What's Behind FDA's Warning Against Ovarian Cancer Screening Tests?

Posted in Regulatory and Compliance by mthibault on September 9, 2016

FDA has recommended against the use of ovarian cancer screening tests. Why did the agency make this major statement?

Marie Thibault

Earlier detection of cancer is a good thing, right? So why did FDA just warn against ovarian cancer screening tests? 

This week, the agency published a safety communication warning against using currently available ovarian cancer screening tests. The recommendation, which came during Ovarian Cancer Awareness Month, is because "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," FDA wrote.

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By coming down hard on ovarian cancer screening, FDA joins other medical professional societies and groups. The Choosing Wisely initiative, run by the American Board of Internal Medicine (ABIM) Foundation, offers information on ovarian cancer screening tests, stating that "results are not always effective" and that they can lead to dangerous, unnecessary, and costly procedures. Choosing Wisely does point out that a CA-125 test and ultrasound can be useful if a woman has ovarian cancer symptoms or is at high risk.

The U.S. Preventive Services Task Force also recommends against ovarian cancer screening, giving it a "D" grade.

Ovarian cancer screening tests usually include measurement of the protein cancer antigen 125 (CA-125). The CA-125 test is used to monitor ovarian cancer during and after treatment, but is not recommended for screening because a high level can be caused by a variety of conditions (even menstruation) and a normal level is often seen in patients with early-stage cancer, according to Choosing Wisely.

FDA wrote that it is concerned about the impact of false-positives and false-negatives from screening tests, noting that "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 agency added that women at higher risk of ovarian cancer may also be harmed by "unproven ovarian cancer screening tests"  because a test result showing no cancer may dissuade them from doing anything to reduce their risk.

In addition to its recommendation against screening tests, FDA urged women with a higher risk of ovarian cancer to "be aware that there is currently no safe and effective ovarian cancer screening test" and not to depend on screening test findings.

Cambridge, UK-headquarted Abcodia makes the ROCA test, marketed as a way to determine the likelihood of ovarian cancer in postmenopausal women between 50-85 years old and women with a higher risk between 35-85 years old. According to the corporate website, the ROCA test is available in the United Kingdom, as well as almost all U.S. states.

Information on Abcodia's corporate website markets the benefits of the test, including detection of 85.8% of ovarian cancers, 99.8% efficacy in determining women who do not have ovarian cancer, and detection of twice as many ovarian cancers as the CA-125 blood test. But the company also acknowleges the "limitations" of the ROCA test, including that "up to 14.2% of women with ovarian cancer may be missed" and that it should not be the only test used to decide whether a patient should have surgery.

Data on the ROCA test comes from clinical trials, including the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS), which included more than 200,000 patients. Though UKCTOCS involved about 15 years of research, some onlookers were critical. A June 2016 editorial in the American Family Physician claimed the results "did not show convincing effectiveness" because the mortality reduction was not statistically significant, was not constant, and only a quarter of patients were subject to followup long enough to show potential benefit. 

Abcodia did not have a statement on FDA's communication available at press time, but this article will be updated for any comment from the company. [Editor's note: On September 13, Abcodia said in a statement it is voluntarily and temporarily suspending U.S. commercial availability of the ROCA Test. Read more here.]

Another company that makes an ovarian cancer-related test—not a screening test—praised FDA's decision. ASPiRA Labs, a Vermillion company, makes the OVA1 and OVERA FDA-cleared tests to evaluate risk of malignant ovarian cancer in women slated for surgery for pelvic mass. 

“We believe this clarity around the use of non-FDA approved test for ovarian cancer screening, demonstrates the need to manage high risk pelvic mass patients at the onset with our FDA cleared technology,” Valerie Palmieri, president and CEO of Vermillion/ASPiRA Labs, said in a release

The Ovarian Cancer Research Fund Alliance (OCRFA) cheered FDA's statement this week. "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," said Audra Moran, OCRFA president and CEO, in a release. "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." 

Marie Thibault is the managing editor at MD+DI. Reach her at and on Twitter@medtechmarie.


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