Ovarian Cancer Screening Tests May Provide Inaccurate Results, FDA Warns

Federal health regulators are warning women and doctors not to use products marketed as ovarian cancer screening tests, indicating that there no devices on the market that are proven to be safe or effective, and the screening tests may provide inaccurate results. 

In a safety communication issued on Wednesday, the FDA expressed concern that women may receive false information from unapproved ovarian cancer screening tests, which may either lead them to incorrectly believe they have ovarian cancer when they do not, or delay treatment for the condition if they are told that they do not have it, when in fact they do.

The FDA indicates that no screening tests currently on the market are sensitive or reliable enough to screen for ovarian cancer accurately. The tests have a “high number of inaccurate results,” according to the agency, which can cause a misdiagnosis or failure to diagnose cancer in a timely fashion.

The warning highlights one recent test, the Risk of Ovarian Cancer Algorithm (ROCA) by Abcodia Incorporated, which has made claims that the test can detect ovarian cancer before symptoms appear, thus increasing the chances of survival. The FDA says there is no available data to support that claim.

Relying on the inaccurate test results could lead to health consequences, the FDA warns.

“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 warning indicates. “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.”

Ovarian cancer is a type of cancer that grows in or near the ovaries. It is the fifth leading cause of cancer-related death among U.S. women. An estimated 22,000 women will be diagnosed with ovarian cancer in the U.S. this year, according to data from the National Cancer Institute. The FDA considers women who have reached menopause, have a family history of ovarian cancer, and women with certain genetic mutations as having the highest risk.

While there are reliable screening tests for a number of other types of cancers, the FDA notes that ovarian cancer does not appear to have a pre-cancer that is currently detectable without the use of invasive surgery. In most cases, ovarian cancer has spread to other parts of the abdominal cavity before it is diagnosed. This makes it highly unlikely that a screening test for asymptomatic women would be effective.

The FDA is warning women not to rely on the tests and to consult a physician about ways to reduce their ovarian cancer risks. It is urging doctors not to recommend or use the tests and to consider referring women at high risk to a genetic counselor or gynecologic oncologist.

Talcum Powder Ovarian Cancer Concerns

The warning comes amid increasing concerns among women worldwide about the risk of ovarian cancer from talcum powder used around the genitals for feminine hygiene purposes, and many of the marketed cancer screening tests may be attempting to capitalize on fears among millions of women who have used products like Johnson’s Baby Powder and Shower-to-Shower body powder for years.

Awareness about the potential link between talcum powder and ovarian cancer has increased this year, following two landmark jury trials that each resulted in multi-million dollar damage awards against Johnson & Johnson for withholding information and warnings from women.

Thousands of women are now pursuing a Johnson’s Baby Powder lawsuit or Shower-to-Shower lawsuit, indicating that they have been diagnosed with ovarian cancer. In many cases, women indicate that evidence of talc has been found in ovarian tumors.

While talcum powder is most commonly associated with use to help prevent diaper rash and maintain smooth skin, Johnson & Johnson has encouraged women to apply the powder around their genitals or in their underwear after every shower to maintain “personal freshness.” However, studies have suggested that such use may increase the risk of ovarian cancer, as talc particles contained in the powder may migrate through the vagina, uterus and fallopian tubes.

As talcum powder ovarian cancer lawyers continue to review and file cases for women and families nationwide, it is widely expected that thousands of additional claims will be added to the litigation, but diagnosis must come from a doctor, not one of the unapproved ovarian cancer screening tests.