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Jan 14, 2010

Abbott Wins CE Mark for Epithelial Ovarian Cancer Diagnostic

  • Abbott’s blood test for the assessment of epithelial ovarian cancer has been approved in the EU. The diagnostic helps determine the risk of whether a pelvic mass is benign or malignant.

    The immunoassay will run on Abbott's Architect systems and is reportedly the first automated human epididymis protein 4 (HE4) test available. Research has shown that this diagnostic marker combined with other tests such as the CA125 assay can aid in measuring the risk of epithelial ovarian cancer in pre- and postmenopausal women who have a pelvic mass.

    Abbott partnered with Fujirebio Diagnostics on the development of this assay. The test is now available in several European countries as well as in some countries in Asia Pacific and Latin America. Additionally, the Architect HE4 Assay was recently submitted to the FDA for 510(k) clearance.

     



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