Press Release
Abbott Submits New HIV Test to FDA for Expedited Review
January 25, 2010
Abbott Park, Illinois, (NYSE: ABT)
— 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.
ARCHITECTHIV Ag/Ab Combo assay is not intended for use in screening
blood, plasma or tissue donors. The effectiveness of ARCHITECTHIV 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.
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 more than
72,000 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.
ARCHITECT is a trademark of Abbott Laboratories.
Media:
Darcy Ross |
(847) 937-3655 |
Financial:
Tina Ventura |
(847) 935-9390 |
