New Delhi, Delhi India (PressExposure) May 13, 2011 -- Quest Diagnostics, the world's leading provider of diagnostic testing, information and services, announced that it has introduced in India OVA1, the first blood test cleared by the U.S. Food and Drug Administration (FDA) for aiding in the pre-surgical evaluation of a woman's ovarian mass for cancer.
With the availability of OVA1, physicians in India 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 more favorable treatment outcomes. Vermillion, Inc. (Nasdaq: VRML), a molecular diagnostics company, developed the test in cooperation with Quest Diagnostics.
"Under normal circumstances, a physician cannot know if an ovarian mass is caused by cancer until she operates and tests it," said Dr. Palat Menon, Senior Director, Medical and Clinical Trials, Quest Diagnostics India. "Now, even before the surgery, based on a blood sample, OVA1 can measure the levels of five proteins, and then use proprietary computer software to indicate the probability of cancer in an ovarian mass."
"Ovarian cancer is a silent killer, because its symptoms are very nondescript," said Dr. Eric T. Fung, Senior Vice President and Chief Scientific Officer at Vermillion. "The introduction of OVA1 will enable gynecologists and physicians to diagnose the possibility that a woman's mass is benign or malignant in a more accurate and effective manner. OVA1 can also help prevent incidences of double surgeries, thereby reducing pain, cost, and emotional trauma to the patient."
In a prospective clinical study, OVA1, when combined with pre-surgical clinical and radiological assessments and used by non-gynecologic oncologists, detected 92 percent of malignant ovarian masses compared to 72 percent 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.
Ovarian cancer is the third leading cause of cancer deaths in India. Every year almost 30,000 women are diagnosed with ovarian cancer and over 20,000 succumb to the disease. "Quest Diagnostics is committed to helping women with cancer. We will continue to introduce innovative and world class diagnostics solutions, like Ova 1, to raise the standard of cancer diagnostics in India." said Sumit Dutta, MD, Vice President & General Manager, Quest Diagnostics India.
OVA1 is the first 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 proprietary 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.