use, and male-to-male sexual contact.
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.
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 approximately 83,000 people and markets its products in more than 130 countries.