Maker of ROCA Ovarian Cancer Test Suspends U.S. Sales

Following last week's safety communication from FDA about ovarian cancer screening tests, the maker of the ROCA Test announces it is voluntarily and temporarily suspending U.S. availability.

In an update after last week's warning from FDA about ovarian cancer screening tests, Abcodia, which sells the ROCA Test, announced it is voluntarily suspending U.S. availability of the test.

In a statement sent to MD+DI on Tuesday, Abcodia referenced the FDA safety communication and wrote, "Notwithstanding our confidence in the clinical utility of the ROCA Test, we are voluntarily choosing to temporarily suspend its commercial availability in the United States."

FDA recommended against screening tests 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," the agency wrote.

Other medical societies, groups, and the U.S. Preventive Services Task Force have also recommended against screening tests.

In its statement, Abcodia noted, "As the FDA has stated, there are currently no ovarian cancer screening tests which have been cleared or approved. We have been communicating about the ROCA Test with the FDA for several months. As part of our mission to provide additional screening tools for this devastating disease, we will continue to engage with the FDA and we will continue to partner with community physicians and leading medical centers on ongoing clinical evaluation of the ROCA Test."

Emphasizing that the company's test is not a standalone diagnostic or the single assessment of whether surgery is the proper next step, Abcodia called the ROCA Test "a risk estimation tool . . . developed with the goal of identifying women with an elevated risk for ovarian cancer for referral to a gynecological cancer specialist." The test is described on the company's website as being intended for postmenopausal women between 50-85 years old and women with a higher risk between 35-85 years old.

The ROCA Test was studied in the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS), which included more than 200,000 patients over 15 years. Abcodia pointed out in its statement that the findings showed the ROCA Test, used with transvaginal ultrasound and clinical decision-making, has 85.8% sensitivity and 99.8% specificity for ovarian cancer.

"These data compare favorably with currently approved and widely adopted screening modalities used as an aid in the detection of other cancers, and support the clinical utility of the ROCA Test to aid physicians in clinical referral decision making," Abcodia wrote.

Until today's announcement, the ROCA Test was available in almost all U.S. states, as well as the United Kingdom. Abcodia noted in its statement that it plans to provide guidance on U.K. access to the test "within the next week."

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