European approval for Abbott's new ovarian cancer diagnostic test

Jan 14 2010

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's ARCHITECT systems, 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.

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 Michael 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. The ARCHITECT HE4 Assay was recently submitted to the FDA for 510(k) clearance.

About Ovarian Cancer

Ovarian cancer is the leading cause of death from gynecological cancers and the fifth-leading cause of cancer death in women. An estimated one in 72 women will develop ovarian cancer in her lifetime. It accounts for 31 percent of cancers of the female genital organs. Women who are postmenopausal are at the greatest risk for ovarian cancer.