Ovarian Cancer Screening Test

An ovarian cancer screening test, such as the Risk of Ovarian Cancer Algorithm test, aka the ROCA test, is supposed to aid in the early detection of what is often a deadly disease. However, U.S. health regulators have voiced concern that these tests are often inaccurate, and  may actually place many women in harms way.

Detecting Ovarian Cancer

Ovarian cancer is the fifth leading cause of cancer death among women. According to the National Cancer Institute, more than 22,000 women between ages 35 and 74 could be diagnosed with the disease this year. Those most at risk include women in menopause, those who have a family history of ovarian cancer, and women with the BRCA1 or BRCA2 genetic mutations.

The five year survival rate for ovarian cancer is above 90% when it is detected early. Unfortunately, this occurs only about 20% of the time. As a result, almost 15,000 women die every year from the disease.

When screening for ovarian cancer, doctors often order a test called the CA-125 blood test in conjunction with an ultrasound. CA-125 is a blood protein that occurs at high levels in women with cancer. But a high level can also signal other conditions, including cirrhosis, pelvic inflammatory disease, fibroids, or endometriosis. What’s more, half of women with early cancer have a normal CA-125 level.

One of the most heavily marketed ovarian screening tests is the Risk of Ovarian Cancer Algorithm test, or the ROCA test, manufactured by Abcodia, Inc.  The test costs around $295.00, and 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.”  Abcodia claims that its ovarian cancer screening test is more accurate than a standard CA-125 test, but U.S. health regulators have recently cast doubt on those claims.

FDA Recommends against Use of Ovarian Cancer Screening Tests

In September 2016, the U.S. Food & Drug Administration (FDA) recommended against the U.S. of ovarian cancer screening tests, warning that they are not backed by scientific evidence.

“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,” the agency said. “However, over the years, numerous companies have marketed tests that claim to screen for and detect ovarian cancer.”

The FDA’s alert specifically cited Abcodia’s ROCA test as an example, and maintained that available data do not support claims that the test can screen for and detect ovarian cancer before symptoms appear and increase the chance for survival.

According to the FDA, unreliable ovarian cancer screening tests may:

  • Produce false-positive results, which could cause women to undergo additional medical tests and/or unnecessary surgery for cancer that does not exist.
  • Produce a false-negative ovarian cancer result, which may lead women to delay seeking surgery or other treatments for the disease.
  • Be harmful to women at increased risk for ovarian cancer, as they or their doctors may not take appropriate actions to reduce their future risk if they rely on a result that shows no cancer currently present.

Within days of the FDA warning, Abcodia announced that it would suspend U.S. sales of the ROCA test, though it continues to stand by the product.  Read More

  1. National Cancer Institute (2014) “A Snapshot of Ovarian Cancer” https://www.cancer.gov/research/progress/snapshots/ovarian
  2. FDA (2016) “The FDA recommends against using screening tests for ovarian cancer screening: FDA Safety Communication” http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm519413.htm
Last Modified: November 4, 2016

Get the latest news and litigation updates about this case by following us on Facebook. Click the "Like" button below.


Follow Us

RXInjuryHelp.com on Google+  RXInjuryHelp.com on Facebook  RXInjuryHelp.com on LinkedIn  RXInjuryHelp.com on Twitter  RXInjuryHelp.com on YouTube  RXInjuryHelp.com on Pinterest

Skip to content