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Oct 13, 2010

FDA Approves Axis-Shield and Bio-Rad’s Diagnostic for RA

FDA Approves Axis-Shield and Bio-Rad’s Diagnostic for RA

Anti-CCP assay is based on Bio-Rad's BioPlex 2200 system. []

  • Axis-Shield and Bio-Rad Laboratories received FDA clearance of the BioPlex® 2200 Anti-CCP test for the detection of rheumatoid arthritis (RA). The assay, which measures anticyclic citrullinated peptide antibodies (anti-CCP), has also been launched in the U.S.

    The companies say that the test can accurately diagnose RA in early synovitis patients, differentiate RA from other inflammatory arthritides and connective tissue diseases like lupus, and provide confirmation of diagnosis in seronegative RA.

    The test runs on Bio-Rad’s BioPlex 2200 platform and is based on Axis-Shield's anti-CCP technology. It has been available in certain territories outside the U.S. since earlier this year. “Test availability on this versatile analyzer represents the first time that anti-CCP has been offered on a multiplex autoimmune platform,” notes Ian Gilham, Axis-Shield's CEO. “We believe this will encourage market expansion as the autoimmune nature of many conditions becomes increasingly recognized.”

    John Goetz, Bio-Rad vp and group manager of clinical diagnostics, adds that the sanction allows the company to expand its “presence in the U.S. by offering a more compelling menu for infectious disease serology and autoimmune testing laboratories.” 

    The BioPlex 2200 system is a fully automated, random-access multiplex testing system and provides clinical laboratories with the capability to process multiple individual tests that are traditionally processed separately. The BioPlex 2200 system conserves patient sample volume, consolidates workstations, and simplifies workflow.

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