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Vermillion Receives FDA 510(k) Clearance for Overa

NEW YORK (GenomeWeb) – Vermillion today said it has received US Food and Drug Administration 510(k) clearance for its Overa ovarian cancer test.

The test is a second-generation version of the company's OVA1 test, and like OVA1 is intended to aid clinicians in assessing whether a pelvic mass slated for surgery is likely malignant or benign. In the case of likely malignant masses, patients can then be passed on for surgery to a gynecologic oncologist, as opposed to having the surgery done by their regular Ob/Gyn.

"Many women still do not receive the proper initial treatment for ovarian cancer," Robert Coleman, a gynecologic oncologist at the University of Texas MD Anderson Cancer Center and lead author of a forthcoming clinical validation study on Overa, said in a statement. "Overa is specifically designed to help us know which patients are low risk for malignancy and to better identify patients who are at high risk for having a malignancy and, therefore, would benefit from care with a gynecologic oncologist."

Overa, which runs on the Roche Cobas 6000 platform, replaces two of the five OVA1 biomarkers with HE4 and FSH, which improves the specificity of the test and simplifies interpretation by eliminating the need for doctors to consider a patient's menopausal status when reading the test result.