The U.S. Food and Drug Administration (FDA) last month warned that any devices claiming to screen for ovarian cancer aren’t backed by scientific proof. The FDA urged women and physicians not to use the devices. Women should turn to their physicians if they fear ovarian cancer, not to tests like Abcodia Inc.’s new Risk of Ovarian Cancer Algorithm (ROCA) test, the FDA said. There’s no scientific evidence supporting ROCA, or other similar devices, that can properly detect the cancer, according to the agency. The agency said:
FDA is concerned that women and their physicians may be misled by such claims and rely on inaccurate results to make treatment decisions. Based on the FDA’s review of available clinical data from ovarian cancer screening trials and recommendations from health care professional societies and the U.S. Preventive Services Task Force, available data do not demonstrate that currently available ovarian cancer screening tests are accurate and reliable in screening asymptomatic women for early ovarian cancer.
The tests could either provide a false positive, in which a woman would go through unnecessary tests and surgeries, or a false negative, in which a woman wouldn’t seek necessary treatment. Additionally, negative tests could discourage women who either because of a gene mutation or family history are at a high risk of developing ovarian cancer from taking steps to decrease their risk, the FDA said. Ovarian tumors don’t have a detectable pre-cancer like with other cancers. This means ovarian cancer can’t be detected without invasive surgery at this time. The cancer, which is the fifth deadliest cancer for women in the U.S., is usually discovered after it has spread.
The American College of Obstetricians and Gynecologists and the Ovarian Cancer Research Fund Alliance (OCRFA) quickly voiced their support for the FDA’s announcement. These groups, in separate statements, said that while they would like to have a test, the medical community isn’t there yet. OCRFA President and CEO Audra Moran stated:
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.
I suspect these will be more developments in this matter. We have been dealing with ovarian cancer issues in the J&J litigation and know how deadly and devastating this cancer is for women.
Contact us today for a free legal consultation with an experienced attorney.
Fields marked *may be required for submission.
If you would like to subscribe to the Jere Beasley Report digital edition, simply visit our Subscriptions page and provide the necessary information or call us at 800-898-2034.
Attorney Advertising - Prior results do not guarantee a similar outcome.