(Reuters) – Diagnostics company Vermillion Inc said a clinical trial of its blood test for detecting ovarian cancer showed the test had a high chance of correctly identifying patients with cancer.
The test, named OVA1, is a blood test for pre-surgical assessment of ovarian tumors for malignancy.
The OVA500 study enrolled 494 patients and focused on two particularly challenging subgroups – women with early-stage ovarian cancer, where approximately half of patients have a normal CA125 level, and pre-menopausal women, where the incidence of ovarian cancer is low and incidence of benign cysts is high.
“A key goal of the study was to investigate the challenging pre-menopausal setting, where benign cysts have a high incidence and early-stage cancer often goes undetected,” Chief Executive Gail Page said.
The test had 94% sensitivity in the pre-menopausal group, and 91% sensitivity in the early-stage ovarian cancer group. Overall, the test showed 96% sensitivity.
OVA1 also had a negative predictive value of 98%.
“OVA1 sensitivity and negative predictive value in the OVA500 study met or exceeded the levels reported in the pivotal trial, and confirmed the ability of OVA1 to detect a broad range of ovarian cancer subtypes,” said Page in a company statement.
“Detection of a broad range of cancer subtypes is essential in triage, since it directly increases overall sensitivity and decreases the likelihood of finding a malignancy in patients with a low-risk assessment,” Page added.
Further details from the study have been submitted for peer-reviewed publication and presentation. Vermillion said it plans to utilize important findings like these as a tool to continue driving adoption and reimbursement of OVA1.