FDA Clears OVA1 Test to Determine Ovarian Cancer Risk in Women With Pelvic Mass

The US Food and Drug Administration (FDA) recently cleared the OVA1 Test, the first blood test that, prior to surgery, can help physicians determine if a woman is at risk for a malignant pelvic mass. 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 radiologic test results fail to indicate malignancy. The test was developed by Vermillion, Inc, a molecular diagnostics company, in cooperation with Quest Diagnostics.

Five Immunoassays
“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 Frederick R. Ueland, MD, principal investigator of the prospective, multicenter OVA1 clinical trial and associate professor of gynecologic oncology at the University of Kentucky’s Markey Cancer Center.

The OVA1 Test is an in vitro diagnostic multivariate index test that combines the results of five immunoassays using a proprietary unique algorithm to produce a single numerical score indicating a women’s likelihood of malignancy. The OVA1 Test provides a new option in the preoperative 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.

The OVA1 Test will be available for physician use in the fourth quarter of this year.