FDA Recommends Against Currently Available Ovarian Screening Tests

September 12, 2016
Dave Levitan

The FDA issued a recommendation against the use of any currently available screening tests for ovarian cancer.

The US Food and Drug Administration (FDA) issued a recommendation against the use of any currently available screening tests for ovarian cancer. The recommendation was directed at both women and at clinicians, who are warned not to recommend or use any screening tests for ovarian cancer in asymptomatic women.

“Despite extensive research and published studies there are currently no screening tests for ovarian cancer that are sensitive enough to reliably screen for ovarian cancer without a high number of inaccurate results,” the FDA wrote. “However, over the years, numerous companies have marketed tests that claim to screen for and detect ovarian cancer.”

The most commonly used screening test is a CA-125 blood test, with one such tool marketed as the ROCA test (Abcodia Inc). There have been some promising studies with this test, though its effects on mortality have not been dramatic.

In one large study published in the Lancet in March 2016, more than 200,000 postmenopausal women aged 50 to 74 years were randomized to a multimodal screening program using the ROCA test, screening with transvaginal ultrasound, or no screening.

There were 1,282 cases of ovarian cancer over an 11.1-year follow-up period. A proportional hazards model showed a 15% reduction in mortality over years 0 to 14 with the ROCA screening test, but this did not reach significance (P = .10). The ultrasound screening also failed to significantly reduce mortality. There was, however, a significant reduction in death from ovarian cancer with ROCA (P = .021); most of that reduction occurred in years 7 to 14 rather than the first 7 years of screening.

Though this was deemed promising, the FDA pointed out that there remain significant false-positive rates that make the test’s use problematic. In that study, for each ovarian and peritoneal cancer detected by screening, two women in the ROCA group had false-positive surgery.

The FDA’s statement noted that clinicians should “consider referring women at high risk of developing ovarian cancer, including those with BRCA mutations, to a genetic counselor or gynecologic oncologist, or other appropriate health care provider for more specialized care.” The US Preventive Services Task Force is currently updating its ovarian cancer screening recommendations, but in 2012 it also recommended against screening in asymptomatic women.