WebMD Medical News
Louise Chang, MD
Sept. 11, 2009 -- The FDA approved a new ovarian cancer blood test, called
OVA1, that can help detect ovarian cancer in a pelvic mass that is already
known to require surgery.
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
"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
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
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
"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.
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