Published on Thursday, September 15, 2016 by Staff
On September 14th, 2016, Abcodia, the London-based, privately-held company that sells the ovarian cancer screening test described in the FDA’s recent Safety Communication, announced that it was halting sales of the test in the United States.
Abcodia’s ovarian cancer screening test, known and marketed as the “ROCA” (“Risk of Ovarian Cancer Algorithm”) test, measures the presence, and changes in levels, of CA-125 in the blood. CA-125 is a protein that is found in women with ovarian cancer and other people with cancers. However, other conditions can increase levels of CA-125 which can lead to “false-positive” test results for ovarian cancer. In its September 7th Safety Communication, the FDA stated:
“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.”
On September 8th, the American College of Obstetricians and Gynecologists ACOG) issued a statement supporting the FDA’s Safety Communication. As aprt of that Statement, ACOG announced:
“Unfortunately, the existing evidence does not support any test to effectively screen for ovarian cancer. More research is still needed. As stated in ACOG’s Committee Opinion, “The Role of the Obstetrician-Gynecologist in the Early Detection of Epithelial Ovarian Cancer,” at this time, there is no effective strategy for ovarian cancer screening. Available ovarian cancer screening tests, such as the Risk of Ovarian Cancer Algorithm (ROCA) test, are neither accurate nor reliable to screen asymptomatic women for early ovarian cancer. Currently, it appears that the best way to detect ovarian cancer is for both the patient and her clinician to have a high index of suspicion of the diagnosis in symptomatic women. Persistent and progressive symptoms such as an increase in bloating, pelvic or abdominal pain, or difficulty eating or feeling full quickly, should be evaluated.
If you have questions about ovarian cancer, screening tests or your health, we urge you to contact your health care provider.