Ovarian Cancer Test Wins FDA Approval

LEXINGTON, Ky. (Sept. 25, 2009) − A blood test that can help assess women's risk of ovarian cancer prior to surgery has been given FDA clearance, following a multisite clinical trial led by a University of Kentucky researcher.

OVA1 is the first FDA-cleared laboratory test that can indicate the likelihood of ovarian cancer with high sensitivity prior to biopsy or exploratory surgery, even if radiological test results fail to indicate malignancy. The test was developed by Vermillion Inc., a molecular diagnostics company, in cooperation with Quest Diagnostics. The OVA1 test will be available for physician use later this year.

"When combined with other clinical information, the OVA1 biomarker panel can help assess the likelihood of malignancy of an ovarian tumor before surgery and facilitate decisions about referral to a gynecologic oncologist," said Dr. Frederick R. Ueland, associate professor of gynecologic oncology at the University of Kentucky College of Medicine and a gynecologic oncologist at the Markey Cancer Center. Ueland was principal investigator of the prospective, multi-center OVA1 clinical trial.

"The national expertise in ovarian cancer and the resources of the Markey Cancer Center initially attracted Vermillion to the University of Kentucky," Ueland said. "After an impressive performance in the recent clinical trial, the test is now ready for immediate integration into every day practice to help improve outcomes for women with ovarian cancer. It is a triumph to see industry and academics unite to advance the practice of medicine."

The OVA1 test measures the levels of five well-established biomarkers and combines the results into a single numerical score. It is indicated for women over 18 who have an ovarian adnexal mass for which surgery is planned, but who have not yet been referred to an oncologist. The test provides a new option in the pre-operative evaluation to help physicians assess if a pelvic mass is benign or malignant in order to help determine whether to refer a woman to a gynecologic oncologist for surgery. Numerous clinical practice guidelines recommend that women with ovarian cancer be under the care of a gynecologic oncologist. However, only an estimated one-third of women who undergo surgery for possible ovarian cancer are referred to these specialist surgeons for their surgery.

Ovarian cancer is the leading cause of death from gynecologic cancers in the United States and the fifth-leading cause of cancer deaths in women. An estimated 21,600 new cases of ovarian cancer will be diagnosed in the United States in 2009, and around 14,600 women will die of the disease.