Roche announced today 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 (2009) 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," said 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."
About the Test
The Elecsys HE4 assay is an immunoassay for the quantitative determination of HE4 in human serum and plasma. The assay is used as an aid in monitoring the recurrence or progressive disease in patients with epithelial ovarian cancer. Serial testing for patient HE4 assay values should be used in conjunction with other clinical findings used for monitoring ovarian cancer. The immunoassay is intended for use with Roche's electrochemiluminescence (ECL) technology, a highly sensitive light detection system that provides excellent low-end sensitivity and broad dynamic measuring ranges. The test is approved for use on the Elecsys 2010, cobas e 411, cobas e 601, cobas e602 and MODULAR ANALYTICS E170 analyzers.
About ovarian cancer
Ovarian cancer is the fourth most common cause of cancer-related death in women worldwide. It is the most lethal form of gynecological cancer, and potentially curable if diagnosed early and treated by surgeons familiar with the management of ovarian cancer. However, the symptoms of ovarian cancer are related to the presence of adnexal masses and are often vague and unspecific. Thus 70-75% of ovarian cancers are detected at a late stage. According to the International Agency for Research on Cancer, the 5 year survival rate of ovarian cancer patients is 46%. However, if the disease is diagnosed early, the survival rate increases up to 94%.