Imaging and Blood Test Work Together to Optimize Evaluation of Ovarian Cancer Risk

A new US Food and Drug Administration (FDA)-cleared blood test that measures the levels of five proteins and then uses a proprietary algorithm and software to calculate a single risk score has been the topic of recent research comparing the test to two imaging modalities.

Findings from a new study of OVA1 clinical performance was published online February 14, 2014, in the American Journal of Obstetrics & Gynecology. The study examined the relationship between two typically used imaging modalities (ultrasound (US) and computed tomography (CT)) and the OVA1 test result, in assessing the risk of ovarian cancer among patients planning surgery for an ovarian mass.

“This new study advances our understanding of how OVA1 and imaging work together in the presurgical assessment of ovarian cancer risk,” said study coauthor Fred Ueland, MD, associate professor of gynecologic oncology at the University of Kentucky’s Markey Cancer Center. “This is important for two reasons. First, adding OVA1 reduced the number of ovarian cancers missed with imaging alone, by 85%–90%. Recent [studies] have reenforced that the first surgery is an important opportunity to improve ovarian cancer survival by ensuring that cancers are detected earlier and that they are operated on by the most experienced specialists. Second, this study provides new evidence of how menopausal status, imaging and OVA1 score may interrelate.”

Dr. Scott Goodrich, from the University of Kentucky (Lexington, USA), led the study in collaboration with colleagues Drs. Fred Ueland and Rachel Ware Miller. The findings are the third in a series of subset analyses of data obtained from 1,100 ovarian mass surgery patients in two earlier pivotal trials of OVA1 clinical performance, conducted in 2007 and 2012. The authors compared the performance of each imaging method alone, to the performance of OVA1 alone (for risk stratification), as well as in combination with OVA1. The blood test uses a proprietary algorithm and software called OvaCalc to calculate the risk score.

Furthermore, the authors presented logistic regression models demonstrating how menopausal status, high- or low-risk imaging and OVA1 score interact in the evaluation of ovarian cancer risk. The researchers concluded that “serum biomarkers and imaging are a complementary set of clinical tools and that when the [OVA1] score is further stratified by imaging risk and menopausal status, there is a better understanding of the clinical risk of ovarian malignancy.”

This latest study brings the number of full research articles on OVA1 clinical performance to a total of five peer-reviewed publications. Combined, these data provide strong, prospective clinical evidence that OVA1 improves the presurgical detection of ovarian cancer, regardless of stage or subtype, in patients undergoing surgery for a suspicious ovarian mass.

“The sensitivity of OVA1 is critical to the detection of ovarian malignancy, presurgical risk assessment, and determining whether a woman may benefit from consultation with a gynecologic oncologist prior to surgery,” said Donald Munroe, chief scientific officer and senior vice president of business development at Vermillion, Inc. (Austin, TX, USA), the developer of the test. “Vermillion is committed to fully developing this clinical evidence, together with future studies on how OVA1 may impact the efficiency and quality of care for women facing ovarian cancer, the deadliest of all gynecologic malignancies.”

Leading medical associations advise that women with suspected ovarian cancer be referred to a gynecologic oncologist for surgery for the best potential outcomes. However, only an estimated one-third of women who have a malignant tumor are operated on by a gynecologic oncologist for the initial removal of cancer.

Related Links:
University of Kentucky
Vermillion