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Phadia's fully automated RA (rheumatoid arthritis) test:

This article was originally published in Clinica

Executive Summary

Phadia has received US FDA 510(k) clearance to sell what it claims is the first cyclic citrullinated peptide (CCP) antibodies-based test for rheumatoid arthritis (RA) that is fully automated. The EliA CCP assay enables physicians to identify RA very early in the course of the disease and begin, if necessary, an aggressive course of treatment at an earlier stage of the disease when medication is most effective, said the Uppsala, Sweden-based firm. It uses a small sample of blood, which is then analysed for CCP levels through a CLIA-moderate complexity test, which is available on the firm's ImmunoCAP 100 and 250 fully automated laboratory instruments. In its regulatory clearance, the FDA deemed EliA CCP to be substantially equivalent to Axis-Shield's Diastat Anti-CCP test.

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