publication date: Sep. 16, 2016

Abcodia Suspends Sale of Ovarian Cancer Screening Test After FDA Communication

By Laura Brawley

Abcodia Inc., a British company that manufactures a controversial ovarian cancer screening test, said it will temporarily suspend the availability of the product in the United States.

ROCA, also known as the Risk of Ovarian Cancer Algorithm, uses a blood test called CA-125 and patients’ history to determine their risk for developing ovarian cancer.

On Sept. 7, FDA recommended against the use of ovarian cancer screening tests.

“For women, including those at increased risk of developing ovarian cancer: 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,” FDA wrote in a statement.  “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.” 

The agency’s safety communication specifically mentioned the ROCA test (The Cancer Letter, Sept. 9).

“Over the years, numerous companies have marketed tests that claim to screen for and detect ovarian cancer,” FDA said. “For example, recently, Abcodia Inc. began marketing the Risk of Ovarian Cancer Algorithm 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. FDA is concerned that women and their physicians may be misled by such claims and rely on inaccurate results to make treatment decisions.”

Abcodia said that in response to FDA’s safety communication it would stop selling ROCA test.

“Notwithstanding our confidence … Continue reading 42-34 Abcodia Suspends Sale of Ovarian Cancer Screening Test After FDA Communication

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