ovasure, ovarian cancer, tests for ovarian cancer

FDA Says Unapproved Cancer Test Illegal

October 10, 2008 11:32 AM
by Emily Coakley
A new test for ovarian cancer that hasn’t been approved by the U.S. Food and Drug Administration is being sold illegally, the agency said.

Test Originally Sold Through Loophole

Last week, the FDA told Laboratory Corporation of America that selling a test for ovarian cancer, called OvaSure, is illegal because the test doesn’t have the agency’s approval, Reuters reported. OvaSure came on the market earlier this year.

The company’s spokesman, Eric Lindblom, told Reuters, “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.”

The FDA sent LabCorp a letter questioning their marketing information, which included statistics taken from a study published earlier this year.

“Based on the available information, we do not believe the scientific community would consider the reported study sufficient to establish performance characteristics of a test in ‘high risk women who might have ovarian cancer’, i.e., in a clinical setting, as claimed in your intended use and promotional materials. [W]e believe you are offering a high risk test that has not received adequate clinical validation, and may harm the public health,” wrote Steven Gutman of the Center for Devices and Radiological Health.

LabCorp was able to sell the test because of a “technicality under which the FDA doesn’t regulate tests produced and developed at one laboratory,” reported the Triangle Business Journal. But because the FDA claims it has determined that Yale University developed part of OvaSure, the agency decided it did have jurisdiction.

The Journal, citing the FDA’s letter, said consequences for not following the agency’s rules “could include seizure, injunction or monetary fines. The letter also states that other federal agencies receive copies of warning letters so they may consider that information when awarding government contracts.”

Last month, the Associated Press reported on another effort to develop an ovarian cancer test by using a tumor marker. Most work is still in the early stages.

“In fact, U.S. and British scientists are just beginning studies specially designed to prove if signs of ovarian cancer can be measured reliably in blood months, even a year, before a tumor becomes life-threatening,” AP said.

Opinion & Analysis: Difficult to detect; lack of approval a concern

Dana Blankenhorn of ZDNet Healthcare said there are two clear sides to the OvaSure controversy: “Ovarian cancer is hard to detect, it runs in families, and it’s hard to treat unless it’s detected very early. Want to lose a loved one who could have been saved? On the other hand, do you want a hysterectomy after an inaccurate test? Want to watch a loved one die after a false negative?”

Charlotte Thompson, a California doctor who writes on the blog Dr. Thompson’s Blog, is concerned that the FDA hasn’t reviewed or approved OvaSure.

“It is worrisome that labs will advertise and perform tests without the certainty that the results will be helpful. Of course, they are in the business of making lots of money,” she wrote in a Sept. 2 post.

Related Topic: Cracking down on unapproved drug sales

Last month, the FDA ordered two types of medications to be removed from the market because they weren’t approved. The products included substances containing a papaya derivative and an eye solution.

Reference: Ovarian cancer


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