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Vermillion And The OVA1 Experience

OVA1 is the first blood test cleared by the FDA to help a physician evaluate the likelihood that a woman's ovarian mass is malignant or benign prior to a planned surgery. The proteomics-based test utilizes a panel of five biomarkers that may help identify women with cancer so they can be referred directly to a gynecologic oncologist for their initial surgery. Its developer, Vermillion Inc., has been successful in obtaining a new CPT code specific to its test and has successfully approached several payors to garner positive coverage as well as a beneficial price point. Although OVA1 is not yet covered universally, they are swiftly moving in the right direction.

As of 2010, although OVA1 had already received FDA 510K clearance a year earlier, Vermillion was deemed to have insufficient...

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