The FDA has given 510(k) clearance to Fujirebio Diagnostics to market the company's test to detect whether the silent killer of ovarian cancer is stalking women who come into physicians' offices with ovarian cysts. The combination blood test for proteins HE4 and CA125 and an algorithm called ROMA were developed by Richard G. Moore at Women & Infants Hospital of Rhode Island.
"Using ROMA with HE4 and CA125 significantly improves our ability to identify women who are at high or low likelihood of ovarian cancer when they present with an ovarian cyst or mass," Moore said in a release. The results of the test will determine where the woman will be treated, he said. If the test comes back positive for cancer, then the cyst would best be removed by a gynecologic oncologist.
"Of the 300,000 women that undergo surgery for a pelvic mass, 10% to 20% are discovered to have cancer," Moore told the Providence Journal. "Having women triaged to the right surgeons is very important. It gives them a survival advantage." And, he added, women with low risk should remain "in their communities with the doctors that know them best."
The Journal points out that the ROMA test, while helpful, is not the longed-for screening test for early detection of ovarian cancer in early, more-treatable phases. Such a test would be welcome, since ovarian cancer does not produce any symptoms as it grows to lethal levels.
- read the release from Women & Infants Hospital
- and the Providence Journal report