Serum Test for Ovarian Cancer Helps Determine Type of Required Surgery

The test is indicated for women who meet the following criteria: the patient is over age 18, an ovarian adnexal mass is present for which surgery is planned, and the patient has not yet been referred to an oncologist.

The immunoassay identifies 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). An algorithm is then used to determine the likelihood of malignancy in women with pelvic mass for whom surgery is planned.

OVA1test was developed by Vermillion, Inc. (Freemont, CA, USA) a molecular diagnostics company, in cooperation with Quest Diagnostics (Madison, NJ, USA), a provider of cancer diagnostics. Quest Diagnostics has exclusive rights to offer the test to the clinical reference laboratory market in the U.S. for three years. The U.S. Food and Drug Administration (FDA) has cleared the OVA1 test, as an indication of ovarian cancer with high sensitivity prior to biopsy or exploratory surgery, even when radiological test results fail to indicate malignancy.

The test should not be used without an independent clinical/radiological evaluation. It 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.

Vermillion, Inc. is dedicated to the discovery, development, and commercialization of novel high-value diagnostic tests that help physicians diagnose, treat, and improve outcomes for patients. Vermillion has diagnostic programs in oncology, hematology, cardiology, and women's health.

Quest Diagnostics is a provider of diagnostic testing, information, and services that patients and doctors need to make better healthcare decisions. The company offers access to diagnostic testing services through its network of laboratories and patient service centers, and provides interpretive consultation through its medical and scientific staff.

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