The FDA ( Food and Drug Administration ) has granted 510(k) clearance for marketing and use of a combination of blood tests for proteins HE4 and CA125 with the Risk of Ovarian Malignancy Algorithm ( ROMA ). Research demonstrates that examining levels of HE4 and CA125 using the ROMA algorithm shows the highest accuracy in determining ovarian cancer risk in pre- and post-menopausal women.
The combination of blood tests and the ROMA algorithm were developed through the research of a team led by Richard G. Moore, with the Program in Women's Oncology at Women & Infants Hospital of Rhode Island ( United States ).
The CA125 test has been the gold standard for monitoring patients diagnosed with ovarian cancer. The test, however, is limited in its sensitivity and specificity as well as its ability to detect all types of ovarian cancer. HE4 has been shown to be elevated in epithelial ovarian cancers, the most common type of ovarian cancer, but not elevated in many benign gynecologic diseases.
Combining physician assessment with the independently validated ROMA algorithm more accurately stratifies benign disease from ovarian cancer in women who present with a pelvic mass. It also enables physicians to identify those patients at high likelihood of malignancy who should have their surgery performed by a gynecologic oncologist.
Ovarian cancer is called a silent killer because it is difficult to diagnose with symptoms that are easily confused with other non-cancerous conditions. Three quarters of ovarian cancer cases are diagnosed at an advanced state, when the disease is more difficult to treat. Of patients who are diagnosed early ( stage I-II ), more than 90% will live past five years. However, only one quarter of cases are diagnosed in the early stages.
Clearance of ROMA as a risk-stratification tool is based on results of a prospective, double-blind, multicenter trial involving 472 women with pelvic mass who were scheduled for surgical intervention. Blood samples were obtained from these women to measure for levels of HE4 and CA125. Two separate algorithms for premenopausal and postmenopausal women stratified patients into low- and high-risk groups. All patients then underwent surgical removal of the pelvic mass, and if a patient was diagnosed with an epithelial ovarian cancer, surgical staging was required by protocol. All tissue specimens were examined to verify the diagnoses made by study site pathologists.
The combined HE4 and CA125 algorithm was found to be highly accurate in assigning patients to risk groups, with 95% of epithelial ovarian cancers correctly classified as high-risk.
The ROMA test, by improving the sensitivity and specificity of methods to stratify patients with ovarian cancer, is expected to help thousands of women determine their risk for ovarian cancer and enable those who are at risk to be referred to a gynecologic oncologist, a benefit that may improve treatment outcomes. ( Xagena )
Source: Women & Infants Hospital, 2011