FREMONT, Calif., Feb. 13 (UPI) -- U.S. firm Ciphergen Biosystems said Tuesday it has begun a trial of its test that differentiates between ovarian cancer and benign tumors.
The company said that, depending on the cancer prevalence within the study population, it would enroll 700 to 1,000 patients at about 20 sites.
The goal of the study is to show that the test's ability to distinguish ovarian cancer from benign cases is superior to the current standard of care, physical and radiological examination.
Ciphergen said it would seek approval of the product from the Food and Drug Administration as an in vitro diagnostic test.
"Physicians currently have no reliable way to distinguish between a benign and malignant ovarian tumor prior to performing surgery for a known pelvic mass," said lead investigator Frederick Ueland, associate professor of obstetrics and gynecology at the University of Kentucky. "This triage test could help identify women with ovarian cancer so they can be referred directly to a gynecological oncologist for treatment."
He added, "Studies have shown that women with ovarian cancer have an improved median survival of six to nine months when their initial surgery is performed by a gynecological oncologist, compared to a general surgeon. This triage test could potentially reduce the number of surgeries performed by seeing the appropriate specialist first."
