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Abbott Gets European Approval For New Ovarian Cancer Diagnostic Test

Abbott has received European approval for a new diagnostic tool, which studies show, can aid in determining the risk of whether a pelvic mass is benign or malignant. It is now available in Europe.

This blood test is expected to help in the assessment of epithelial ovarian cancer. This immunoassay, which will run on Abbott’s Architect systems, is the first automated HE4 test available in the world, claims the company.

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.

Michael Warmuth, senior vice president of diagnostics at Abbott, said: “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. Abbott’s Architect HE4 test will aid physicians in determining the most appropriate treatment for their patients.”

Abbott partnered with Fujirebio Diagnostics 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.