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2025'01.23.Thu
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2007'10.31.Wed
Abbott's m2000(TM) Molecular Diagnostic Instrument and RealTime HIV-1 Test Win Chicago Innovation Award
October 22, 2007


Abbott Innovations Honored for Third Time in Five Years


    ABBOTT PARK, Ill., Oct. 22
/Xinhua-PRNewswire-FirstCall/ -- 

    Abbott (NYSE: ABT) has received a 2007 Chicago
Innovation Award for its m2000(TM) molecular diagnostic
instrument (
http://www.abbott.com/global/url/content/en_US/60.15:15/feature/Feature_0021.htm
) and the Abbott RealTime HIV-1 viral load test, the most
sensitive test of its kind capable of detecting and
precisely measuring all known strains of the human
immunodeficiency virus (HIV). 

    Abbott's RealTime HIV-1 test, approved for use in the
United States in May 2007, and run on the m2000 system, is
the only viral load test of its kind that can detect and
measure all group M, group N and group O strains of HIV-1
as well as non-B subtypes of the virus.  The products offer
physicians a quick and highly accurate test method to help
ensure their patients receive the most effective
treatment.

    This is the third time in five years Abbott has been
selected for a Chicago Innovation Award.  In 2005, the
company's PathVysion(TM) (http://www.pathvysion.com )
breast cancer test received the honor, and in 2003,
HUMIRA(TM)(http://humira.com ), the first human monoclonal
antibody drug for rheumatoid arthritis, won the award.

    "At Abbott we're in the business of improving
lives -- often saving lives.  That's an important
motivation in fostering innovation," said Miles D.
White, chairman and chief executive officer, Abbott. 
"Patients depend on us for new and better medicines,
diagnostics and nutritionals, and that inspires our
scientists everyday.  The m2000 and HIV-1 viral load test,
PathVysion and HUMIRA are just a few examples of the
caliber of research being conducted at Abbott to find
solutions to unmet medical needs."

    Sponsored by Kuczmarski and Associates and the Chicago
Sun-Times, the Chicago Innovation Awards are intended to
create awareness of the contributions of Chicago-area
companies in developing innovative products that change the
world.  Abbott and other awardees will be recognized at a
ceremony and reception tonight at the Goodman Theatre
attended by some 400 local business, academic and
government leaders.

    About the Abbott RealTime HIV-1 test and the m2000
instrument

    Since the first diagnostic tests for the HIV virus came
on the market in 1985, public health authorities have been
concerned about the virus' ability to mutate and create new
strains of subtypes that may elude detection.  Optimal
treatment of HIV depends on accurate measurement of viral
levels, but if variant subtypes are present and undetected,
drug therapy could be ineffective. 
 
    While many of the variant strains of the virus are not
as prevalent in the United States as other countries, new
studies suggest that that the influx of immigrants from
areas of the world where these strains are more common is
increasing the number of newly diagnosed patients infected
with variant HIV. 

    "With more than 20 years of experience in HIV
testing, our scientists identified a particular region of
the HIV genome resistant to the impact of mutations, and
were able to develop the first and only viral load assay of
its kind capable of detecting and measuring all known
strains of HIV," said John Robinson, Ph.D., senior
director, Research and Development, Abbott Molecular.  

    The RealTime HIV-1 assay is intended to monitor disease
prognosis and for use as an aid in assessing viral response
to antiretroviral drug treatments.  

    Quantitative measurements of HIV-1 levels in blood have
greatly contributed to the understanding of the process by
which the virus infection leads to disease and have been
shown to be an essential parameter in prognosis and
management of HIV infected individuals.  Decisions
regarding initiation or changes in antiretroviral therapy
are guided by monitoring plasma HIV-1 levels or viral load,
CD4-T cell count and the patient's clinical condition.  The
goal of antiretroviral therapy is to reduce the virus in
plasma to below detectable levels. 

    The RealTime HIV-1 test is intended for use in
conjunction with clinical presentation and other laboratory
markers as an indicator of disease prognosis and for use as
an aid in assessing viral response to antiretroviral
treatment as measured by changes in plasma HIV-1 RNA
levels.  The assay is not intended to be used as a
donor-screening test for HIV-1 or as a diagnostic test to
confirm the presence of HIV-1 infection.

    The RealTime HIV-1 test runs on the new Abbott m2000,
an automated system that uses real-time polymerase chain
reaction (PCR) to amplify, detect and measure minute levels
of virus in blood samples as well as extremely high levels
of these infectious agents.  Real-time PCR enables the
production of large quantities of DNA from very small
samples in a short period of time, making it possible to
detect extremely low levels of a virus's genetic material.


    "The m2000 instrument in combination with the
HIV-1 assay and Abbott-developed software gives clinical
laboratories the ability to automatically and quickly
measure very small levels of virus in patient samples,
allowing labs to deliver highly accurate test results in a
matter of hours," said Scott Safar, senior director,
Systems Development and Support, Abbott Molecular. 

    About PathVysion

    PathVysion is a test for breast cancer patients that
provides physicians with genetic information to help them
predict if a particular type of cancer treatment may be
effective for an individual patient.  PathVysion
fluorescence in situ hybridization (FISH) technology
measures the number of copies of the HER-2 gene at the DNA
level.  Using fluorescent colors and a microscope,
physicians count the actual number of HER-2 genes present
in the cell nucleus.  Results from the PathVysion kit are
intended for use as an aid in selecting potential
candidates for Herceptin(R) (trastuzumab) monoclonal
therapy and as an adjunct to existing clinical and
pathologic information currently used as prognostic factors
in stage II, node-positive breast cancer patients.  The
PathVysion kit is further indicated as an aid to predict
disease-free and overall survival in patients with stage
II, node-positive breast cancer treated with adjuvant
cyclophosphamide, doxorubicin and 5-fluorouracil (CAF)
chemotherapy.

    About Abbott's Molecular Diagnostics Business

    Abbott Molecular, a division of Abbott based in Des
Plaines, Ill., is an emerging leader in molecular
diagnostics -- the analysis of DNA, RNA and proteins at the
molecular level.  Abbott Molecular's instruments and tests
provide physicians with critical information based on the
early detection of pathogens and subtle, but key changes in
patients' genes and chromosomes.  The products help
physicians diagnose disease and infections earlier, select
appropriate therapies and monitor disease progression.  In
addition to the RealTime HIV-1 viral load test and the
Abbott m2000, Abbott Molecular's portfolio of products also
includes innovative genomic tests for chromosome changes
associated with congenital disorders and cancer.

    About HUMIRA

    In the United States, HUMIRA is approved by the Food
and Drug Administration (FDA) for reducing signs and
symptoms, inducing major clinical response, inhibiting the
progression of structural damage and improving physical
function in adult patients with moderately to severely
active rheumatoid arthritis. 
 
    HUMIRA is indicated for reducing the signs and symptoms
of active arthritis, inhibiting the progression of
structural damage and improving physical function in
patients with psoriatic arthritis.  HUMIRA can be used
alone or in combination with methotrexate or other
disease-modifying anti-rheumatic drugs (DMARDs).  

    HUMIRA is also approved for reducing signs and symptoms
in patients with active ankylosing spondylitis. 

    Earlier this year, HUMIRA was approved for reducing the
signs and symptoms and inducing and maintaining clinical
remission in adults with moderately to severely active
Crohn's disease who have had an inadequate response to
conventional therapy, and reducing the signs and symptoms
and inducing clinical remission in these patients if they
have also lost response to or are intolerant to
infliximab.

    Clinical trials are currently under way evaluating the
potential of HUMIRA in other immune-mediated diseases.

    Important Safety Information 

    Serious infections, sepsis, tuberculosis (TB) and
opportunistic infections, including fatalities, have been
reported with the use of TNF-blocking agents, including
HUMIRA.  Many of these serious infections have occurred in
patients also taking other immunosuppressive agents that in
addition to their underlying disease could predispose them
to infections.  Infections have also been reported in
patients receiving HUMIRA alone.  Treatment with HUMIRA
should not be initiated in patients with active infections.
 TNF-blocking agents, including HUMIRA, have been associated
with reactivation of hepatitis B (HBV) in patients who are
chronic carriers of this virus.  Some cases have been
fatal.  Patients at risk for HBV infection should be
evaluated for prior evidence of HBV infection before
initiating Humira.  The combination of HUMIRA and anakinra
is not recommended and patients using HUMIRA should not
receive live vaccines.

    More cases of malignancies have been observed among
patients receiving TNF blockers, including HUMIRA, compared
to control patients in clinical trials.  These malignancies,
other than lymphoma and non-melanoma skin cancer, were
similar in type and number to what would be expected in the
general population.  There was an approximately 3.5 fold
higher rate of lymphoma in combined controlled and
uncontrolled open label portions of HUMIRA clinical trials.
 The potential role of TNF-blocking therapy in the
development of malignancies is not known.  TNF-blocking
agents, including HUMIRA, have been associated in rare
cases with demyelinating disease and severe allergic
reactions.  Infrequent reports of serious blood disorders
have been reported with TNF-blocking agents. 

    Worsening congestive heart failure (CHF) has been
observed with TNF-blocking agents, including HUMIRA, and
new onset CHF has been reported with TNF-blocking agents. 
Treatment with HUMIRA may result in the formation of
autoantibodies and rarely, in development of a lupus-like
syndrome.

    The most frequent adverse events seen in the
placebo-controlled clinical trials in rheumatoid arthritis
(HUMIRA vs. placebo) were injection site reactions (20
percent vs. 14 percent), upper respiratory infection (17
percent vs. 13 percent), injection site pain (12 percent
vs. 12 percent), headache (12 percent vs. 8 percent), rash
(12 percent vs. 6 percent) and sinusitis (11 percent vs. 9
percent). Discontinuations due to adverse events were 7
percent for HUMIRA and 4 percent for placebo.  As with any
treatment program, the benefits and risks of HUMIRA should
be carefully considered before initiating therapy.

    In HUMIRA clinical trials for ankylosing spondylitis,
psoriatic arthritis and Crohn's disease, the safety profile
for patients treated with HUMIRA was similar to the safety
profile seen in patients with rheumatoid arthritis.

    About Abbott 

    Abbott 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 65,000 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
http://www.abbott.com .


    For more information, please contact:

     Don Braakman 
     Abbott
     Tel: +1-847-937-0080
PR
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