by Brendon Nafziger
, DOTmed News Associate Editor | September 23, 2009
A test that identifies whether tumors found in the ovaries are malignant has received clearance from the FDA, according to a statement from Vermillion last week. The Fremont, Calif-based diagnostics company developed the test.
Named OVA1, the test analyzes a blood sample drawn from a woman with an ovarian tumor and checks for five biomarkers that indicate the presence of cancer. An algorithm is then applied to the results to determine the likelihood that the tumor is malignant.
"The test is able to identify over 90 percent of cancer cases and is also able to rule out the absence of cancer over 90 percent of the time," Gail Page, president and chairperson of the board of Vermillion, told DOTmed Business News. "Moreover, the test detected 100 percent of stage II-IV [advanced] cancer."
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The main purpose of the test is to determine whether the patient should see a gynecologic oncologist, as surgical outcomes are better for women with malignant tumors who see these specialists. According to Page, women with cancerous ovarian tumors are around 10 percent more likely to survive if the tumors are excised by a gynecologic oncologist.
"The gynecologic oncologist is better trained at debulking the cancer, i.e. in removing as much tumor as possible," Page explained. "The debulking surgery is far more complex than the surgery required to remove a simple cyst, and involves removing the ovaries, taking biopsies of relevant organs (e.g. lymph nodes, diaphragm, etc), and performing pelvic washings." Gynecologic oncologists are also better able to determine how much the cancer has spread, Page added.
"This test is not intended to determine whether the subject requires surgery," Page cautioned. "Additionally, the test should be used in the context of a complete clinical evaluation, which includes physical and radiological examination."
Research into the test has been ongoing for about nine years, and comes from the field of proteomics, or protein-detection, technology. Page predicts that tests like OVA1 will become more common for diagnosing other diseases.
According to the National Cancer Institute, almost 15,000 women in the United States died last year from ovarian cancer.