Diagnostic assesses likelihood of malignancy in women with an ovarian mass for which surgery is planned.
Vermillion signs on Quest Diagnostics to make available in India OVA1, a diagnostic to assess the likelihood that an ovarian mass is malignant even when it is not indicated by a physician’s independent clinical and radiological evaluation. The companies are targeting a launch in the second quarter of this year.
Gail S. Page, president and CEO of Vermillion, says India “represents an outstanding market opportunity” given the approximately 350 million women in its population. “Vermillion is now poised for growth both domestically and internationally as we continue to develop our international strategy in concert with the efforts already under way in the U.S.”
OVA1 is the first protein-based in vitro diagnostic multivariate index assay (IVDMIA) cleared by the FDA. It uses software and five biomarkers—transthyretin (TT or prealbumin), apolipoprotein A-1 (Apo A-1), beta2-microglobulin (Beta2M), transferrin (Tfr), and cancer antigen 125 (CA 125 II).
OVA1 reportedly has a sensitivity for malignancy and when used in conjunction with ultrasound, sensitivity for malignancy was 97%, according to Fred Ueland, M.D., principal investigator of the multicenter OVA1 clinical trial.