Blood test to detect ovarian cancer human epididymis protein 4 (He4) gets EU approval : Abbott

Human epididymis protein 4 (He4) test, a new dignostic tool to detect ovarian cancer by Abbott, has been granted European approval.

He4 is a simple blood test to help in the assessment of epithelial ovarian cancer, the most lethal form of gynecological cancer.

Human epididymis protein 4 (HE4) is a secreted glycoprotein that is overexpressed by serous and endometrioid ovarian carcinomas.

He4 can determine the risk of whether a pelvic mass is benign or malignant.

He4 immunoassay, which will run on Abbott’s ARCHITECT systems, is the first automated HE4 test available anywhere in the world.

Research has shown that He4 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 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, according to the International Agency for Research on Cancer.

“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.

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.

Abbott Diagnostics is a global leader in in vitro diagnostics and offers a broad range of innovative instrument systems and tests for hospitals, reference labs, blood banks, physician offices and clinics.

With more than 69,000 institutional customers in more than 100 countries, Abbott’s diagnostic products offer customers automation, convenience, cost effectiveness and flexibility. Abbott Diagnostics has developed certain first-of-a-kind products and significant technological advancements, including the development of the very first diagnostic test to detect HIV.

Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. Abbott employs more than 72,000 people and markets its products in more than 130 countries.