Healthcare Industry News:  Axis-Shield 

Diagnostics FDA

 News Release - October 20, 2009

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

ABBOTT PARK, Ill., Oct. 20 (Healthcare Sales & Marketing Network) -- 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 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

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