Ovarian Cancer

Novel blood test for more accurate diagnosis of ovarian cancer

Ovarian cancer is the fifth-leading cause of cancer death among women, leading to approximately 15,000 deaths each year in the US. The majority of new cases diagnosed each year, are diagnosed in the late stages of the disease when the cancer has spread beyond the ovary, leading to a poor prognosis.

Ovarian cancer is a difficult cancer to diagnose since many of the symptoms are confounding and can be related to other illnesses (bloating, abdominal pain, frequent urination, etc.), thus delaying the diagnosis further. More than 250,000 women present to their physician each year with an undiagnosed pelvic mass, yet there is still no reliable tool to differentiate malignant disease from other benign gynecologic conditions, making early detection a significant challenge. Nevertheless early detection does have a significant impact on prognosis with a 90% cure rate following surgery and/or chemotherapy if detected at localized stage 1.

CA125 is the current gold standard test for the management of ovarian cancer. It is used to monitor patients for recurrence and for response to therapy and treatment. CA125 is elevated in about 80% of women with ovarian cancer, however not all elevations indicate a malignancy. CA125 can be elevated in non-cancerous conditions such as menstruation, endometriosis, pregnancy, pelvic inflammatory disease, and benign ovarian cysts and is therefore not recommended for use to diagnose patients with suspected ovarian cancer.

Using its combined MASStermind^® and MASSterclass™ biomarker discovery engine Pronota is identifying and developing new biomarkers that either function as stand-alone diagnostic tests or that can complement CA125 to increase its sensitivity and specificity. Pronota aims to have a high quality test with required predictive value to risk stratify women with a pelvic mass as high or low risk of having invasive disease.

An unbiased MASStermind^® discovery study was set-up so that early diagnostic biomarkers as well as biomarkers specific for invasive or late stage tumors were identified. A European multicenter clinical validation trial is currently ongoing to screen the selected biomarker hits in a larger population. Single biomarkers as well as biomarker panels will be scored for their performance as risk stratification biomarkers in women presenting with a pelvic mass.