Abbott (ticker: ABT, exchange: New York Stock Exchange (.N))
News Release -
Abbott's m2000(TM) Molecular Diagnostic Instrument and RealTime HIV-1 Test Win Chicago Innovation Award
Abbott Innovations Honored for Third Time in Five Years
ABBOTT PARK, Ill., Oct. 22 /PRNewswire-FirstCall/ -- Abbott (NYSE: ABT)
has received a 2007 Chicago Innovation Award for its m2000(TM) molecular
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
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
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
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
"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,
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)
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.
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
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.
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.
CONTACT: Don Braakman of Abbott, +1-847-937-0080
Web site: http://www.abbott.com