FDA Recommends Against the Use of Ovarian Cancer Screening Test

Ovarian-CancerOn September 7, 2016 the FDA issued a letter to physicians as well as the public recommending against the use of screening tests for Ovarian Cancer. Below are excerpts from the FDA recommendation:

“The FDA is alerting women about the risks associated with the use of tests being marketed as ovarian cancer screening tests. The Agency is especially concerned about delaying effective preventive treatments for women who show no symptoms, but who are still at increased risk for developing ovarian cancer. Based on currently available information, the FDA recommends against using currently offered tests to screen for ovarian cancer.”

“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.”

“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.”

How many women Have Been Harmed by Inaccurate Test?

Ovarian Cancer Test Kits have been added to the Mass Tort Nexus Watch List for Emerging Litigations for 2017. This topic will be discussed at the November 11th-14th 2016  Mass Tort Nexus “Four Days to Mass Tort Success Course . ”



Share this Post: