In a news release, the FDA says the test helps patients and health care professionals decide what type of surgery should be done and by whom -- but not to screen for ovarian cancer and not for a definitive diagnosis of ovarian cancer.
"The OVA1 test identifies some women who will benefit from referral to a gynecological oncologist for their surgery, despite negative results from other clinical and radiological tests for ovarian cancer. If other test results suggest cancer, referral to an oncologist is appropriate even with a negative OVA1 result," the FDA states.
The FDA says the OVA1 test should be used by primary care physicians or gynecologists to complement, but not replace, other diagnostic and clinical procedures.
OVA1 uses a blood sample to test for levels of five proteins that change because of ovarian cancer. The test combines the five separate results into a single numerical score between 0 and 10 to indicate the likelihood that the pelvic mass is benign or malignant.
OVA1 is only intended for women aged 18 and older who are already selected for surgery because of their pelvic mass. Interpreting test results requires knowing whether the woman has gone through menopause.
The FDA notes that in 2002, the American College of Obstetricians and Gynecologists and the Society of Gynecologic Oncologists published recommendations for obstetrician-gynecologists about the early detection of ovarian cancer, which included a recommendation that patients get referred to a gynecological oncologist when specific indicators of malignancy are present.
These recommendations and later reports indicate that patients with ovarian cancer have improved survival when their surgery is performed by gynecologic oncologists, as opposed to general gynecologists or surgeons, according to the FDA.
"Tests such as OVA1 personalize and improve public health by providing patients and health care providers more information to support medical decisions that impact survival rates and reduce surgical complications," Jeffrey Shuren, MD, JD, acting director of the FDA’s Center for Devices and Radiological Health, says in a news release.
The FDA cleared the OVA1 test based on a study of 516 patients, including 269 patients evaluated by non-gynecological oncologists, which compared OVA1 results with biopsy results. When combined with pre-surgical information, such as radiography and other laboratory tests, results from the OVA1 tests identified additional patients who might benefit from oncology referral who were not identified using pre-surgical information alone.
The OVA1 test was developed by Vermillion Inc., of Fremont, Calif., in conjunction with researchers at The Johns Hopkins University in Baltimore.