EliAâ„¢ CCP: New Diagnostic Test that Detects Rheumatoid Arthritis (RA) in Early Stages, Received USFDA Clearance

Filed in archive Diagnostics on October 29, 2006

EliAâ„¢CCP, a product of Phadia US Inc., is 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.

Characterized by chronic inflammation in the joints, RA is an autoimmune disease by which patients can experience periodic flare-ups that can lead to irreversible joint destruction, if misdiagnosed or left untreated (i).

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.

Now, EliAâ„¢ CCP has been cleared by the USFDA for marketing, providing healthcare providers with a more accurate tool in the diagnosis of RA at an early stage in the disease compared to older testing methods.

Find more details from the press release.

(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.