European women facing "the silent killer" now have access to a breakthrough test to identify their risk of ovarian cancer.
Fujirebio Diagnostics, the industry leader in biomarker assays, announces that its HE4 test is now CE marked, a mandatory conformity mark on many products placed on the single market in the European Economic Area (EEA). Now available for sale throughout the European Union, the simple blood test measures for a substance known as HE4, which many studies have shown can be elevated in epithelial ovarian cancers. The test is intended to be used in conjunction with the CanAg CA 125 EIA or the Abbott ARCHITECT CA 125 II as an aid in estimating risk of epithelial ovarian cancer in women presenting with a pelvic mass prior to surgery.
For many years CA 125 has been the gold standard for monitoring ovarian cancer; however, this test is limited in its sensitivity and specificity as well as its ability to detect all types of ovarian cancer, prompting researchers to seek out additional indicators or “biomarkers” to complement CA 125 that offer higher sensitivity and can be indicative of the disease.
“The new HE4 test is a major step in the fight against ovarian cancer worldwide,” said Dr. Olle Nilsson, vice president and chief scientific officer of Fujirebio Diagnostics. “ The same data used to support the CE mark certification has been submitted to the U.S. Food and Drug Administration (FDA) and we hope to see availability of the test in the United States during 2008. ”
With the HE4 test, risk for epithelial ovarian cancer is determined by using a mathematical algorithm that combines the HE4 and CA 125 values. The test is also intended to be used as an aid in monitoring response to therapy for patients with invasive epithelial ovarian cancer.