Ovarian cancer screening to reach patients

Physicians refer to epithelial ovarian cancer as “the silent killer.” With few early symptoms, the disease often goes undetected until it has spread to other parts of the body and it’s too late for curative treatment. It ranks as the deadliest of all gynecological cancers, claiming approximately three of every four women in the United States diagnosed with the disease. Now a scientific team led by Gil Mor, M.D., Ph.D., associate professor of obstetrics, gynecology and reproductive sciences, has found a way to detect the disease in its earliest stages, and has teamed with biopharmaceutical companies to transfer this technology from the bench to the bedside.

In May 2005, Mor and colleagues, in an article in the Proceedings of the National Academy of Sciences, showed that abnormal concentrations of four cancer-related proteins—leptin, prolactin, osteopontin and insulin-like growth factor II—in blood samples could indicate the presence of epithelial ovarian cancer with 95 percent accuracy and 95 percent specificity. [See “Biomarkers Warn of a ‘Silent Killer’,” Autumn 2005.]

Since then they have added two other protein markers and the accuracy rate has risen to 98 percent and the specificity rate to greater than 99.6 percent. This means that only 20 of every 1,000 women screened will be mistakenly diagnosed as being cancer-free, while only four of every 1,000 screenings will yield false positives.

Now the research team is pursuing partnerships with biotech companies throughout the world to develop this technology commercially. Yale recently signed a licensing agreement with SurExam Life Science & Technology Co., a Chinese company founded in part by scientists trained at Yale, and negotiations are under way to license the technology to a new diagnostic company in Israel.

Mor predicts that the test will be available in the United States early this year, following the completion of a pivotal Phase II trial being conducted by the National Cancer Institute in partnership with Laboratory Corporation of America. He hopes that his blood screen will be routinely used to detect epithelial ovarian cancer. “At the beginning, we thought this test may be appropriate only for women at high risk, but we now see this test as becoming a more routine diagnostic for screening,” he said.