A new diagnostictool, which studies show can aid in determining the risk of whether a pelvicmass is benign or malignant, is now available in Europe. This simple bloodtest is expected to help in the assessment of epithelial ovarian cancer, themost lethal form of gynecological cancer. This important immunoassay, whichwill run on Abbott’s ARCHITECT systems, is the first automated HE4 testavailable anywhere in the world. Research has shown that this novel diagnostic marker, combined with othertests such as the CA125 assay, can aid in measuring the risk of epithelialovarian cancer in pre- and post-menopausal women who have a pelvic mass.According to the International Agency for Research on Cancer, thefive-year survival rate of ovarian cancer patients is 46 percent. However,when the disease is diagnosed earlier, the survival rate increases to 94percent. “The ability of this test to help physicians predict whether a pelvic massis benign or malignant is an important development for both patients andphysicians,” said Michael Warmuth, senior vice president, diagnostics, Abbott.”Abbott’s ARCHITECT HE4 test will aid physicians in determining the mostappropriate treatment for their patients.” Abbott partnered with Fujirebio Diagnostics, Inc. in the development ofthe assay. The test is now available in several European countries, as well asin some countries in Asia Pacific and Latin America. The ARCHITECT HE4 Assaywas recently submitted to the FDA for 510(k) clearance.
