Along with University of Kentucky, company showed that the test improved early-stage detection with CA-125 and found two new protein markers.
Vermillion says that use of its biomarker could help better identify women with ovarian cancer as well as improve early detection. The firm conducted three studies along with the University of Kentucky using it’s test.
The company’s study used a model comprising its biomarker panel that was trained on a set of 270 samples from the University of Kentucky. This model, the ovarian tumor triage test, was then used in a prospectively collected cohort of 709 women from Rigshospitalet in Copenhagen.
The study provided validation that the test can distinguish malignant tumors from benign pelvic masses, according to the company. Results also showed that the biomarker panel could more than double the number of ovarian cancer cases referred to a gynecologic oncologist, thereby improving survival rates and reducing the number of surgeries performed, Vermillion reports.
The second study found that the panel of biomarkers in combination with CA-125 could more accurately identify early-stage ovarian cancer than CA-125 alone, Vermillion adds. CA-125 is the only tumor marker for ovarian cancer currently available on the market. It, however, is not cleared for early-stage disease detection. When examining stage-1 disease, the combination of the two markers correctly identified 87% of the cancers.
In the third study, Vermillion and the University of Kentucky Chandler Medical Center used SELDI TOF-MS to analyze ovarian cyst fluids and identify the underlying proteins that could serve as potentially useful biomarkers for ovarian cancer. They found that calgranulin A and B, two proteins commonly found in malignant ovarian cysts, may be useful in helping diagnose and predict prognosis of ovarian cancer.
The company reported this data at the Society of Gynecologic Oncologists’ 39th Annual Meeting on Women’s Cancer in Tampa, FL.
