Vermillion, a developer of in-vitro diagnostic tests, has reported that Medicare will cover its OVA1 test to help assess the likelihood that an ovarian mass is benign or malignant. Highmark Medicare Services is the CMS contractor that processes Medicare claims for OVA1. Highmark announced its decision to cover this new service.
Vermillion’s OVA1 is a protein-based in vitro diagnostic multi-variate index assay (IVDMIA), a new class of software-based diagnostics, cleared by the FDA. The test utilizes five well-established biomarkers Transthyretin (TT or prealbumin), Apolipoprotein A-1 (Apo A-1), Beta2-Microglobulin (Beta2M), Transferrin (Tfr) and Cancer Antigen 125 (CA 125 II) and software to determine the likelihood of malignancy in women with ovarian mass for whom surgery is planned.
OVA1 is indicated for women who meet the criteria like: over age 18, ovarian adnexal mass present for which surgery is planned, and not yet referred to an oncologist. It is an aid to further assess the likelihood that malignancy is present when the physician’s independent clinical and radiological evaluation does not indicate malignancy.
Vermillion said that the test should not be used without an independent clinical/radiological evaluation and is not intended to be a screening test or to determine whether a patient should proceed to surgery. Incorrect use of the OVA1 Test carries the risk of unnecessary testing, surgery, and/or delayed diagnosis.
Gail Page, CEO of Vermillion, said: “We are pleased with this favorable decision, which will help provide access to this important test to the many women with ovarian masses. This decision by Highmark Medicare Services reaffirms our belief that OVA1 can provide meaningful clinical information to assist physicians in identifying women with a high likelihood of having malignancy prior to planned surgery.”
Based in Fremont, California, Vermillion involves in the development and commercialization of high-value diagnostic tests that help physicians diagnose, treat and improve outcomes for patients. Vermillion, along with its scientific collaborators, has introduced diagnostic programs in oncology, hematology, cardiology and women’s health.