FDA Clears New Test to Diagnose Rheumatoid Arthritis in Early Stages

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FDA Clears New Test to Diagnose Rheumatoid Arthritis in Early Stages

PORTAGE, Mich., Oct. 27 /PRNewswire/ -- Phadia US Inc. today

announced that the United States Food and Drug Administration has

cleared EliA 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

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® 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® 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.

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