Press Release
FDA Approves New Test to Aid in the Diagnosis of Rheumatoid Arthritis
October 20, 2009
Abbott Park, Illinois (NYSE: ABT)
— 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.
Media:
Darcy Ross |
(847) 937-3655 |
Financial:
Tina Ventura |
(847) 935-9390 |
