The 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.
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.
Olle Nilsson, vice president and chief scientific officer of Fujirebio, said: “The new HE4 test is a major step in the fight against ovarian cancer worldwide. The same data used to support the CE mark certification has been submitted to the FDA and we hope to see availability of the test in the US during 2008.”