An In Vitro Diagnostic Multivariate Index Assay (IVDMIA) for Ovarian Cancer: Harvesting the Power of Multiple Biomarkers.

Abstract

In this review, OVA1® (Vermillion, Inc., Austin, TX), the first in vitro diagnostic multivariate index assay (IVDMIA) of protein biomarkers cleared by the US Food and Drug Administration (FDA), is used to explain the concept behind IVDMIA, the use of multiple markers to improve clinical performance of a diagnostic tool, and the key considerations in the development of IVDMIA.