FDA Approves New Test to Aid in the Diagnosis of Rheumatoid Arthritis

ABBOTT PARK, Ill., Oct. 20 /PRNewswire-FirstCall/ -- An important assay used
to aid in the diagnosis of rheumatoid arthritis (RA) will soon be available on
Abbott's ARCHITECT immunoassay analyzers. The FDA has granted 510(k)
clearance for an antibody cyclic-citrulinated peptide, or anti-CCP assay, to
run on the world class systems.

Many patients with RA develop an immune response against proteins containing
citrulline long before they present symptoms of the disease. Studies show
detecting the level of these antibodies earlier in the disease continuum, in
conjunction with other clinical information, is critical to the early
diagnosis of the disease. The American College of Rheumatology treatment
guidelines for RA recommends early diagnosis of the disease and timely
introduction of therapies to prevent potentially irreversible joint damage.

The assay was developed by Axis-Shield to run on Abbott's ARCHITECT i1000SR
and i2000SR systems. The anti-CCP assay is already approved and available on
the Abbott ARCHITECT outside the United States.

"The approval of the anti-CCP assay for use on the ARCHITECT provides an
important tool for physicians to aid in the early diagnosis of RA. We are
pleased to add this assay to the existing panel of autoimmune disease
biomarker assays currently available on the ARCHITECT and clinical chemistry
platforms as we underscore Abbott's continued commitment to the area of
immunology," said Michael Warmuth, senior vice president, diagnostics, Abbott.

Important Product Usage and Safety Information
The ARCHITECT Anti-CCP assay is a chemiluminescent microparticle immunoassay
(CMIA) for the semi-quantitative determination of the lgG class of
autoantibodies specific to cyclic citrullinated peptide (CCP) in human serum
or plasma on the ARCHITECT i System. Detection of anti-CCP antibodies is used
as an aid in the diagnosis of Rheumatoid Arthritis (RA) and should be used in
conjunction with other clinical information. This product is for in vitro
diagnostic use only. Use of this product requires the handling of human
specimens, and it is recommended that all human-sourced materials be
considered potentially infectious. This product contains sodium azide, and
both the material and its container should be disposed of safely. Assay
specific information is presented in the assay package insert which can be
accessed at www.abbottdiagnostics.com once the product is available.

About the ARCHITECT Instrument Family
The ARCHITECT family of analyzers includes the i1000SR and i2000SR for
immunoassay testing, the c4000, c8000, and c16000 for clinical chemistry
testing, and the ci4100, ci8200, and ci16200 integrated immunoassay/chemistry
systems. Abbott's unique technologies include the Robotic Sample Handler to
prioritize emergency tests; sample clot and bubble detection to verify
sampling integrity; and FlexRate and CHEMIFLEX assay technologies. ARCHITECT
systems use identical easy-to-use software and common reagents across all
members of the family.

About Abbott Diagnostics
Abbott Diagnostics is a global leader in in vitro diagnostics and offers a
broad range of innovative instrument systems and tests for hospitals,
reference labs, blood banks, physician offices and clinics. With more than
69,000 institutional customers in more than 100 countries, Abbott's diagnostic
products offer customers automation, convenience, cost effectiveness and
flexibility. Abbott has helped transform the practice of medical diagnostics
from an art to a science through the company's commitment to improving patient
care and lowering overall costs. The history of Abbott Diagnostics is filled
with examples of first-of-a-kind products and significant technological
advancements, including the development of the very first diagnostic test to
detect HIV.

About Abbott Immunology
Abbott is a leader in the discovery and development of innovative treatments
and diagnostics for immunologic diseases, including rheumatoid arthritis. The
ARCHITECT integrated platform provides RA testing including anti-CCP,
Rheumatoid Factor, and C-reactive protein (CRP). The Abbott Bioresearch
Center in Worcester, Massachusetts is the center of the company's efforts to
discover and develop new medicines for autoimmune diseases.

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.

SOURCE Abbott

Media, Darcy Ross, +1-847-937-3655, or Financial, Tina Ventura,
+1-847-935-9390, both of Abbott