FDA clears biomarker test for R.I. oncologist

PROVIDENCE – The U.S. Food and Drug Administration approved marketing and use of biomarker tests developed by a research team led by Dr. Richard G. Moore, a gynecological oncologist at Women & Infants Hospital.
The new diagnostic tool, which combines blood tests with an algorithm, has high accuracy in determining the risk of ovarian cancer in women with a pelvic mass.
The new diagnostic tool is being marketed by Fujirebio Diagnostics Inc., a Japanese company with U.S. headquarters in Malvern, Penn. The firm is a leader in cancer biomarker assays. The diagnostic tool employs blood tests to examine levels of proteins HE4 and CA125, then uses the Risk of Ovarian Malignancy Algorithm determine with great accuracy ovarian cancer risk in pre- and post-menopausal women.
“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,” said Moore, who directs the hospital’s Center for Biomarkers and Emerging Technology. Moore is also an assistant professor of obstetrics and gynecology at the Warren Alpert Medical School of Brown University.
Ovarian cancer is called a “silent killer” because it is difficult to diagnose as symptoms can easily be 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, more than 90 percent will live past five years. However, only one quarter of cases are diagnosed in the early stages. “This combination test will change the way doctors diagnose and treat ovarian cancer,” Moore said.
Moore’s research was presented at this year’s annual meeting of the Society of Gynecologic Oncologists and published in the August 2011 issue of Obstetrics and Gynecology, the journal of the American Congress of Obstetricians and Gynecologists.