FDA Approves New Diagnostic Test for RA

Christine Miller Health Guide
  • Last week, Phadia US Inc. announced that the U.S. Food and Drug Administration had cleared EliA (TM) CCP, the first fully automated assay for measuring cyclic citrullinated peptide (CCP) antibodies. CCP is an indicator for rheumatoid arthritis (RA) that is found in the blood. Phadia believes that this test will allow physicians to diagnose RA earlier and begin treatment more aggressively in order to stop disease progression and joint damage.

    Phadia has stated in press releases and news articles that this test provides a more accurate tool for diagnosing RA in its early stages compared with older testing methods. First, a small blood sample is drawn from a patient. The sample is then sent to a lab and analyzed for CCP levels through a CLIA-moderate complexity test. The test is used with automated systems for autoimmune and allergy testing. Phadia asserts that the automated assay with be economical for labs and healthcare providers with “new levels of precision, sensitivity and specificity."
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    Physicians have traditionally diagnosed RA through other laboratory tests, clinical history and physical examination using the disease classification criteria developed by the American College of Rheumatology. However, many symptoms or criteria that doctors look for in diagnosing RA (such as joint damage from bone erosion) are rarely seen in the early stages of RA. According to several studies, the specificity of testing for CCP in RA patients is greater than 96 percent. Research also shows that a positive CCP measurement may provide the greatest prognosis of eventual disease severity in a patient.

    Phadia AB, is based in Sweden, and specializes in in vitro IgE diagnostic research (antibody diagnostics) and product development. Its U.S. affiliate is in Portage, Michigan.

    Learn more about treatments for RA.
Published On: November 03, 2006