Laboratory Corp of America (LabCorp) is in violation of the law by selling an ovarian cancer screening test without regulatory approval, U.S. health officials said yesterday. LabCorp’s OvaSure test does not fall in a category in which it can be sold without prior clearance from the agency, the U.S. Food and Drug Administration (FDA) said.
“Because you do not have marketing clearance or approval from the FDA, marketing OvaSure is in violation of the law,” the FDA said in a September 29 letter. The FDA also told LabCorp to “take prompt action to correct these violations.” LabCorp spokesman Eric Lindblom said the company was “disappointed” by the letter. “We are currently in discussions with the FDA over the next steps and of course we share the FDA’s determination to assure patients are protected,” he said.
LabCorp began selling the OvaSure blood test in June, saying it could detect early-stage ovarian cancer in high-risk women. According to American Cancer Society estimates, over 21,000 women will be newly diagnosed with ovarian cancer in 2008 and over 15,000 women will die from the disease. The five-year survival rate is about 92 percent if the cancer is caught before it spreads; however, only about 19 percent of cases are detected at that stage. When the cancer is discovered in advanced stages, five-year survival drops to 30 percent.
The OvaSure test was developed by researchers at Yale University and a study of high-risk and average-risk women found that OvaSure was 95 percent accurate in detecting ovarian cancer, according to LabCorp when it announced the product’s launch this June. False positives occurred in 0.6 percent of women.
Meanwhile, some doctors have reported that the OvaSure test does not have enough data behind it to support its routine use. Also, the Society of Gynecologic Oncologists, in a statement issued in July, said “additional research is needed to validate the test’s effectiveness before offering it to women outside of the context of a research study.”
Ovarian cancer is cancer that forms in tissues of the ovary, which is one of a pair of female reproductive glands in which the ova, or eggs, are formed. Most ovarian cancers are either ovarian epithelial carcinomas—cancer that begins in the cells on the surface of the ovary—or malignant germ cell tumors, which is cancer that begins in egg cells. In 2008 in the United States, there were an estimated 21,650 new cases of ovarian cancer and an estimated 15,520 deaths.
While, early ovarian cancer may not cause obvious symptoms, as the cancer grows, symptoms may include pressure or pain in the abdomen, pelvis, back, or legs; a swollen or bloated abdomen; nausea, indigestion, gas, constipation, or diarrhea; and feeling very tired all the time. Some less common symptoms include shortness of breath; feeling the need to urinate often; and unusual vaginal bleeding, heavy periods, or bleeding after menopause. These symptoms are often not due to cancer, but only a doctor can confirm a cancer diagnosis.
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