On September 7th, the FDA issued an important safety communication about tests marketed as ovarian cancer screening tests, including the ROCA Test developed by Abcodia Incorporated. The FDA states, “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.”
In January 2016, Ovarian Cancer Research Alliance (OCRFA) convened a group of experts to discuss the science behind the ROCA Test. The outcome of that meeting, summarized here, was that screening for ovarian cancer with the approach used in the ROCA Test is not effective in preventing women from dying from ovarian cancer.
“We all wish there were an effective screening test for ovarian cancer. Unfortunately, we haven’t yet found a test proven to save women’s lives. We share the FDA’s concern that the ROCA Test, which is being marketed directly to women in 47 states, may do more harm than good. The money spent marketing tests of questionable benefit would be much better spent on research to find an effective test, better treatments and a cure,” said Audra Moran, president and CEO of Ovarian Cancer Research Alliance.
To read the full communication from the FDA, click here.
