Armed with a novel blood test, physicians at Women & Infants Hospital of Rhode Island have access to a new tool to fight ovarian cancer. The novel biomarker HE4 was recently cleared by the U.S. Food and Drug Administration (FDA) for ovarian cancer monitoring. Women & Infants’ Division of Medical Screening and Special Testing is one of only a few laboratories in the country currently offering this test.
Historically, the serum biomarker CA125 has been the “gold standard” for monitoring women with ovarian cancer. However, CA125 levels are elevated in only 50% of women with early stage disease and lack the sensitivity and specificity for ovarian cancer risk assessment when used on its own.
In a multicenter trial funded by Fujirebio Diagnostics Inc. and published last year, lead researcher Richard G. Moore, MD, director of the Center for Biomarkers and Emerging Technology (CBET) at Women & Infants, demonstrated that the combination of blood tests for CA125 and HE4 levels could predict with high accuracy if an ovarian cyst or pelvic mass was cancerous using the Predictive Probability Algorithm, a statistical model. The use of this algorithm as an adjunct to clinical assessment can help physicians triage women at high risk for ovarian cancer to specialists for treatment.
Women & Infants’ Division of Medical Screening and Prenatal Testing is one of the few laboratories in the country certified by Clinical Laboratory Improvement Amendments (CLIA) to offer HE4 testing and the only laboratory in the country offering the Predictive Probability Algorithm.
“We are currently receiving blood for testing from all over the United States and the world,” Dr. Moore said.