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Diagnostics Makes OVA1 Blood Test Nationally Available

Quest Diagnostics, a provider of cancer diagnostics, has made OVA1, the blood test cleared by the FDA for aiding in the pre-surgical evaluation of a woman's ovarian mass for cancer, available nationally.

With the availability of OVA1, physicians can assess, prior to a planned surgery, the likelihood that a woman’s ovarian mass is malignant in order to direct her to the most appropriate surgeon, promoting favorable treatment outcomes. Vermillion, a molecular diagnostics company, developed the test in cooperation with Quest Diagnostics.

OVA1 is the protein-based in vitro diagnostic multi-variate index assay (IVDMIA), a new class of software-based diagnostics. The test combines the results of five well-established protein biomarkers to produce a single numerical result to help a physician classify the likelihood that a woman’s mass is cancerous or benign.

In a prospective clinical study, OVA1, when combined with pre-surgical clinical and radiological assessments and used by non-gynecologic oncologists, detected 92% of malignant ovarian masses compared to 72% without OVA1. In addition, 14 of 20 woman who participated in the study whose cancer was missed by pre-surgical clinical and radiological assessments would have been identified as having malignant ovarian masses had OVA1 results also been evaluated prior to their surgeries.

OVA1 is the protein-based in vitro diagnostic multi-variate index assays (IVDMIA), a new class of state of the art 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 following criteria: 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.

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.

Karen Orloff Kaplan, chief executive officer of the Ovarian Cancer National Alliance, a patient advocacy group, said: “The availability of a new test that can help gynecologists and other physicians determine the likelihood a woman’s mass is benign or malignant is a development in the battle against this devastating disease. It is a step towards helping each woman get the appropriate care for her situation.”