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General Health : Government Last Updated: Apr 20, 2011 - 9:38:09 AM

FDA: LabCorp can't sell ovarian cancer test
By Jimmy Downs
Oct 9, 2008 - 11:14:26 AM

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THURSDAY October 9, 2008 ( -- The U.S. Food and  Drug Administration has issued a letter to warn Burlington-based Laboratory Corporation of America Holdings that it is violating the law by selling a blood test for ovarian cancer.

In the letter dated Sep 29 and addressed to LabCorp president and CEO David P. King, Steven I. Gutman, director in the office of In Vitro Diagnostic Device Evaluation and Safety with the FDA says the company's test  OvaSure needs the agency approval.

The issue came to the attention of the FDA after LabCorp published a press release on its website about the test.  The  FDA reviewed the information released by the company on the website and directly to the agency and it determined that there are serious regulatory problems with the test.

Normally, a company may provide a service that is fully developed by its scientists. In the case of OvaSure, Gutman points out in the letter that "the product is a test that was designed, developed and validated by investigators at Yale University and not LabCorp."

The blood test indicated for diagnosis of ovarian caner appears to have bee reported by Gil Mor and David Ward at Yale School Medicine and the Nevada Cancer Institute in the May 10, 2005 issue of Proceedings of the National Academies of Sciences.

The blood test based on four proteins is able to detect ovarian cancer in its very early stages with few symptoms present when the disease is most treatable, according to the study authors.

Based on the blood screening method, if two or more of these biomarkers in a patient falls into a warning area, the results indicate that she has the disease.

The blood screening method was tested in over 200 ovarian cancer patients and healthy women. The accuracy of a positive prediction is at the level of 95 percent and the accuracy of a negative prediction is also at 95 percent.

In his letter, Gutaman cites section 201(h) of the Food, Drug, and Cosmetic Act (FDCA or Act), 21 U.S.C. 321(h) saying that  devices like the test intended for use in the diagnosis of disease or other conditions, or in the cure, treatment, prevention, or mitigation of disease need to get approved by the FDA before they can be sold.

Gutman says the FDA requires that LabCorp respond to his letter within 15 days to advise the agency how the company will do to correct the violation.  He warns that failure to do so may result in regulatory actions including, but not limited to, seizure, injunction and or civil money penalties.

The warning letter was also sent to some other federal agencies which may consider this information when awarding government contracts.

A health observer said that if LabCorp's OvaSure is allowed, the landscape for the screening and treatment of ovarian cancer could forever change.

Epithelial ovarian cancer which hits 21,000 and kills 15,000 each year in the United States is three times more deadly than breast cancer in the U.S. Its diagnosis is difficult because few symptoms show up until its advanced stages.

Eric Lindblom, a spokesman for LabCorp, was cited as as saying the company is in talks with the FDA to determine its next steps.

"LabCorp is committed to working in partnership with the FDA to address these regulatory issues," he was quoted as saying. "While we are disappointed in the letter ... we share the FDA’s interest in avoiding unnecessary regulatory burdens in diagnostic testing and in ensuring safety for patients."

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