Abbott Receives European Regulatory Approval for New Ovarian Cancer Diagnostic Test
Abbott announces CE Mark (Conformite Europeene) certification for the ARCHITECT human epididymis protein 4 (HE4) test
A new diagnostic tool, which studies show can aid in determining the risk of whether a pelvic mass is benign or malignant, is now available in Europe. This simple blood test is expected to help in the assessment of epithelial ovarian cancer. This immunoassay is the first automated HE4 test available anywhere in the world.
Research has shown that this novel diagnostic marker, combined with other tests such as the CA125 assay, can aid in measuring the risk of epithelial ovarian cancer in pre- and post-menopausal women who have a pelvic mass.
"The ability of this test to help physicians predict whether a pelvic mass is benign or malignant is an important development for both patients and physicians," saidMichael Warmuth, senior vice president, diagnostics, Abbott. "Abbott's ARCHITECT HE4 test will aid physicians in determining the most appropriate treatment for their patients."
Abbott partnered with Fujirebio Diagnostics, Inc. in the development of the assay. The test is now available in several European countries, as well as in some countries in Asia Pacific and Latin America.
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