ROCA Test Effective or Accurate: FDA on Abcodia’s Risk of Ovarian Cancer Algorithm





ROCA Test Effective or Accurate? Can you rely on the Abcodia ROCA (Risk of Ovarian Cancer Algorithm) Test if you want to find out if you have ovarian cancer? Is it accurate? Can it really detect the early stages of ovarian cancer?

Well, if you ask the U.S. Food and Drug Admnistration (FDA), the ROCA Test is not accurate or reliable.

And, in a recent safety notice to women and physicians, the agency warned “that there is currently no safe and effective ovarian cancer screening test”.

This, of course, does not mean that there won’t be any accurate or effective screening tests in the FUTURE.

roca test effective

But as things stand now, the FDA is not recommending the use of ovarian cancer screening tests — such as the ROCA Test — to detect the disease.

From the FDA:


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. However, over the years, numerous companies have marketed tests that claim to screen for and detect ovarian cancer.

For example, recently, Abcodia Incorporated began marketing the Risk of Ovarian Cancer Algorithm (ROCA) test in the United States, with claims that the ROCA test can screen for and detect ovarian cancer before symptoms appear and increase the chance for survival. Yet, available data do not support its claims.

The FDA goes on to say that a false positive reading may misled women to undergo an unnecessary treatment. Conversely, a false negative may result in would-be patients delaying or, worse, foregoing a necessary treatment. More from the FDA:

For example, some women may receive test results that suggest ovarian cancer even though no cancer is present (a false-positive). These women may undergo additional medical tests and/or unnecessary surgery, and may experience complications related to both. Or, test results may not show ovarian cancer even though cancer is present (a false-negative), which may lead women to delay or not seek surgery or other treatments for ovarian cancer.

In closing, here’s what the FDA recommends to women who are considering the idea of doing the ROCA Test:

  • Be aware that there is currently no safe and effective ovarian cancer screening test.
  • Do not rely on ovarian cancer screening test results to make health or treatment decisions.
  • Talk to your doctor about ways to reduce your risk of developing ovarian cancer, especially if you have a family history of ovarian cancer, or have the BRCA1 or BRCA2 genetic mutations.

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