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FDA Clears Phadia US Inc.'s New Test To Diagnose Rheumatoid Arthritis In Early Stages


10/27/2006 10:02:33 AM

PORTAGE, Mich., Oct. 27 /PRNewswire/ -- Phadia US Inc. today announced that the United States Food and Drug Administration has cleared EliA(TM) CCP, the first and only fully automated assay for the measurement of cyclic citrullinated peptide (CCP) antibodies, a highly specific indicator for rheumatoid arthritis (RA) that is found in the blood. RA is an autoimmune disease that is characterized by chronic inflammation in the joints. Patients with RA have periodic flare-ups that can lead to irreversible joint destruction, if misdiagnosed or left untreated(i).

"The availability of this assay will offer healthcare providers a more accurate tool to diagnose this debilitating condition at an early stage in the disease compared with older testing methods," said Michael Land, president and general manager of Phadia US Inc. "Diagnosing rheumatoid arthritis early is critical to effectively treat the condition before it progresses and causes permanent joint damage."

The EliA CCP Assay utilizes a small sample of blood drawn from a patient. The sample is then sent to a lab and analyzed for CCP levels through a CLIA-moderate complexity test, which is available on the ImmunoCAP(R) 100 and 250, two fully automated systems for autoimmune and allergy testing. The EliA system requires calibration only once monthly, provides superior precision, and delivers consistent, reproducible results for increased efficiency.

"The FDA clearance of the EliA CCP Assay is important as it offers clinicians and laboratorians a new test with superior performance characteristics," said Land.

"Phadia's technology offers health care providers an economical and automated test with new levels of precision, sensitivity and specificity."

Historically, physicians have diagnosed RA through the use of older and less effective laboratory tests, clinical history and physical examination using the disease classification criteria developed by the American College of Rheumatology. However, criteria that are typically associated with this debilitating condition, including nodule development and bone erosion, are rarely recognized in the early stages of RA(ii).

The specificity of testing for CCP in RA patients is greater than 96 percent(iii, iv, v). Furthermore, a positive CCP measurement provides the greatest prognosis of eventual disease severity in a patient(vi). As a result, the EliA CCP Assay gives physicians the ability to identify RA very early in the course of the disease and initiate, if necessary, an aggressive course of treatment at an earlier stage of the disease when medication is most effective in significantly reducing disease progression and joint damage.

Phadia AB, headquartered in Uppsala, Sweden, is the world leader in in vitro IgE diagnostic research and product development. Its U.S. affiliate is in Portage, Michigan. Phadia's ImmunoCAP(R) specific IgE blood test is the first allergy test to be cleared by the FDA as a truly quantitative test for pinpointing allergens and allergy blood testing is now recognized by the National Institutes of Health for asthma patients. The clearance of the EliA CCP assay contributes to the company's position as a leader in the antibody diagnostic market. For more information, call Phadia Customer Service at 1-800-346-4364.

(i) Vallbracht I, Rieber J, Oppermann M, et al. Diagnostic and clinical value of anti-cyclic citrullinated peptide antibodies compared with rheumatoid factor isotypes in rheumatoid arthritis. Ann Rheum Dis. 2004; 63:1079-1084. (ii) Vallbracht I, Rieber J, Oppermann M, et al. Diagnostic and clinical value of anti-cyclic citrullinated peptide antibodies compared with rheumatoid factor isotypes in rheumatoid arthritis. Ann Rheum Dis. 2004; 63:1079-1084. (iii) Bizzaro N, Mazzanti G, Tonutti E, et al. Diagnostic accuracy of the anti-citrulline antibody assay for rheumatoid arthritis. Clin Chem. 2001; 47:1089-1093. Erratum in: Clin Chem. 2001;47:1748. (iv) Sauerland U, Becker H, Seidel M, et al. Clinical utility of the anti-CCP assay: experiences with 700 patients. Ann N Y Acad Sci. 2005; 1050:314-318. (v) Lee DM, Schur PH. Clinical utility of the anti-CCP assay in patients with rheumatic diseases. Ann Rheum Dis. 2003;62:870-874. (vi) Vallbracht I, Rieber J, Oppermann M, et al. Diagnostic and clinical value of anti-cyclic citrullinated peptide antibodies compared with rheumatoid factor isotypes in rheumatoid arthritis. Ann Rheum Dis. 2004; 63:1079-1084.

Phadia US Inc.

CONTACT: Nora Plunkett for Phadia US Inc., +1-312-642-0789 ext. 204


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