FDAnews
www.fdanews.com/articles/175840-vermillion-awarded-fda-clearance-for-overa

Vermillion Awarded FDA Clearance for Overa

March 21, 2016

Austin, Texas-based Vermillion has earned FDA clearance for its blood test Overa — dubbed a successor to its OVA1 — for identifying ovarian cancer risk.

The test is intended for use in combination with clinical and imaging assessment before surgery in women with a pelvic mass, the company says.

Overa operates on a Roche Cobas 6000 platform. Further, it swaps two biomarkers from the original test out for human epididymal protein 4 and a follicle stimulating hormone to enhance specificity and minimize the need to determine menopausal status. — Anisa Jibrell