Abcodia Suspends Ovarian Cancer Test Sales in U.S. Following FDA Warning

Published on November 3, 2016 by Sandy Liebhard

Abcodia, Inc. has suspended sales of its Risk of Ovarian Cancer Algorithm (ROCA) test in response to a recent Food & Drug Administration (FDA) warning against the use of such products. According to the FDA, ovarian cancer tests like ROCA are not backed by scientific evidence.

Ovarian cancer is the fifth leading cause of cancer death among women. According to the American College of Obstetricians and Gynecologists (ACOG), nearly 21,000 U.S. women were diagnosed with the disease in 2013, and more than 14,000 died from ovarian cancer. Unlike other cancers, ovarian tumors don’t have detectable pre-cancers, so the disease is usually not diagnosed until it has spread. Yet numerous companies have marketed tests that claim to screen for and detect ovarian cancer. A blood test known as C 125 is the most widely-used, and measures levels of a blood protein linked to the disease,

FDA Ovarian Cancer Test Warning

According to an FDA alert issued on September 7^th, there are currently no tests for ovarian cancer that are sensitive enough to reliably screen for the disease without a high number of inaccurate results.

“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,” the agency said “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.”

The FDA also voiced concern that the use of ovarian cancer tests may harm women at risk for the disease, as they and their doctors may not take appropriate actions to reduce their future risk if they rely on a result that shows no cancer currently present.

The ACOG and the Ovarian Cancer Research Fund Alliance have both voiced strong support for the FDA’s position.

ROCA Test

The ROCA test, which retails for around $295.00, uses a woman’s age, menopausal status, risk status and CA 125 measurements “to produce a score that indicates your likelihood of having ovarian cancer.”  The company claims that ROCA is far more accurate than a standard CA 125 test. However, the FDA maintains that the available data do not support the company’s claims.

Abcodia announced the U.S. sales suspension on September 17^th. However, the company continues to stand by ROCA, and has promised to work with the FDA, physicians and medical centers to evaluate the test.

“Abcodia is deeply committed to our dedicated partners including patients, clinicians, advocacy groups and professional societies, and we are grateful for the support we continue to receive from many individuals and groups,” the company said in a statement. “We encourage women concerned about their risk of ovarian cancer to speak with their physician and to take an active role in managing their health.”