LabCorp Illegally Marketing Ovarian Cancer Test Without FDA Approval, Agency Says

Main Category: Ovarian Cancer
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 13 Oct 2008 - 1:00 PDT

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FDA has sent a warning letter to Laboratory Corporation of America informing the company that it is illegally marketing a blood test to detect ovarian cancer in its early stages without agency approval, the New York Times reports. The $220 test, called OvaSure, was released in June under a rule that exempts tests from FDA regulation that are developed and marketed by a single company. However, because the ovarian cancer test was developed at Yale University, not at LabCorp, and uses materials not manufactured by LabCorp, the company must obtain FDA approval before marketing, the letter said (Pollack, New York Times, 10/9). The company must "take prompt action to correct these violations," according to the letter, which was sent to the company Sept. 29 and posted on the FDA Web site Wednesday.

LabCorp has marketed OvaSure as a way to detect early-stage ovarian cancer in women at high risk of the disease. Ovarian cancer has a five-year survival rate of 92% when detected before it spreads, but only 19% of cases are detected that early; the five-year survival rate drops to 30% when the cancer is found in later stages, Reuters reports (Richwine, Reuters, 10/8).

The test has been subject to previous criticism from FDA and some outside experts, including the Society of Gynecologic Oncologists, about its accuracy and whether it might lead women to have unnecessary surgeries to remove their ovaries. FDA in an earlier warning letter to the company said the test "may harm the public health." Some cancer specialists are concerned that the test could produce too many false positives -- leading to unnecessary ovary removal or exploratory surgery -- or false negatives, giving women a false sense of security. A study published in February in the journal Clinical Cancer Research said OvaSure correctly identified 95% of cancers in 224 samples and had a false positive rate of 0.6%.

LabCorp spokesperson Eric Lindblom said the company is "committed to working in partnership with the FDA to address the regulatory issues and will provide an update as soon as we can" (Beck, Wall Street Journal, 10/9). He did not indicate whether OvaSure would be removed from the market (New York Times, 10/9).

Rebecca Sutphen -- director of genetic counseling and testing services at H. Lee Moffitt Cancer Center and Research Institute in Tampa, Fla., and a spokesperson for the National Ovarian Cancer Coalition -- said, "When you make a test available, then people are likely to make decisions based on the test." She added, "Obviously everyone is on the same page in terms of wanting such a test. But women may be using this information prematurely to make decisions, and the decisions may not be in their best interest" (Wall Street Journal, 10/9).

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