Regulatory Approval for New Ovarian Cancer Diagnostic 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, the most lethal form of gynecological cancer. This important immunoassay, which will run on Abbott Diagnostics ARCHITECT systems, is the first automated HE4 test.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.

According to the International Agency for Research on Cancer, the five-year survival rate of ovarian cancer patients is 46 percent. However, when the disease is diagnosed earlier, the survival rate increases to 94 percent. "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," said Brian Blaser, 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 and recently received FDA clearance in the United States.