Roche announced this week 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.
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 e 602 and MODULAR ANALYTICS E170 analyzers.
For more information: www.roche.com