announce the U.S. market availability of the Elecsys HE4 assay, an FDA approved test used in monitoring patients with ovarian cancer. The HE4 test is used as an aid in monitoring the recurrence or progressive disease in patients with epithelial ovarian cancer.
Studies like K Huhtinen et al show that HE4 shows a high specificity to ovarian cancer over that of CA 125 alone. Both HE4 and CA 125 together, rather than either of them alone, provides a more accurate tool for differential diagnosis of patients with ovarian cancer and ovarian endometriotic cysts from healthy subjects.
"As a leader in oncology, Roche is committed to providing reliable tests that will enable physicians to deliver the best possible care to their patients," says Randy Pritchard, vice president of marketing at Roche Diagnostics Corporation. "The addition of the Elecsys HE4 assay further strengthens our tumor biomarker menu and means healthcare providers now have another tool to give them greater confidence in monitoring patients with ovarian cancer."