Home 5 Clinical Diagnostics Insider 5 FDA Recommends Against Ovarian Cancer Screening and Industry Emphasizes Risk-Based Testing

FDA Recommends Against Ovarian Cancer Screening and Industry Emphasizes Risk-Based Testing

by | Oct 26, 2016 | Clinical Diagnostics Insider, Diagnostic Testing and Emerging Technologies, Top of the News-dtet

The U.S. Food and Drug Administration (FDA) recommends against using currently available tests to screen for ovarian cancer, according to a safety communication the agency issued at the beginning of September. The FDA says there are risks associated with currently marketed, but not approved, ovarian cancer screening tests and the agency is especially concerned about inaccurate results that may delay effective, preventive treatments for asymptomatic women at increased risk for developing ovarian cancer. Despite the fact that ovarian cancer is the fifth-leading cause of cancer-related deaths among women, there is no approved or recommended screening test for the disease. Yet, cancer antigen (CA) 125 tests are extensively used. "From what we know anecdotally, in spite of the fact that CA 125 isn’t really meant to be used that way, many women who are concerned about the risk of ovarian cancer are getting the test every year,” Sarah DeFeo, vice president of scientific affairs for the Ovarian Cancer Research Fund Alliance, told STAT News. "In practice, lots of people are doing it." Current recommendations against screening for ovarian cancer are based on the large U.S. Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial, which found that annual CA 125 measurement […]

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