Ovarian malignancies are a leading cause of cancer death in women because they are usually detected in the late stages when the disease is incurable.
Encouraging new research presented by Abbott shows that a novel diagnostic marker, human epididymal protein 4 or HE4, combined with other tests, can be used to more effectively monitor for early-stage ovarian cancer (EOC), improving treatment options for many of the 22,000 women in the United States who develop this deadly disease each year.
New research on HE4 presented today by Richard Moore, MD, associate professor in the Program for Women’s Oncology at Women and Infants’ Hospital/Brown University, at a scientific workshop hosted by Abbott, provides important validation for the use of the HE4 test in combination with CA125, the current standard for monitoring ovarian cancer, in estimating EOC risk in women presenting with pelvic masses. The HE4 test was developed through research efforts aimed at identifying combinations of biomarkers to add sensitivity to the CA125 test, which is limited in its sensitivity and specificity, as well as its ability to monitor early stage epithelial ovarian cancer (EOC).
"Our results show that the dual marker combination of HE4 and CA125 can aid in the differentiation of benign pelvic masses from ovarian malignancies in women diagnosed with a pelvic mass," said Moore. "This is exciting as it will help us improve the care we give to the many women who are afflicted by this deadly disease."
"More than 250,000 women present to their physician each year with a suspicious pelvic mass, yet there is still no reliable tool to differentiate malignant disease from other benign gynecologic conditions, making early detection a significant challenge," said Robert Doss, Ph.D., divisional vice president, research and development, Abbott Diagnostics. "HE4 represents an important advancement in monitoring these pelvic masses."
Fujirebio Diagnostics, Inc. and Abbott have signed a license agreement to develop this new ovarian cancer marker for use on Abbott’s automated ARCHITECT® diagnostic analyzers. A manual form of the HE4 test has been approved by the Food and Drug Association (FDA) as an aid in monitoring recurrence or progressive disease in patients with EOC and is CE marked for use within the European Union as an aid in estimating the risk of epithelial ovarian cancer in premenopausal and postmenopausal women.