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Abbott Laboratories’ HE4 Diagnostic Marker Test Shows Promise In Monitoring Ovarian Cancer

Abbott presented a new research at the American Association for Clinical Chemistry annual meeting. It shows that the human epididymal protein 4 or HE4 diagnostic marker combined with other tests can be used to more effectively monitor for early-stage ovarian cancer (EOC).

Abbott hosted a scientific workshop and Richard Moore, M.D., associate professor in the Program for Women’s Oncology at Women and Infants’ Hospital/Brown University presented a new research on HE4 which provides important validation for the use of the HE4 test in combination with CA125 in estimating EOC risk in women presenting with pelvic masses. The development of HE4 test was a research efforts aimed at identifying combinations of biomarkers to add sensitivity to the CA125 test as CA125 test was limited in its specificity and sensitivity, as well as its ability to monitor early stage epithelial ovarian cancer.

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.

Abbott and Fujirebio Diagnostics, Inc have signed a license agreement to develop this new ovarian cancer marker which will be used on Abbott’s automated ARCHITECT diagnostic analyzers. A manual form of the HE4 test is FDA approved as an aid in monitoring recurrence or progressive disease in patients with EOC and is also CE marked for use as an aid in estimating the risk of epithelial ovarian cancer in premenopausal and postmenopausal women.