FDA: Ovarian Cancer Test Sales Illegal

Oct. 08, 2008— -- WASHINGTON, Oct 8 (Reuters) - Laboratory Corp of America (LH.N: Quote, Profile, Research, Stock Buzz) is violating the law by selling an ovarian cancer screening test without regulatory approval, U.S. health officials said on Wednesday.The OvaSure test does not fall in a category that can be sold without prior clearance from the agency, the Food and Drug Administration said."Because you do not have marketing clearance or approval from the FDA, marketing OvaSure is in violation of the law," the agency said in a letter dated Sept. 29.The agency told the company 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.The company started selling the blood test in June, saying it could detect early-stage ovarian cancer in high-risk women.More than 21,000 women will be newly diagnosed with ovarian cancer in 2008 and more than 15,000 women will die from the disease, according to American Cancer Society estimates.The five-year survival rate is 92 percent if the cancer is caught before it spreads, but 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. A study of high-risk and average-risk women found it was 95 percent accurate in detecting ovarian cancer, LabCorp said when it announced the product's launch in June. False positives occurred for 0.6 percent of women.Some doctors have complained the test does not have enough data behind it to support routine use.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."The FDA letter was posted on the FDA website hereLabCorp shares fell nearly 1.8 percent to close at $60.63 on the New York Stock Exchange. (Reporting by Lisa Richwine; Editing by Dave Zimmerman and Tim Dobbyn)